A How-To Guide: Scaling up IVD Manufacturing With a CMO

Scaling up in vitro diagnostic (IVD) device manufacturing from a pilot or small-scale operation to full-scale production is a significant milestone. There are several challenges, such as including the need for advanced infrastructure, meeting regulatory compliance, optimizing supply chains, and sustaining market-readiness without compromising product quality. Partnering with a contract manufacturing organization (CMO) is a strategic way to meet these demands and can provide the expertise and infrastructure necessary to navigate these challenges efficiently.

This guide explores the key strategies for scaling up IVD manufacturing with a CMO, offering actionable steps to guide the process.

Assessing CMOs for Scale-up

The backbone of any successful scale-up beyond expanding hiring likely involves custom manufacturing. CMOs can provide specialized services that bridge the gap between development and large-scale production. Their infrastructure and expertise allow IVD manufacturers to focus on innovation while the CMO handles the complexities of large-scale production.

Assess the track record of the CMO: Review the CMO’s portfolio for experience with IVD products. For example, if your product involves lyophilized reagents, the CMO must have experience handling temperature-sensitive processes and cryoprotectants.
Evaluate technological capabilities: CMO should have state-of-the-art facilities and equipment, such as advanced air-handling and water purification systems.
Verify compliance and certifications: Certifications such as ISO 13485 and GMP compliance are crucial for IVD manufacturing.
Visit site and perform audits: Touring the facilities can reveal their capabilities and attention to detail. Inspect the cleanliness of the facilities and cleanrooms, discuss equipment capabilities and understand their scalability potential.
Audit the supplier: Inspect and audit production procedures, quality control measures, and component traceability to ensure the integrity of materials for IVDs and that it aligns with your standards.

Establishing Clear Goals and Key Performance Indicators (KPI)

By agreeing on objectives and key performance indicators (KPIs), you and the CMO ensure that you are pursuing the same results. The foundation of a successful CMO partnership is a set of specific, quantifiable goals. You may monitor progress and guarantee alignment with production, quality, and compliance goals by establishing KPIs.

Establish measurable goals: Indicate the necessary production numbers, such as the number of units produced each week, the acceptable rate of defects, or the turnaround times for problem-solving.
Create a thorough service level agreement (SLA): Clearly state and specify the expectations, together with the deadlines, quality requirements, and resolutions for non-compliance.
Use reporting tools to keep an eye on KPIs: Use software to monitor important parameters like batch yields, cycle times, and on-time delivery rates. Promptly discuss deviations and revisit corrective actions. Be sure to schedule frequent performance evaluations.

Ensuring a Seamless Technology Transfer

Technology transfer is an important step of scaling up IVD manufacturing. It requires replicating processes without losing quality or consistency. Product integrity must maintained as production scales.

Document the process: Establish clear documentation and communication between development and manufacturing teams to ensure seamless technology transfer.
Run pilot batches: Use small batches or pilot lots as milestones to evaluate the readiness for full-scale production. This can help identify and resolve issues in the manufacturing pipeline.
Provide hands-on training: Providing training of CMO’s manufacturing staff on product specifications so they understand the intent and use of the product or device

Scaling Quality Assurance (QA) and Testing

IVD manufacturing of regulated products fall under a number of complex requirements, and compliance is required. Compliance issues can lead to batch failures, costly recalls, and reputational damage.

Good quality and compliance are important: It is imperative to adhere to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) for IVD manufacturing. Document control, training, change control and corrective and preventive action (CAPA), should all be a part of these system. This lowers the risk of possible compliance issues that could delay your product launch.
Quality system for IVD manufacturing: The Quality Management System (QMS) should be compliant with ISO 13485:2016, cGMP, and quality system regulations 21 CFR 820.
Develop a risk mitigation strategy: Develop plans for high-risk materials, such as alternative suppliers or increased quality control testing. Create action plans that address potential regulatory and quality risks, such as additional validation requirements or alternative suppliers.
Test raw materials for purity and potency: Verify that raw materials, especially sensitive reagents like antibodies and enzymes, meet specifications through rigorous testing.
Implement robust quality control checkpoints: Include in process verification of critical quality parameters at critical stages in the manufacturing process to detect and address issues early.
Documentation and record keeping: Traceability, data collection and analysis help identify and potential quality issues.

Tapping Into CMO Expertise for Regulatory Compliance

Scaling up IVD manufacturing requires meeting stringent regulatory requirements that vary by market. CMOs with regulatory expertise can help streamline this process, reducing the time and cost of approvals.

Establish regulatory milestones: Collaborate with the CMO to create regulatory deadlines including receiving FDA 510(k) clearance or CE marking. To prevent delays, include these milestones in your production timeline.
Audit regulatory documentation practices: Audit the CMO’s quality management system. Determine the CMO’s level of transparency and ability to act as a strategic partner.
Stay on top of regulatory changes: A team member or CMO representative should monitor changing laws and regulations, and evaluate how they affect your production process. Make periodic updates to your compliance roadmap to reflect these changes. Stay informed about changes in regulations that could impact manufacturing, such as ISO revisions or FDA guidance updates.

Streamlining Supply Chain Management

Efficient supply chains are critical for uninterrupted production. CMOs with established supplier networks can help mitigate risks and reduce lead times while scaling up IVD manufacturing but more importantly in maintaining the elevated capacity.

Identify trusted suppliers: To guarantee consistency in quality, look for suppliers who meet ISO 13485 and other relevant regulatory requirements.
Robust supply chain solutions and logistics planning: Choose an IVD manufacturer with well-built and integrated supply chain solutions for seamless procurement, production, and distribution. From procurement to the final product, a robust supply chain lowers the possibility of delays and improves product consistency.
Mitigate supply chain risks: Partnering with IVD manufacturers who have strong, well-established supply chains helps safeguard your IVD manufacturing process against disruptions. This helps ensure consistent and reliable delivery of your products, even in times of global uncertainty. Having a secondary supplier will also contribute to prevent supply chain disruptions.
Consider CMO geography: For products intended for distribution in the United States, a US-based manufacturer can help prevent issues due to tariffs or import duties.
Collaborate on material forecasting: To guarantee raw material availability, provide frequent projections with the CMO. For example, to get necessary components, communicate your forecasts months in advance if you expect seasonal spikes in demand for diagnostic kits.
Improve inventory management: To keep an eye on stock levels in real time, use inventory tracking systems that are connected to the CMO’s procedures and set automated warnings for reorder points.

Planning for Scalability and Flexibility

Rapid changes in market conditions necessitate production that is both scalable and flexible. Working with a CMO that is capable of modular manufacturing helps ensure that you can react effectively to changes in demand.

Choose a CMO with adaptable production lines: Provide projections for scale up or scale down and assess the CMO downtime to evaluate the CMO’s modular manufacturing capabilities. Choose a CMO that can quickly scale up or down production levels in response to market demands.
Discuss scalability and tired pricing models: Make sure your contract contains clauses that can adapt to changing production volumes and that clearly outline the cost structures for each tier. Regardless of changes in the market, this assists financial predictability.
Assess the capacity: Evaluate whether the CMO has the infrastructure and equipment to support future growth. Factor in lead times for additional equipment or facility expansions.
Technology adaptation: To keep a competitive edge, make sure the CMO can swiftly embrace and adapt new tools or techniques.
Keep an emergency scale-up plan: Create backup plans for sudden spikes in output, like during a pandemic or a significant product launch. Consider secondary manufacturing sites and for your primary site have the CMO pre-qualify more employees.

Building a Collaborative Partnership

The foundation of a successfully scaling up IVD manufacturing is establishing openness, trust and common goals with your CMO.

Create consistent channels of communication: Set up regular team meetings to discuss supply chain and production updates, exchange critical information, and review documentation.
Involve both teams in planning: To streamline priorities and resources, include members from your organization and the CMO in planning discussions. As an example, engage the CMO’s engineers in conversations on reagent dispensing equipment optimization, rather than just the project manager.
Encourage a feedback loop: Motivate the CMO to offer proactive input and feedback on methods to cut expenses or increase efficiency. Acknowledge and implement their recommendations to strengthen a culture of cooperation.

Conclusion

Scaling up IVD manufacturing is challenging but can be made significantly faster and easier by engaging a CMO. You can meet market needs without sacrificing quality by concentrating on strategic alliances, strong quality assurance, regulatory compliance, and adaptable supply chain management.

Choose From a Wide Selection of Argonaut IVD Manufacturing Services

Full service contract manufacturing for IVD, POCT and RUO
Complete product cycle management
Complete supply chain management for all your assay suppliers and vendors
Product configurations, formulations, assay development, kitting
Ability to fill cartridges, devices, chips, etc.
Controlled temperature storage
Pick-pack-ship, drop-ship, pallet shipping available
Lyophilization services– cake, powder, beads, dots

Why Chose Argonaut when you are Scaling Up IVD Manufacturing

Top IVD Manufacturers Attribute

Why Argonaut

Robust Technical Transfer

Argonaut has specialized services for technical transfer of IVD diagnostic products, with years of experience.

Early & Late Supply Chain Support

We manufacture in all commercial phases: from pre-launch engineering builds to flexible on-demand production.

Scalable Solutions

Our teams can hand-fill when white-glove attention is needed, or we can use our robotic systems as scale demands increase.

Quality

Argonaut adheres to the highest quality standards including: ISO13485:2016 and cGMP

Regulatory Expertise

Argonaut has been inspected by the FDA and we support a wide range of products under 21 CFR 820.

Transparency

Argonaut promises to suggest alternative approaches to provide you a range of choices.

Lyophilization

Argonaut is a recognized leader in lyophilization with a wide service selection including cakes, powders, beads, and dots.