In recent years, complex and high-value biologics products, such as monoclonal and multispecific antibodies, exosomes, and bioconjugates, have made significant strides, and biopharmaceutical drug developers are increasingly relying on contract development and manufacturing organizations (CDMOs) to provide the specialized knowledge, expertise, and science-based technology required to accelerate the process development, scale-up, and GMP manufacturing of these products. To this end, careful selection of a CDMO is one of the most critical decisions made by companies/sponsors with limited internal resources dedicated to process development, manufacturing, testing, and control of complex biopharmaceutical products for early, late, and ultimately commercial use. Learn more about GBI’s Clinical & Commercial Manufacturing Capabilities!
The quest to identify and select a CDMO generally must meet the following criteria:
- Experience — in process development, GMP manufacturing, and IND-enabling activities for monoclonal antibodies (mAbs), recombinant proteins, bioconjugates, and other complex biologics.
- End-to-end capabilities — GMP cell banking, upstream, downstream, and bioconjugation process development and manufacturing, aseptic fill/finish, protein characterization, and RA/QA/QC support for phase I to III clinical study materials and commercial manufacturing.
- Quality of the project proposal, project management, and communication capabilities ––managing client’s expectations through the generation of a unique and custom proposal describing project details, cost, and timelines. The ability to communicate effectively throughout the project life cycle will have a profound influence on the overall outcome of the project. The communication style and culture of the CDMO selected must align with the sponsor’s to ensure a productive and efficient working relationship.
- Partnership — Ability of the CDMO to demonstrate effective partnership and collaboration with the project sponsor. This is usually achieved through flexibility; ability to anticipate and address technical and regulatory issues, bottlenecks and production capacity; speed to materials generation for clinical trials; end-to-end product quality at any scale; and the ability to de-risk the manufacturing process.
- Trust — Even if trust is a subjective criterion, we remain human. Companies should consider, above all, the CDMO that gives you confidence through performing objective audits and engagement with the personnel who will be responsible for the manufacture of their therapeutic or diagnostic product.
- CDMO location — Local or international and single or multiple CDMO sites may be a consideration for prospective clients in ultimately selecting a CDMO.
Summary
Uncertainties and risks always exist when choosing a CDMO, as discussed above. In the current climate of global mergers and acquisitions, the sponsor needs to establish a strategic partnership and cultivate a mutually beneficial and productive relationship with the chosen CDMO. It is imperative for the CDMO to establish and execute on efficient cost estimates and timelines, capabilities, and product quality. End-to-end capabilities during the generation of the biologic drug substance and drug product must be considered while ensuring that the chosen CDMO can appropriately address phase-appropriate requirements and challenges.
GBI as a strategic guidance biologics CDMO
Having completed over 500 projects for more than 150 clients and 50+ successfully IND filings, GBI, based in the same facility in Plantation, Florida since 1992, has met and exceeded the criteria indicated above for the selection of a CDMO. This includes vast experience and knowledge in quality, project management, regulatory, process development, and manufacturing requirements for biologic drug substances and drug products, such as antibodies, recombinant proteins, bioconjugates, and other complex biologics. Our team of experts understands the challenges and the need for speed, flexibility, and nimbleness for meeting important milestones and can provide you with the strategic guidance and flexible solutions that are custom-built based on our comprehensive experience, successful track record, and capabilities from preclinical, early to late stage, and ultimately commercial manufacturing.
Click here to view our previously published article titled “Leveraging Experience to Reduce Timelines for IND-Enabling Activities” by Muctarr Sesay, GBI’s CSO, and Andrew Majdoch, GBI’s AVP of Technical Operations.
Useful checklist to identify potential CDMO partners:
- Extensive experience/background:
- Experience and knowledge with biologics manufacturing (e.g., mAbs, recombinant proteins, fusion proteins, bioconjugation, sterile fill/finish)
- Smooth tech transfer of processes and analytical methods from the client to the CDMO
- Robust and well-established quality system
- Flexible and established manufacturing platforms with robust analytical characterization SOPs and protocols
- RA/QA/QC experience:
- Knowledgeable with the latest regulatory standards for the international and multi-regional experience to support key regions, such as the United States, Canada, Europe, and Australia
- Experienced quality and regulatory team with expertise in regulatory authority guidelines and technical documents, including CMC regulatory services for clinical and commercial manufacturing and life cycle maintenance
- Early development capabilities:
- Ability to develop scalable, economical, and compliant processes in a timely manner using the CDMO’s robust platform manufacturing processes
- Transparency and flexibility between the CDMO and the client through experienced project management team
- Established flexibility, speed, accuracy, and global supply chain strategy in the execution of tech transfers
- End-to-end manufacturing capabilities of the drug substance and drug product
- Late stage and commercial manufacturing:
- Strong failure mode and effect analysis (FMEA) risk-management and risk-mitigation strategy
- Established successful long-term business strategy between CDMO and the client
- Expertise with design of experiments, scale-down models, process characterization and control strategy, process performance qualification manufacturing, and other Biologics License Application (BLA)-enabling capabilities
