Outsourcing pharmaceutical manufacturing is becoming essential to remain competitive in the industry. The rise of small-batch personalized medicines and “virtual companies” are key drivers to retain flexible, external manufacturing capabilities. With various competing Contract Development and Manufacturing Organizations (CDMOs) available, selecting the right CDMO partner for your business can be difficult. You should look for a CDMO that:
- Uses state-of-the-art equipment and can meet your manufacturing capacity needs.
- Adheres to international regulatory standards.
- Works flexibly with you as a partner.
How can you differentiate between an optimal CDMO partner and a pitfall? Here are the three key areas to consider when selecting your drug product manufacturing partner.
1. Capabilities, Capacity, and Technology
With drug manufacturing outsourcing penetration expected to soar from 30% in 2018 to 40% in 2020, CDMO capacity will be in greater demand. As personalized medicine drives more discovery-based and virtual companies without in-house capabilities to come online, demand for API manufacturing and fill-finish activity will continue to increase. Limited CDMO capacity is already a chief complaint among pharmaceutical board members that outsource their manufacturing.
Be sure to select a drug product manufacturing partner that has capacity to support your projects not only now, but also in the future. CDMOs with equipment built for fast turnover will have greater flexibility and production capacity. This need for availability extends beyond just production; look for a CDMO with an efficient tech transfer process and the ability to support your quality control testing needs.
Not all fill-finish lines are created equal. While drug product fill-finish has historically been resistant to changes in technology and regulation, several new trends are taking hold. Manufacturers are now moving to reduce contamination, increase product yield, and improve their flexibility with technological advances. These trends are driven by rising drug quantity and diversity, coupled with an increase in high-value biologics.
Give priority to drug product manufacturing partners that utilize these new approaches and equipment. Single-use technology offers many advantages, including reducing turnaround times and eliminating cleaning deficiency risk. CDMOs working with single-use will have better flexibility of their capacity as a result. Newer equipment offers high-yield filling, avoiding expensive loss of your product. Automation strategy is perhaps the most important technology factor to evaluate by. Automation within an isolator system protects against the primary source of contamination; humans. Some regulatory standards now require this setup in order to be compliant.
Building a New Fill-Finish Line: Argonaut as a CDMO Case Study. When the Argonaut team set out to design our drug product manufacturing program, state-of-the-art technology was key. Market trends indicate pharmaceutical manufacturers moving away from hand fills and washed components towards isolators and single-use technology; supporting the concept known as the Facility of the Future. We chose to partner with top equipment manufacturer Bausch + Ströbel and selected a VarioSys line housed within SKAN isolators. The line uses nested ready-to-fill components and minimizes glass-to-glass contact, which eliminates vial cleaning steps and reduces the risk of glass particulates. Bausch + Ströbel’s ADVANCEDfill technology offers high-yield filling that avoids product loss. By making strategic equipment selections, you can protect against risks and improve your yield.
Regulatory compliance is a top factor in selecting a CDMO, with 72% of those surveyed ranking it as important. The pharmaceutical regulatory environment is constantly evolving, and it is critical that your drug product manufacturing partner keeps up. A recent example of a challenge in the field is the European Falsified Medicines Directive (EU FMD) that took effect in February 2019. Many CDMOs scrambled to acquire necessary equipment, coordinate internal processes, and onboard customers. Some even chose to drop certain capabilities in order to remain in compliance.
Being out of compliance is avoidable and can be an expensive misstep for your company. This is especially a concern for smaller, discovery-based companies without their own regulatory affairs departments. A strong drug product manufacturing partner will stay ahead of impending policy changes and keep you compliant. As part of your selection process, look for a CDMO that treats regulatory and quality systems as a priority.
Look for a partner, not just a provider. Working with a strong CDMO partner can help protect against numerous common issues. A flexible manufacturing partner works with you to find production capacity, and may co-invest strategically to bring needed support capabilities in-house. Working closely with your CDMO also enables better communication and preparedness for new regulatory challenges.
As the number of pharmaceutical companies grows and drug batch sizes continue to shrink, demand for drug product manufacturing outsourcing will expand. With demand outstripping CDMO capacity, selecting the right long-term ally is critical. Focus on capabilities, capacities, regulatory controls, and accessing the newest technology. Finally, set yourself up for success by choosing a partner, not a provider.
Interested in finding the right CDMO partner? Contact Argonaut to learn how we can support your manufacturing needs.