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Formulations containing high levels of glycerol or salt are difficult to lyophilize. Contact us and we can provide suggestions tailored to your specific reagents. Read more in "Your Guide to Outsourcing Reagent & Assay Lyophilization".
A: At production scale, units can be produced inexpensively in the same lyophilizer run. The initial investment in lyophilization services is quickly repaid with reduced cold chain expenses, fewer user errors, and longer expiration windows. You can read more about cold chain costs and how lyophilization can be a solution for you in “Protecting Your Life Science Cold Chain From Styrofoam Bans” and in the case study “How to Eliminate Hidden Cold Chain Costs- Lyophilizing Diagnostic Assays“. You can also read about cost benefits of lyophilizing your products in the case study “Increase Your Profit Margin with Lyophilization: Benefits for Reagent Kits & Diagnostics“.
A: Formulations containing high levels of glycerol or salt are difficult to lyophilize. Contact us and we can provide suggestions tailored to your specific reagents. Read more in “Your Guide to Outsourcing Reagent & Assay Lyophilization“.
A: Yes, your product can be produced to cGMP compliance. Argonaut offers full cGMP manufacturing capabilities, and our lyophilization equipment is housed within our ISO manufacturing suites. You can read our commitment to quality and view our licenses, registrations and certificates here.
A: Yes, you can place your own product name and branding on Bio-Fuse.
A: Yes. We can package other components with your customized Bio-Fuse solution.
A: Yes. Use multi-axis robots/pick-place equipment with vacuum and effectors.
A: At this time we do not offer drug synthesis or production of active pharmaceutical ingredients. However, we often formulate bulk drug substance or API for our clients prior to filling.
A: Yes, Argonaut offers validated GMP storage at ambient, +4°C, -20°C, and -80°C. Other storage conditions are available upon request.
A: Argonaut can support all phases of clinical manufacturing as well as scale-up, validation, and commercial production. Our team has collective experience validating and launching dozens of successful commercial products. If you are interested in working with us to progress from clinical to commercial, please contact us to learn more.
A: Our Bausch+Ströbel VarioSys filling line has a modular design that enables the addition of syringe or cartridge filling capabilities. Additionally, we have announced a planned expansion of our drug product fill-finish capabilities, which include an additional filling line that will be validated to produce vials, cartridges, and syringes. Please contact us to learn more.
A: Argonaut can support programs up to and including SafeBridge Category 3, which includes some antibody-drug conjugates (ADCs). Please contact us for an assessment of a specific molecule.
A: We do not offer pharmaceutical lyophilization services for injectable products at this time. Please refer to our drug products manufacturing page for a full list of our fill-finish capabilities.
A: Yes. We can support manufacturing under guidance of Part 210 and Part 211.
A: Yes, and we have a strong background with Part 4 including:  21 CFR 820.20, Management Responsibility, 21 CFR 820.50 Purchasing Controls, 21 CFR 820.100 Corrective & Preventative Actions, 21 CFR820.170 Installation.
A: Yes- we support European CE Marking of in-vitro diagnostic devices. Contact us for more details.
A: Yes, our Bausch+Ströbel VarioSys filling line is paired with SKAN isolators.
A: LyoDots are delivered in sheets or reel-to-reel. Must be handled in a low humidity environment.
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Establishing a successful partnership with a CDMO requires careful planning, clear communication, and ongoing collaboration.

Here are some key steps to ensure a fruitful partnership:

Due diligence: Perform thorough research on potential CDMO partners, assessing their track record, capabilities, capacity, quality systems, and regulatory compliance. Choose a CDMO that aligns with your company’s needs and values.

Establish clear expectations: Clearly define your project goals, deliverables, and expectations at the outset of the partnership. This includes specifications for product quality, timelines, and any unique requirements.

Develop comprehensive agreements: Create detailed contracts that outline the roles and responsibilities of both parties, including intellectual property protection, payment terms, quality standards, and regulatory compliance.

Open communication: Establish and maintain open lines of communication with your CDMO partner. Regularly discuss project updates, potential issues, and any changes to the scope of work to ensure transparency and alignment.

Assign a dedicated team: Designate a project manager or team within your organization to work closely with the CDMO, overseeing project progress and ensuring that your company’s needs are met.

Engage in tech transfer: Work closely with the CDMO during the tech transfer process, sharing critical information and providing guidance to ensure a smooth transition and successful scale-up.

Monitor progress and performance: Request regular updates on manufacturing schedules, quality control results, and any challenges encountered. Use this information to make informed decisions and address potential issues proactively.

Perform audits and inspections: Conduct regular audits and inspections of the CDMO’s life science and IVD manufacturing facilities to ensure adherence to quality standards, regulatory requirements, and contract terms.

Foster a collaborative relationship: Build a strong working relationship with your CDMO partner through open communication, mutual trust, and shared goals. Work together to address any challenges that may arise and support each other’s success.

Plan for contingencies: Develop contingency plans for potential risks, such as supply chain disruptions, production delays, or regulatory changes. This can help you respond more effectively to unexpected challenges and minimize their impact.

By following these steps and working closely with a reputable CDMO like Argonaut, you can establish a successful partnership that supports your life science or IVD manufacturing needs and helps your company achieve its strategic objectives.

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Maintaining control over your product development and life science or IVD manufacturing process while working with a CDMO is essential for ensuring the success of your collaboration.

Here are some key strategies to help you maintain control and stay engaged throughout the process:

Clear communication: Establish open and effective communication channels with your CDMO. Regularly discuss project updates, potential issues, and any changes to the scope of work. This ensures that both parties are aligned and helps to maintain transparency.

Establish expectations: Clearly define expectations, project goals, and deliverables at the outset of the partnership. This includes specifying quality standards, timelines, and any specific requirements for your product.

Project management: Assign a dedicated project manager or team to work closely with the CDMO, overseeing the project’s progress and ensuring that your company’s needs and expectations are met.

Detailed agreements: Develop comprehensive contracts and agreements that outline the responsibilities of each party, including intellectual property protection, quality standards, regulatory compliance, and any other relevant aspects of the collaboration.

Regular progress updates: Request regular progress reports from the CDMO, including updates on manufacturing schedules, quality control results, and any challenges encountered. This helps you stay informed and facilitates proactive decision-making.

In-person or virtual meetings: Schedule periodic in-person or virtual meetings with the CDMO to review project progress, discuss any concerns, and maintain a strong working relationship.

Conduct audits and inspections: Perform regular audits and inspections of the CDMO’s life science and IVD manufacturing facilities to verify that they adhere to your company’s quality standards and regulatory requirements. This also provides an opportunity to review their processes and make suggestions for improvement.

Active involvement: Stay actively involved in key decision-making processes, such as selecting raw materials, finalizing manufacturing processes, and approving quality control methods. This ensures that your company’s interests are well-represented throughout the collaboration.

By implementing these strategies, you can maintain control over your product development and life science or IVD manufacturing process while leveraging the expertise and capabilities of a CDMO like Argonaut. A successful partnership with a CDMO can provide significant benefits, including cost savings, access to specialized expertise, and increased capacity, while allowing your company to focus on its core competencies.

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CDMOs play a crucial role in ensuring the quality of the products they manufacture and maintaining compliance with applicable regulations.

To achieve this, reputable CDMOs like Argonaut implement a comprehensive approach that includes the following elements:

Quality Management System (QMS): A robust QMS is the backbone of a CDMO’s quality and compliance efforts. The QMS includes policies, procedures, and guidelines that govern every aspect of the life science and IVD manufacturing process, from raw materials sourcing to finished product release.

Compliance with Good Manufacturing Practices (GMP): CDMOs adhere to GMP guidelines and other relevant industry standards to ensure that products are consistently manufactured according to quality requirements. GMP guidelines cover various aspects of the production process, including personnel qualifications, equipment maintenance, and record-keeping.

Regulatory expertise: CDMOs employ experienced regulatory affairs professionals who are knowledgeable about local and international regulations, industry standards, and best practices. These professionals help ensure that the CDMO stays up-to-date with the latest regulatory changes and maintains compliance throughout the life science or IVD manufacturing process.

Regular audits and inspections: CDMOs undergo regular audits and inspections by both their clients and regulatory authorities to verify that they maintain compliance with applicable regulations and quality standards. These inspections help identify potential issues and ensure that corrective actions are taken promptly.

Employee training: CDMOs invest in continuous training and education for their employees to ensure that they have the necessary skills and knowledge to maintain quality and compliance. This includes training on relevant regulations, industry standards, and best practices.

Quality control and assurance: CDMOs implement rigorous quality control (QC) and quality assurance (QA) processes throughout the life science and IVD manufacturing process. QC involves testing and monitoring of raw materials, intermediate products, and finished products to ensure that they meet established specifications. QA focuses on the overall quality management system and helps identify and address potential issues before they impact product quality.

Documentation: CDMOs maintain thorough and accurate documentation of their life science and IVD manufacturing processes, quality control results, and compliance efforts. Proper documentation is essential for demonstrating compliance with regulations and facilitating audits and inspections.

Continuous improvement: CDMOs are committed to continuous improvement in their quality and compliance efforts. They regularly review their processes, systems, and performance to identify areas for improvement and implement necessary changes.

By implementing these measures, reputable CDMOs like Argonaut can ensure that they consistently deliver high-quality products while maintaining compliance with applicable regulations. Partnering with a CDMO that prioritizes quality and regulatory compliance can provide peace of mind and help minimize potential risks associated with life science or IVD manufacturing.

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Here are some key considerations to help guide your decision-making process:

Core competencies: Assess your company’s strengths and weaknesses. If your core competencies lie in research and development, product innovation, or marketing, rather than manufacturing, it might make more sense to outsource life science and IVD manufacturing to a CDMO with specialized expertise in this area.

Financial considerations: Analyze the cost of setting up and maintaining an in-house life science and IVD manufacturing facility versus outsourcing to a CDMO. Consider factors such as capital investments, ongoing operational expenses, labor costs, and regulatory compliance. In many cases, outsourcing can be more cost-effective, allowing you to allocate resources to other essential areas of your business.

Capacity and scalability: Evaluate your company’s current and future manufacturing needs. If you anticipate fluctuations in demand, a CDMO can offer the flexibility to scale production up or down as needed. Outsourcing can also help you avoid the challenges of managing and maintaining additional manufacturing capacity.

Time to market: Determine how quickly you need to bring your product to market. Outsourcing life science and IVD manufacturing to a CDMO can help accelerate the development process, allowing you to focus on other critical aspects of getting your product to market.

Regulatory compliance and quality control: Consider the complexities of meeting regulatory requirements and maintaining quality control in-house. A reputable CDMO will have established quality management systems and adhere to cGMP guidelines, ensuring your product is manufactured to the highest standards and meets all regulatory requirements.

Risk management: Outsourcing life science and IVD manufacturing can help mitigate risks associated with production, such as delays, equipment malfunctions, or supply chain disruptions. A CDMO can provide a stable and reliable manufacturing environment that minimizes risks and ensures your product is produced on time and within budget.

Intellectual property protection: Ensure that the CDMO you are considering has robust intellectual property protection policies in place to safeguard your proprietary information and technology.

After evaluating these factors, if you find that outsourcing manufacturing of your IVD, POCT or RUO product offers significant advantages in terms of cost savings, flexibility, risk mitigation, and faster time to market, it may be the right choice for your company. Partnering with a reputable CDMO like Argonaut can provide the support and expertise you need to successfully manufacture your biotech products while allowing your company to focus on its core competencies.

See the case study: A Customer Case Study in Strategic Outsourcing: Key Decisions and Processes for more detailed thinking.
A: The proprietary adherent surface on a LyoDots ensures the lyophilized reagents maintain positional correctness and physical stability while allowing the production of formulated reagents to <2ul.
A: LyoDots are designed for cartridges or automation with 1 to 16 reactions. LyoDots reconstitute immediately without exhibiting out-gassing that can complicate microfluidics
A: Turnaround times on lyophilization are usually quick, often 1-2 weeks. If you plan to manufacture under cGMP please allow time for documentation and technology transfer. Read more in “Your Guide to Outsourcing Reagent & Assay Lyophilization” and in the case study “Increase Your Profit Margin with Lyophilization: Benefits for Reagent Kits & Diagnostics”.
A: Lyophilization is a complex process that requires extensive optimization. Argonaut has decades of experience in setting these parameters and selecting excipients. As a result, our lyophilization feasibility program has a high success rate in achieving a suitable product. You can read more about obstacles and challenges in protein lyophilization in “How to Overcome Your Protein Lyophilization Roadblocks
A: No- we are a dedicated manufacturing services company. We do not compete with our clients.
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While engaging a CDMO early in the development process can offer many benefits, it is possible to involve them too early in certain circumstances.

Here are some situations where early engagement might not be as advantageous:

Undefined project scope or requirements: If your project scope or requirements are not yet well-defined or subject to significant changes, engaging a CDMO too early could lead to inefficiencies or the need for adjustments later on. It might be more appropriate to wait until your project scope is more clearly established before engaging a CDMO for your life science or IVD manufacturing.

Limited resources: For startups or smaller companies with limited resources, engaging a CDMO too early may consume valuable funds that could be allocated to other essential aspects of the business, such as research and development. In such cases, it’s crucial to carefully assess your financial situation and prioritize your investments strategically.

In-house capabilities: If your company has robust in-house capabilities for early-stage development and life science or IVD manufacturing, it might not be necessary to engage a CDMO at the earliest stages. However, you should still consider the long-term benefits of working with a CDMO and when it might be appropriate to transition from in-house to outsourced manufacturing.

Need for further evaluation: In some cases, you may need more time to evaluate different CDMOs and determine which one is the best fit for your specific needs. Engaging a CDMO too early could limit your ability to explore alternative options and make an informed decision.

To avoid engaging a CDMO too early, it’s essential to carefully assess your project’s stage, resource availability, and in-house capabilities. The optimal time to engage a CDMO will vary depending on your unique situation, but generally, it is advantageous to involve them early enough to benefit from their expertise, streamline tech transfer, and plan resources effectively.

In conclusion, while it is possible to engage a CDMO too early in some cases, a well-timed partnership with a reputable CDMO like Argonaut can provide significant benefits throughout your product’s development process and life science or IVD manufacturing. Carefully evaluate your company’s specific needs and resources to determine the most appropriate time to engage a CDMO for your project.

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There can be distinct advantages of moving to contract manufacturing if your product is already in production.

Here are some factors to consider when deciding whether to engage a CDMO when your product is in production:

Capacity constraints: If your current production capacity is insufficient to meet growing demand for your life science or IVD manufacturing, or you need to scale up quickly, engaging a CDMO can provide the additional capacity required to support your expansion.

Cost optimization: A CDMO can offer cost efficiencies by leveraging their expertise, specialized equipment, and established supply chains. This can result in reduced production costs and increased profitability.

Focus on core competencies: Outsourcing production to a CDMO allows your company to focus on its core competencies, such as research and development, sales and marketing, or expanding your product portfolio.

Regulatory compliance: A CDMO with experience in regulatory compliance can help ensure that your product continues to meet the necessary standards and requirements, potentially reducing the risk of non-compliance issues.

However, there are challenges to consider when transitioning to a CDMO during the production phase:

Tech transfer complexities: Transferring production to a CDMO at this stage can be more complex and time-consuming, as they will need to adapt to your processes, equipment, and requirements. This can result in delays and increased costs.

Intellectual property protection: Ensuring the protection of your intellectual property during the transition to a CDMO is critical. It’s essential to establish a clear agreement outlining the terms of the partnership and the measures in place to protect your intellectual property.

Potential production disruption: Transferring production to a CDMO can help minimize these disruptions.

In conclusion, while it may be more challenging to engage a biotech contract manufacturer during the production phase, it is not too late to do so. Carefully weighing the potential benefits and challenges can help you determine if partnering with a CDMO like Argonaut is the right decision for your product at this stage. A successful transition can provide additional capacity, cost optimization, and allow your company to focus on its core competencies.

A: Argonaut has a full service analytical lab supporting for in-process, release, and stability testing. Please see our QC page for a more comprehensive description.
A: Argonaut is the exclusive supplier of LyoDose™ beads, which are unit-dose lyophilized spheres. LyoDose™ beads offer significant advantages including faster reconstitution time, improved user experience, and reduced contamination risk. You can rad more about lyophilized beads in “Three Reasons Why Lyophilized Beads are the Next Big Thing in Assay Design“.
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There are various reasons why a company might decide to transfer a product already in production to a CDMO.

Some common reasons include:

Capacity constraints: If a company’s current life science or IVD manufacturing capacity is insufficient to meet growing demand, transferring production to a CDMO can provide the necessary additional capacity to support expansion.

Cost reduction: Engaging a CDMO can offer cost efficiencies through their specialized equipment, economies of scale, and established supply chains. This can result in reduced production costs and increased profitability for the company.

Focus on core competencies: Outsourcing life science or IVD manufacturing to a CDMO allows a company to concentrate on its core competencies, such as research and development, sales and marketing, or expanding its product portfolio.

Technical expertise: A CDMO can provide specialized technical expertise that might not be available in-house, enabling manufacturing of complex or specialized products that require advanced life science or IVD manufacturing techniques or equipment.

Regulatory compliance: CDMOs with experience in regulatory compliance can help ensure that a product continues to meet the necessary standards and requirements, potentially reducing the risk of non-compliance issues and associated costs.

Risk mitigation: Engaging a CDMO can help maintain continuity of supply during this transition period.

Geographical expansion: A company looking to enter new markets or expand its global footprint may choose to partner with a CDMO with established facilities in the target region, enabling more efficient distribution and reducing logistical challenges.

While transferring a product already in production to a CDMO can present challenges, such as tech transfer complexities and potential manufacturing disruptions, the benefits can outweigh the drawbacks. By carefully considering the reasons for transferring life science or IVD manufacturing and selecting a reputable CDMO like Argonaut, companies can gain additional capacity, cost optimization, and access to specialized expertise while focusing on their core competencies.

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Outsourcing your life science or IVD manufacturing to a CDMO can provide significant benefits, but there are also potential challenges and pitfalls that you should be aware of.

Being mindful of these potential issues can help you mitigate risks and ensure a successful partnership:

Poor communication: Ineffective communication between your company and the CDMO can lead to misunderstandings, delays, or errors. It is essential to establish open and clear communication channels to avoid these issues.

Intellectual property protection: Ensuring the protection of your intellectual property (IP) is critical when working with a CDMO. Make sure to have comprehensive agreements in place that address IP ownership, confidentiality, and non-disclosure.

Quality control and regulatory compliance: Inadequate quality control processes or non-compliance with regulations can lead to product recalls, legal issues, or damage to your company’s reputation. It is essential to select a CDMO with a strong track record in quality and regulatory compliance.

Misaligned expectations: Clearly define your expectations, project goals, and deliverables at the outset of the partnership to avoid misalignment and potential conflicts.

Inadequate capacity or capabilities: Ensure that the CDMO you choose has the necessary capacity and capabilities to meet your life science or IVD manufacturing requirements. Inadequate capacity or capabilities can lead to delays, increased costs, or subpar product quality.

Tech transfer difficulties: The process of transferring your product’s manufacturing technology and know-how to the CDMO can be complex and time-consuming. Poorly executed tech transfers can result in production delays, increased costs, or product quality issues.

Supply chain disruptions: Outsourcing your life science or IVD manufacturing can introduce new risks in the supply chain, such as delays in raw material deliveries, customs clearance issues, or transportation disruptions. It is crucial to assess and manage these risks proactively.

Cultural differences and language barriers: When partnering with a CDMO in a different country, cultural differences and language barriers can pose challenges in communication and collaboration. Be prepared to address these issues and ensure effective communication.

Overreliance on a single CDMO: Relying solely on one CDMO can lead to a lack of diversification and increased risk. Consider partnering with multiple CDMOs to build redundancies and reduce potential risks.

By carefully considering these potential challenges and pitfalls, and selecting a reputable CDMO like Argonaut, you can mitigate risks and build a successful partnership that supports your life science or IVD manufacturing needs and helps your company achieve its strategic goals.

For more information, read the post: Key Factors in Choosing the Right Biotechnology Contract Manufacturer.

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Selecting a CDMO early in the development process can offer several advantages, as well as some potential disadvantages. It’s essential to weigh these factors carefully to make the best decision for your company.

Advantages of selecting a CDMO early:

Expertise and collaboration: Engaging with a CDMO early for life science or IVD manufacturing allows you to benefit from their specialized knowledge and expertise throughout the development process. This collaboration can lead to more efficient and effective strategies, ultimately improving the overall success of your product.

Streamlined tech transfer: Early engagement with a CDMO can facilitate a smoother technical transfer of your product from development to manufacturing. This can reduce the risk of delays or issues during scale-up and ensure a more efficient transition.

Resource planning and allocation: Early involvement with a CDMO provides better visibility into the resources, timelines, and costs associated with life science and IVD manufacturing. This can help you make more informed decisions regarding resource allocation and project planning.

Faster time to market: Selecting a CDMO early can help accelerate the product development and commercialization timeline, enabling you to bring your product to market more quickly and potentially gain a competitive advantage.

Risk mitigation: Early collaboration with a CDMO allows for more effective risk management throughout the product lifecycle. By identifying and addressing potential challenges or issues before they become critical, you can minimize the likelihood of delays, regulatory non-compliance, or unexpected costs.

Disadvantages of selecting a CDMO early:

Potential changes in project scope: In the early stages of development, the project scope or requirements may change as new information becomes available. This could necessitate adjustments in the CDMO partnership or agreement, potentially leading to additional costs or delays.

Limited flexibility: Selecting a CDMO early in the development process may limit your flexibility to explore alternative life science and IVD manufacturing options or partners if unforeseen circumstances arise.

Initial investment: Engaging with a CDMO early in the development process may require an upfront investment, which may be a concern for smaller companies or startups with limited resources.

In summary The advantages of selecting a CDMO early in the development process generally outweigh the potential disadvantages. Early engagement can lead to more efficient collaboration, streamlined tech transfer, better resource planning, faster time to market, and effective risk mitigation. By partnering with a reputable CDMO like Argonaut, you can maximize these benefits and position your product for success while still focusing on your core competencies. However, it is essential to carefully consider the potential disadvantages and weigh them against your company’s specific needs and resources.

For a deeper look into Early Development vs Late Development vs Post Production, please read the case study: When is the Right Time to Select a Biotech Contract Manufacturer (CMO)? The study also discusses if it is possible to engage a CDMO too early.

A: Lyophilization offers many advantages, including cost savings, improved user experience, and environmental responsibility. You can read about cost benefits of lyophilizing your products in the case study “Increase Your Profit Margin with Lyophilization: Benefits for Reagent Kits & Diagnostics“.
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Outsourcing life science or IVD manufacturing to a CDMO can provide several benefits to companies, both in terms of operational efficiency and overall business strategy.

Some key benefits include:

Cost savings: CDMOs can offer cost efficiencies due to their specialized life science or IVD manufacturing equipment, economies of scale, and established supply chains. This can result in reduced production costs, allowing companies to allocate resources more effectively.

Access to expertise: CDMOs possess specialized knowledge and technical expertise in various life science or IVD manufacturing processes, regulatory compliance, and quality assurance. Partnering with a CDMO can provide access to this expertise, enabling the production of complex or specialized products that may not be feasible in-house.

Capacity expansion: Engaging a CDMO can provide additional life science or IVD manufacturing capacity, enabling companies to scale up production quickly and efficiently to meet growing demand or enter new markets.

Focus on core competencies: Outsourcing life science or IVD manufacturing allows companies to concentrate on their core competencies, such as research and development, sales and marketing, or expanding their product portfolio. This can lead to improved efficiency and innovation in these areas.

Risk mitigation: Partnering with a CDMO can help companies mitigate risks associated with life science or IVD manufacturing, such as supply chain disruptions, facility closures, or regulatory non-compliance. CDMOs can also provide additional resources for problem-solving and troubleshooting, reducing the impact of unforeseen issues on the company’s operations.

Accelerated time to market: CDMOs can streamline the transition from development to manufacturing, helping companies bring their products to market more quickly and efficiently.

Flexibility and agility: CDMOs can provide flexibility and agility in responding to changing market conditions or customer needs, allowing companies to adapt more effectively to evolving circumstances.

Geographical advantages: Partnering with a CDMO with facilities in key markets or regions can help companies optimize distribution and logistics, reduce shipping costs, and facilitate access to local resources and expertise.

In conclusion, outsourcing life science or IVD manufacturing to a reputable CDMO like Argonaut, companies can reap these benefits and more, enhancing their operational efficiency, expanding capacity, and focusing on their core competencies. This strategic partnership can ultimately lead to improved competitiveness and long-term success in the marketplace.

A: Your advantages include stricter quality control, access to research institutions, skilled workforce, regulatory familiarity for US domestic production, and reduced transportation costs.
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Selecting a biotech contract manufacturer (CDMO) late in the development phase has its pros and cons. It’s essential to carefully consider these factors to make the best decision for your company.

Pros of selecting a CDMO late in the development phase:

Well-defined project scope: By waiting until later in the development process, your project scope and requirements are more likely to be well-defined and stable. This can make it easier to identify the most suitable CDMO for your specific needs and ensure a more efficient collaboration for your life science or IVD manufacturing.

Financial flexibility: Delaying the engagement of a CDMO can provide financial flexibility, particularly for startups or smaller companies with limited resources. By focusing on other aspects of the business, such as research and development, you can allocate resources more effectively.

Evaluation time: Selecting a CDMO late in the development phase allows for more time to evaluate different CDMOs and make an informed decision based on your unique life science or IVD manufacturing requirements.

Cons of selecting a CDMO late in the development phase:

Missed opportunities for collaboration: By engaging a CDMO later in the development process, you might miss out on valuable opportunities for collaboration and input from their specialized expertise. This can impact the overall efficiency and effectiveness of your product development.

Tech transfer challenges: Engaging a CDMO late in the development process can lead to a more complicated and time-consuming tech transfer, as the CDMO may need more time to understand and adapt to your processes and requirements.

Longer time to market: Delaying the engagement of a CDMO can result in a longer time to market, as the transition from development to scale-up and manufacturing may be more challenging and time-consuming.

Resource planning difficulties: Engaging a CDMO late in the development process can make it more difficult to plan and allocate resources effectively, potentially leading to delays or budget overruns.

In summary While there are some benefits to selecting a biotech contract manufacturer late in the development phase, the potential drawbacks can have a significant impact on your product’s success. Engaging a reputable CDMO like Argonaut early in the development process can provide valuable collaboration opportunities, streamline tech transfer, and help ensure a more efficient and successful product development and life science or IVD manufacturing process. It’s essential to carefully weigh the pros and cons based on your specific needs and resources before deciding when to engage a CDMO.

For a deeper look into Early Development vs Late Development vs Post Production, please read the case study: When is the Right Time to Select a Biotech Contract Manufacturer (CMO)? The study also discusses if it is possible to engage a CDMO too early.

A: Standard sizes are 0.5ml-3.0ml but custom sizes can be accommodated.
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The cost of outsourcing your life science or IVD manufacturing to a CDMO can vary significantly depending on several factors, such as the complexity of your product, the scale of production, the CDMO’s expertise and capabilities, and the scope of services required.

To better understand what to expect in terms of cost, consider the following factors:

Manufacturing complexity: Complex products, such as biologics, may require specialized equipment, advanced life science or IVD manufacturing techniques, or highly skilled personnel, leading to higher costs compared to simpler products.

Volume and scale: The cost per unit typically decreases as the volume of production increases, due to economies of scale. However, if your production requirements exceed the CDMO’s existing capacity, additional investments in equipment or facility expansion may be necessary, impacting the overall cost.

Scope of services: The cost of outsourcing will depend on the range of services you require from the CDMO, such as supply chain management, technical transfer, engineering development, regulatory support, or quality assurance. A more comprehensive scope of services will likely result in higher costs.

Development and tech transfer costs: The process of transferring your product’s life science or IVD manufacturing technology and know-how to the CDMO may require additional resources and time, impacting the overall cost of outsourcing.

Regulatory compliance and quality assurance: Ensuring that your product meets regulatory requirements and quality standards can be resource intensive. This includes the cost of implementing and maintaining a robust quality management system, as well as conducting regular audits and inspections.

Geographic location: The location of the CDMO’s facilities can impact the cost of outsourcing due to differences in labor costs, taxes, regulations, and logistics.

Contract terms and negotiation: The final cost will also depend on the specific terms and conditions negotiated in your contract with the CDMO. This can include factors such as payment terms, intellectual property rights, liability, and performance guarantees.

To get an accurate estimate of the cost of outsourcing your life science or IVD manufacturing to a CDMO, it is essential to clearly define your requirements and engage in a thorough evaluation and negotiation process. A reputable CDMO like Argonaut can help you navigate this process and provide a transparent, competitive, and fair pricing structure that takes into account your specific needs and expectations.

A: Our leadership team has extensive industry experience and has backgrounds at leading drug product manufacturers including Aji Bio-Pharma (Althea), ThermoFisher (Patheon), Vetter, Allergan, and more.
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A Contract Development Manufacturing Organization (CDMO), is a company that provides comprehensive services to biotech and pharmaceutical companies related to the development, manufacturing, and testing of drugs and other biotechnology products. CDMOs offer a wide range of services, including supply chain management, technical transfer, engineering development, first article builds, cGMP (current Good Manufacturing Practices) manufacturing, and quality and regulatory services.

There are several reasons why life science & diagnostic companies should consider working with a CDMO:

Expertise and experience: CDMOs possess specialized knowledge and expertise in the field of life science and IVD manufacturing. They are well-versed in the latest technologies, equipment, and regulatory requirements, ensuring that your product is manufactured to the highest quality standards.

Cost savings: By outsourcing life science and IVD manufacturing to a contract manufacturing organization, biotech companies can save on the costs of setting up, maintaining, and operating their own manufacturing facilities. This can free up resources that can be redirected towards research and development, allowing companies to focus on their core competencies.

Flexibility and scalability: CDMOs offer a high level of flexibility and can easily adapt to changing production needs. They can quickly scale up or down according to the client’s requirements, ensuring a seamless transition between different stages of the product lifecycle.

Risk mitigation: By working with a contract manufacturing organization, biotech companies can mitigate the risks associated with life science and IVD manufacturing, such as potential production delays or issues with regulatory compliance. CDMOs have established quality management systems and follow cGMP guidelines, ensuring that the final product meets regulatory requirements.

Faster time to market: CDMOs can help accelerate the product development process by taking care of manufacturing and related services, allowing biotech companies to focus on other aspects of bringing their product to market. This can result in faster time to market and a competitive advantage.

In summary Partnering with a CDMO can provide significant benefits to life science & diagnostic companies working with POCT (Point of Care Testing), IVD (Diagnostics) & RUO (Research Use Only) products, including cost savings, increased flexibility, risk mitigation, and faster time to market. By leveraging the expertise and resources of a CDMO like Argonaut, biotech companies can focus on their core competencies and successfully bring their products to market.

A: Lyophilization requires careful optimization of parameters. Our lyophilization feasibility program determines the best manufacturing process for your product, prior to full-scale production. The feasibility study produces small batches of lyophilized product with three different excipients (inert components that stabilize products during the lyophilization process), which are then tested. This facilitates selection of the best excipient for optimal lyophilization. You can read more about feasibility studies in “Your Guide to Outsourcing Reagent & Assay Lyophilization“.
A: Lyophilization is also known as freeze drying. It is a dehydration process that takes place after a product has been frozen. Lyophilization is gaining popularity in the life sciences for reagents and assays due to its numerous benefits, including extended shelf-life and ease-of-use. Read more in “Lyophilization Process- The Argument for Specialization“.
A: 500,000 per week.
A: We suggest starting with the Combination Products Guidance from the Office of Combination Products (OCP), FDA. https://www.fda.gov/combination-products/guidance-regulatory-information/combination-products-guidance-documents
A: Dependent on components, usually 2 years.
A: Argonaut offers a wide range of reagent lyophilization services options. Our most popular format is LyoDose™ beads, although in situ, vials, and swabs are also common. Drug products are not able to be lyophilized at this time.
A: Argonaut offers formulation, vial filling, finishing, labeling and analytical support for the biopharmaceutical industry. Please see our drug product manufacturing page for more information on the services and formats we support.
A: Various shapes are available including circular, rectangular, and semi-spherical.
A: LyoDots thickness 0.15 to 1.00 mm. Volume: 0.1 uL – 50 uL.
A: Argonaut operates a custom-designed, state-of-the-art Bausch+Ströbel VarioSys line with SKAN isolator technology. Our line utilizes Bausch+Ströbel’s ADVANCEDfill technology to maximize yield and minimize line loss. Our isolator-based filling virtually eliminates the need for human intervention.
A: We use ready-to-use, pre-sterilized nested ISO vials. Argonaut supports vial sizes from 2R through 30R.
A: With a few exceptions, most liquid reagents can be lyophilized. Examples of projects include qPCR reagents, NGS kit components, and molecular diagnostics cartridges. You can read more about lyophilization of proteins in “How to Overcome Your Protein Lyophilization Roadblocks“.
A:
Every journey to contract manufacturing is unique. Some life science & diagnostic companies know, at the start, they want to work with a contract development and manufacturing organization (CDMO), while others choose to engage a CDMO later in the product design process or even after production has started. While flexible providers will accommodate companies at any stage of their process, when is the right time to select a biotech contract manufacturer? Examining the pros and cons of early, late, and post-production engagement reveals the best time to select a CDMO.
For a deeper look into Early Development vs Late Development vs Post Production, please read the case study: When is the Right Time to Select a Biotech Contract Manufacturer (CMO)?
The study also discusses if it is possible to engage a CDMO too early.
In general, the best time to select a biotech contract manufacturer is early in your product development process. By partnering with a reputable CDMO like Argonaut, you can benefit from their expertise, streamline tech transfer, optimize resource planning, accelerate your time to market, and effectively mitigate risks. This strategic partnership can ultimately enhance your product’s success while allowing you to focus on your core competencies.
The best time to select a biotech contract manufacturer, like a CDMO, depends on several factors. Here are some reasons why early engagement with a CDMO can be beneficial:
Expertise and collaboration: By involving a contract manufacturing organization early in the process, you can leverage their specialized knowledge and expertise to help guide your product development. Their input can prove invaluable in optimizing your processes, ensuring regulatory compliance, and identifying potential challenges or bottlenecks. Early collaboration can help create a strong, synergistic partnership that sets the stage for successful outcomes.
Streamlined tech transfer: Engaging a CDMO early allows for a more efficient and seamless technical transfer of your product from development to manufacturing. The CDMO can work closely with your team to understand your processes, equipment, and requirements, resulting in a smoother transfer and reduced risk of delays or issues during scale-up.
Resource planning and allocation: Early engagement with a CDMO provides better visibility into the required resources, timelines, and costs associated with manufacturing your product. This can help you make more informed decisions about resource allocation and planning, ensuring that your project stays on track and within budget.
Faster time to market: Selecting a CDMO early in the process can help accelerate your product’s development and commercialization timeline. With a CDMO already in place, you can seamlessly transition from development to scale-up and manufacturing, reducing the time it takes to bring your product to market and giving you a competitive edge.
Risk mitigation: Early involvement with a CDMO allows for more effective risk management throughout the product lifecycle. A CDMO can help identify and address potential challenges or issues before they become critical, reducing the likelihood of delays, regulatory non-compliance, or unexpected costs.
A: Humidity will degrade the lyophilized beads.
A: Setting up biotech manufacturing in the United States can strengthen your supply chain, decrease risk, and cross-fertilize innovation between your manufacturing facilities.
A: Argonaut will likely dramatically decrease the time it takes to get your production up and running. We have a skilled workforce, large manufacturing footprint, established CRM, robotics, and established warehousing/logistics. You will save on capital infrastructure while gaining operational flexibility. As a further option, you can engage Argonaut while building out your own operation.

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