www.biopharminternational.com April 2019 BioPharm International eBook 11
Outsourcing Resources Chemistry, Manufacturing, and Controls
Table II (continued). Contract development and manufacturing organization (CDMO)'s service and sponsor's expectation.
rev iew d at a, c he c k m i lestones,
discuss unforeseen technical or
logistics challenges, seek a path
for wa rd to ove rcome t he c ha l-
lenges, and re-adjust timelines as
necessary.
CONCLUSION
In t he c ur rent biopha r maceut i-
cal landscape, the development
b u s i n e s s m o d e l i s c o n s t a nt l y
t r a n s f o r m i n g , a n d n e w d r u g
modalities are blooming. Biotech
c omp a n ie s, p a r t ic u l a rly sm a l l
c o m p a n i e s , n e e d t o b e n i m -
ble to su st a i n t he m se lve s a nd
thrive in this competitive envi-
ronment. Working with CDMOs
for accelerated development of
dr ug candidates from discovery
to clinical trials has become an
accept able mo de l for b u si ne ss
cont inuit y. T he jour ney of t he
partnership with CDMOs is full
of challenges, f r ustrations, sur-
pr i s e s, ac h ieve me nt s, a nd s uc-
cess together.
REFERENCES
1. P. Seymour, et al., BioProcess Int. 4 (S5)
26–29 (2006).
2. R. Ding and H. Kumar, "Strategic
Collaboration with CMOs for Accelerated
IND Filing," presentation at the CBI Speed
to IND for Biologics (San Francisco, CA,
2018).
3. K. Dhanasekharan, K. Humbard, B.
Kester, et al., "Emerging Technology
Trends in Biologics Development,"
bioprocessintl.com, Oct. 14, 2016, https://
bioprocessintl.com/manufacturing/
manufacturing-contract-services/
emerging-technology-trends-in-biologics-
development-a-contract-development-and-
manufacturing-perspective/.
4. P. Stockbridge, "Biopharmaceutical
Quality Assurance," bioprocessintl.com,
Nov. 1, 2008, https://bioprocessintl.
com/2008/biopharmaceutical-quality-
assurance-184041/.
5. D. Gupta, G.N. Prashanth, and S. Lodha,
"A CMO Perspective on Quality Challenges
for Biopharmaceuticals," bioprocessintl.
com, Oct. 1, 2013, https://bioprocessintl.
com/author/authoracct201310-3bpi-com/.
BP
CDMO's
service
Sponsor's expectation
Manufacturing 1. Does CDMO have an adequate number of qualified, trained, and experienced employees?
2. Does CDMO provide strict cGMP training for operators?
3. Does CDMO violate cGMP production (i.e., legibilit y, data integrit y, cGMP compliance)?
4. Does CDMO strictly use validated equipment and facilit y for manufacturing?
5. Does CDMO have flexible scheduling?
6. Does CDMO facility do multi-client ser vice? If yes, what is the procedure to mitigate cross-contamination between projects?
7. What is the average deviation rate per GMP batch production?
8. Does CDMO investigate deviation root cause analysis (RCA) thoroughly? If yes, which investigation methods (i.e.,
brainstorming, 5 whys, fishbone diagram)?
9. Does CDMO jump to conclusions in their haste to find a RCA of an incident?
10. Does CDMO allow a RCA conclusion to drive data or allow data to drive?
11. Does CDMO address RCA adequately, properly, and suf ficiently to prevent similar deviation reoccurrence?
CDMO with
multi-
geographic
locations
1. Does CDMO have same equipment from dif ferent sites (i.e., pH/conductivit y meters, SE–HPLC, depth filter holder)?
2. Does CDMO use same format of documentation from different sites (i.e., repor t, study protocol, technology transfer protocol,
and master batch records)?
3. Does CDMO have matured scale-up/scale-down model between process development, pilot, and manufacturing
4. Does sponsor have burden and concern for cost and time for travel?
5. Does sponsor have concerns about the qualit y of communication and job per formance at dif ferent sites?
6. How can sponsors monitor the level of integration and communication across sites from CDMO?
7. How long has the multi-site model been in practice and how has it been optimized for ef ficiency, harmonization, and cross-site
communications from CDMO?
8. Are suppor t ser vices like analy tical development /qualit y control ef fectively replicated across sites such that work may be
ef ficiently transferred from one site to another?
Working with CDMOs
for accelerated
development of drug
candidates from
discovery to clinical
trials has become an
acceptable model for
business continuity.
