BioPharm

www.biopharminternational.com April 2019 BioPharm International eBook 7 Outsourcing Resources Chemistry, Manufacturing, and Controls and facility at early phase drug development and clinical trials (1). Fi g u r e 1 illust rates t hat bio - pharmaceutical companies have to spend a tremendous amount of money (more than $1 billion for R& D, process development, m a n u f a c t u r i n g , a n d c l i n i c a l trials) and time (more than 10 yea r s), a nd contend w it h h igh r isk s ( less t han 10 % successf ul rate), to bring a biological drug candidate from discovery to com- mercialization (2). Using CDMO services...particularly for a start-up biotech company, is one of the best options. To reduce cost and increase the success rate of an accelerated drug development program, sponsors should apply a CMC due diligence process prior to and during drug development, manufacturing, clin- ical trials, and commercialization (Figure 2). Using CDMO services (i.e., capacity and capability), par- ticularly for a start-up biotech com- pany, is one of the best options (3). CDMO SELECTION How does one selec t t he r ight CDMO and form a trustful and productive partnership? There are a number of CDMOs, small and large, available in the market. Tab le I lists the generic p r o c e d u r e o f C D M O s e l e c - t ion ba s e d on t he e x p e r ie nc e of one company, A napt ysBio, a clinical-stage antibody develop - ment company. During the selec- tion, a matrix checklist should be prepared that shows a CDMO's service and the sponsor's expec- t a t i o n ( Ta b l e I I). L i s t i n g t h e CDMO's service should reflect its service speed, expertise, experi- ence, equ ipment, fac i l it y, f le x- ibility, price, capability, capacity, reputation, quality system, com- mu n ic at io n s t y l e, ge o g r ap h ic Figure 2. Chemistry, manufacturing, and control (CMC) due diligence process for accelerated drug development. RCB/ MCB is research cell bank/master cell bank. mAb is monoclonal antibody. IND is investigational new drug. DS/DP is drug substance/drug product. SUB is single-use bioreactor. IP is intellectual property. Figure 3. Chemistry, manufacturing, and control considerations for contract development and manufacturing organization (CDMO) selection.

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