Outsourcing to a contract development and manufacturing organization (CDMO) can be critical to ensuring success for many early stage cell and gene therapy (CGT) companies with limited resources, but finding the right partner can often seem daunting in an increasingly crowded field.

When evaluating CDMOs, it’s important to look beyond the basic attributes to the unique capabilities that will serve your organization best. And since outsourcing decisions are driven primarily by gaining access to specialized equipment and expertise without major capital investment, these are the factors to pay particular attention to when parsing CDMO claims.

A truly exceptional partner will deliver strong value on the basics while also galvanizing your clinical and business success:

Timeline

Time is always in short supply and, in the CGT industry in particular, timeline pressure is a constant. A CDMO that clearly communicates around timelines and is able to work flexibly with you to stay on track will help you maximize your investment faster while staying ahead of competitors. Available clean room space is also a critical factor, as many facilities are booked years in advance. Inquiring early about clean room wait times, even in large facilities, is a must.

Quality

CDMOs need to maintain and exceed standards to ensure the quality of their services, and doing so, in the still-evolving CGT space, poses an extra degree of challenge. Working with a company that is in compliance with global current Good Manufacturing Practices (GMP) for CGT is critical, as is ensuring that a phase-appropriate quality management system (QMS) approach is used to maintain flexibility in early development to contain costs. 

Communication

Biopharmaceutical companies and CDMOs that can form productive lasting partnerships by sharing a communication style and similar values maximize the chances of project success. Timely and transparent dialogue, and effective project management, are essential for collaboration to succeed and for both parties to feel that the relationship is mutually beneficial.

Cutting-Edge Technology

For start-up companies trying to develop innovative CGTs in a rapidly evolving field, having access to a CDMO’s specialized technologies and state-of-the-art equipment can be a critical decision point when charting the path towards commercialization. While many CDMOs will feature standard equipment and capabilities, only a few will offer the kinds of specialized technology and services that will truly fit your current and future needs.

CDMO’s that invest heavily in scale-up/-out infrastructure for up- and down-stream processing, automation and process closure methodologies and analytics discovery/development should be on your short list. These capabilities are typically critical for GMP-compliant process development and process characterization that moves beyond pre-clinical and early phase production towards fit-for-purpose commercial manufacturing of therapeutic products. Additionally, organizations that can provide regulatory and commercialization guidance are a cut above the rest and will help ensure your success.

Look for a CDMO that has a history of investment in scalable manufacturing platforms, strong technology partnerships and a demonstrated commitment to staying at the leading edge of the field.

Expertise

One of the greatest benefits of working with a CDMO is having access to scientists outside of your team with experience, knowledge and specialized capabilities. While many CDMOs will employ a few technical experts in select areas such as bioprocess engineering or cell biology, only a few will offer access to the broad spectrum of expertise required in cell and gene therapy process engineering.

CDMOs that employ a wide variety of highly qualified experts, especially in stem cell biology, immunobiology, virology and all of the associated analytics are less common, yet these capabilities are often essential to delivering an integrated approach to process design, development and characterization. Additionally, organizations that can provide smooth technology transfer from process development to GMP manufacturing lead the pack in delivering a more consistent on-time, on-target outcome.

Look for a CDMO that has built a solid reputation for leading-edge innovation as value-added process development and definition can significantly lower the lifetime costs of your commercialization pathway.

Flexibility

For early stage companies, it is critical that a CDMO offers a flexible approach to process development and manufacturing. While larger CDMOs enjoy high levels of market recognition, their heavily siloed functions and processes can impose undue burdens on smaller, earlier stage companies that need a more tailored approach.

CDMOs that can work with you in close collaboration will allow you to better navigate the unexpected, which in a field like CGT is par for the course. The right CDMO will become an extension of your team and, by seamlessly adding their expertise to yours, will speed your path to the clinic.

Look for a CDMO with a track record of high customer satisfaction and repeat business, and assess the comfort and confidence of your team in early technical discussions with their counterparts.

To learn more about how CCRM’s CDMO services can support your early stage cell or gene therapy product, please contact cdmo@ccrm.ca.

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