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36 BioPharm International ® Manufacturing and Facilities 2022 eBook www.biopharminternational.com OUTSOURCING Many product developers today are looking to enter into a partnership with a CDMO, and not just a trans- actional relationship. There is a profound difference between these two approaches: fee for service versus a partnership based on trust, understanding, and shared view that is intended to run over a longer term (whether for one product or several products based on similar technology). The outcomes of these two models are not always the same for companies who work with large or complex products (such as gene therapies), as serious issues can result in a need to change the manufacturing site, which is a costly endeavor that can create signifi- cant delays to overall product development programs. As such, many product developers assess potential CDMOs over a longer-term horizon, even though the initial phase of work may only entail early process de- velopment or the generation of material for pre-clinical evaluation. Oftentimes, the evaluation process, even for early phase activities, can include an assessment of how the program can evolve over different stages of development, three to five years into the future. The following questions are often raised to CDMOs for early-stage programs (and lead to long-term success for product development): • How do you approach process characterization and process validation? • Can you support us with regulator y dossier writing? • What prior experience do you have in doing this? Lastly, one key advantage of working with CDMOs that merits highlighting is that they have generally gained a lot of experience across multiple different projects. In many cases, they have seen and learned things in previous projects that can be of benefit to your project (while maintaining client confidential- ity and respecting IP). It's the type of experience that other companies may not yet have gained in-house, but it may be key to the success of a program. This usually has many benefits when evaluating concerns around control and costs, which are both related to experience and capabilities. In summary, choosing whether to internally develop and manufacture biopharmaceutical products or to out- source these activities is a complex and high-stakes de- cision, which can have a profound impact on the success of a product development program. Many factors should be considered in such an evaluation; but in many cases, this comes down to key considerations around exper- tise, capacity/technology, and economics. CGT products raise additional dilemmas. Different situations, such as internal capacities and capabilities, may direct compa- nies toward different choices, either in the short or long term. If the decision is to outsource, a quality-focused, partnership-based approach is critical to future success given the complexity of the products and the technolog- ical and regulatory evolution of the CGT sector. References 1. H. Kurata et al., Front. Bioeng. Biotechnol., DOI:10.3389/ fbioe.2022.841420 (March 2022). 2. Pharmaceutical Online, "Choosing A CDMO: If You Can't Answer 'Yes' to These 3 Questions, Walk Away," www.pharmaceuticalonline.com, accessed Aug. 1, 2022. 3. Outsourced Pharma, "Selecting A CDMO: Strategies t o E n s u r e a S u c c e s s f u l P a r t n e r s h i p," w w w. outsourcedpharma.com (Nov. 14, 2017). 4. American Pharmaceutical Review, "Risk Minimization T h r o u g h C a r e f u l C d m o S e l e c t i o n ," w w w. americanpharmaceuticalreview.com (Sept. 29, 2015). 5. Bioprocess Online, "CMC and Quality Considerations When Engaging Your CDMO," www.bioprocessonline. com, accessed Aug. 1, 2022. 6. Ph a r m ace ut ic a l O n l i ne, " B e t t i n g t he Hou s e: CDMO Selec t ion for Emerg i ng Pha r ma," w w w. pharmaceuticalonline.com, accessed Aug. 1, 2022. 7. T he Medicine Ma ker, "So, You Wa nt to Become a CDMO," w w w.themedicinemaker.com, accessed Aug. 1, 2022. 8. BioProcess International, "Developing Advanced- Therapy Products Through Global CDMOs," www. bioprocessintl.com, accessed Aug. 1, 2022. 9. B i o P r o c e s s I n t e r n a t i o n a l , " W i l l I n - H o u s e Manufacturing Capabilities Give Cell and Gene Therapy Developers Competitive Advantages?", www. bioprocessintl.com, accessed Aug. 1, 2022. 10. J. Lynch Lambert, "Regenerative Medicine: New Paradigms," Cell & Gene T herapy Insights online, DOI:10.18609/cgti.2022.018 (Feb. 1, 2022). 11. Alliance for Regenerative Medicine, Regenerative Medicine: Disrupting the Status Quo (2021 annual report). ■ Entegris.................................................................................................... 25 Evotec SE ................................................................................................. 13 G-CON Manufacturing ............................................................................. 5 WuXi Biologics .......................................................................................... 3 Ad Index COMPANY PAGE