BioPharm

10 BioPharm International eBook April 2019 www.biopharminternational.com Outsourcing Resources Chemistry, Manufacturing, and Controls CDMO's service Sponsor's expectation Capacit y, capabilit y, and client ser vice 1. Does CDMO have experience (both early and late stage) for mammalian cell culture and/or microbial fermentation ser vice? 2. Does CDMO have the appropriate manufacturing scale that meets the biotech needs? 3. For potent monoclonal antibodies (mAbs), can CDMO leverage ver y small scale (200 –1000L) for Phase I, and then transfer later to large scale once they have demonstrated safet y and possible Phase II proof-of-concept in clinic? 4. Does CDMO have exper tise at all levels from all functional depar tments for mAb and/or non-mAb product discover y, process development, manufacturing, and current regulator y knowledge? 5. Does CDMO have knowledge to suppor t technical decisions well ahead of filing time in order to ensure the correct /strategically sound path taken? 6. Does CDMO have qualified, experienced, and professional team members on your project? 7. Do CDMO core members have established and successful track-records with respect to process development, assay development, manufacturing operational excellence, and qualit y control and assurance? 8. Does CDMO have platform technologies for process development (cell-line development, cell culture, purification, formulation, and drug substance [DS]/drug product [DP] production), analy tical methods, hardware, facilit y, and automation? 9. Does CDMO provide competitive and realistic timeline and pricing for biologic drug development and manufacturing without compromising deliverables, product qualit y, and safet y? 10. Does CDMO have high throughput equipment and facilit y (i.e., ambr 250, TECAN) to meet sponsor's needs? 11. Does CDMO intend to make capital investments to upgrade its old or legacy system (i.e., size exclusion–high-per formance liquid chromatography [SE–HPLC] for continuous process monitoring)? 12. Does CDMO provide ser vice for both DS manufacturing and DP fill/ finish? If DS and DP manufacturing sites are at dif ferent locations, what is the logistics plan to align two activities between two sites? 13. Does CDMO have a good reputation of ser vice in on-time deliverables, qualit y, flexibilit y, and responsiveness? 14. What is the cancellation policy of the contract due to unforeseen issues? 15. What is the CDMO's current scope of ser vice of ferings, and does this align with your needed scope? 16. Does CDMO focus on client's project qualit y, timelines, and unique needs? 17. Does CDMO provide end-to-end ser vices including product and process development, assay development and validation, product release and stabilit y, sterile fill, viral clearance validation, cell-bank generation and characterization, process characterization, and validation? 18. Does CDMO provide solutions to prevent and resolve project issues in a proactive, timely, and responsive manner? 19. Does CDMO overpromise for the contract but create potential deliverables missed during the process development and manufacturing? 20. Does CDMO have a strong, flexible, and responsive management team to facilitate timely decisions and foster communications between CDMO and customers? 21. Does CDMO have response timeframes? If yes, what level of technical staf f are responsible for communication? Price 1. Does selected CDMO of fer competitive pricing? 2. Does CDMO have an intention to create a change order even with a minor change in scope of work? 3. Does CDMO of fer a discount ser vice pricing if multiple projects are provided? 4. Does CDMO provide strategies from process development to manufacturing for cost-of-goods reduction? 5. Does CDMO share basic pricing (i.e., full-time employee week, GMP suit utilization, water for injection)? Qualit y system/ regulator y suppor t 1. Does CDMO have a robust qualit y system in place for internal, regulator y, and client's expectation? 2. Does CDMO qualit y system maintain the same level per FDA, European Medicines Agency, and other regulator y agencies requirement? 3. Does CDMO have the same qualit y system (i.e., harmonized standard operating procedures) if it has multiple sites? 4. Does CDMO qualit y system ensure DS/ DP safet y, qualit y, ef ficacy, strength, reliabilit y, and durabilit y? 5. Does CDMO pass regular regulator y inspections? 6. Does CDMO have historical 483s and warning letters from regulatory agencies, and is it willing to provide redacted copies? 7. Does CDMO follow strictly practices for GMP manufacturing operation and good documentation practices (GDP) documentation? 8. How to handle confidentialit y from CDMO? Table II. Contract development and manufacturing organization (CDMO)'s service and sponsor's expectation.

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