PharmTech.com Bio/Pharma Outsourcing Innovation eBook February 2024 Pharmaceutical Technology
®
25
Qualit
y
Summary
By conducting a thorough in-person audit of a CDMO
and asking the right questions for the right information
during that process, a sponsor company—even a small
biotech—can gain the confidence that a contract man-
ufacturer truly has the necessary quality systems and
culture to ensure product quality, protect the sponsor's
project, and most importantly, ensure patient safety.
Ensuring that a CDMO has an unwavering commit-
ment to quality will require some time and effort, but
this is an appropriate use of resources that will pay off
in the long run. Paying insufficient attention to auditing
CDMO quality brings the risk of choosing a CDMO part-
ner that could cause your company significant problems
and even catastrophic loss. A popular adage, frequently
credited to Benjamin Franklin, captures this truth: "The
bitterness of poor quality remains long after the sweet-
ness of low price is forgotten." Quality is not cheap, but
the rewards for ensuring quality in your biopharmaceu-
tical products will benefit your company for a long time.
References
1. FDA. Compliance Program, Chapter 56—Drug Qual-
ity Assurance, Subject: Drug Manufacturing Inspec-
tions. https://www.fda.gov/media/75167/download
2. US Code of Federal Regulations (CFR), Title 21, Part 211.25,
Personnel qualifications. https://www.ecfr.gov/cur-
rent/title-21/chapter-I/subchapter-C/part-211/sub-
part-B/section-211.25
3. US Code of Federal Regulations (CFR), Title 21, Part
211.22(a), Responsibilities of quality control unit. (US
Government Printing Office, Washington, D.C, 2023);
https://www.ecfr.gov/current/title-21/chapter-I/sub-
chapter-C/part-211/subpart-B/section-211.22
4. ICH. Q10, Pharmaceutical Quality System, Step 4 ver-
sion (ICH, 2008). https://database.ich.org/sites/de-
fault/files/Q10%20Guideline.pdf
5. EU Clinical Trials Reg ulation, Reg ulation (EU)
No 536/2014 (2014). https://eur-lex.europa.eu/eli/
reg/2014/536/oj/eng
6. EC. Annex 13, Investigational Medicinal Products.
EudraLex, Volume 4, Good Manufacturing Practice
(GMP) guidelines, https://health.ec.europa.eu/sys-
tem/files/2016-11/2009_06_annex13_0.pdf
7. EC. Detailed Commission Guideline on the Good Manu-
facturing Practice for Investigational Medicinal Products
(2017). https://health.ec.europa.eu/system/files/2017-
12/guideline_adopted_1_en_act_part1_v3_0.pdf
8. EC. Chapter 7, Outsourced Activities. EudraLex, Vol-
ume 4, Good Manufacturing Practice (GMP) guide-
lines.. https://health.ec.europa.eu/system/files/2016-
11/vol4-chap7_2012-06_en_0.pdf. ■
Accelerating Biopharma Development and
Manufacturing through CDMOs and CGT
The biopharmaceutical industry has seen a lot of change in recent
years, between new collaborations with supplier and contract devel-
opment and manufacturing organizations (CDMOs) and accelerated
drug delivery times. In this episode of Drug Digest, Pharmaceutical
Technology
®
talks with Anil Kane from Thermo Fisher Scientific and
Jason C. Foster of Health Equity Consulting about what happens in
the manufacturing space from a contract development and manu-
facturing organization and a cell/gene therapy perspective.
About Drug Digest
Drug Digest is a tech talk video series with the Pharmaceutical Tech-
nology editors. Our editors interview industry experts to discuss the
emerging opportunities, obstacles, and advances in the pharmaceu-
tical and biopharmaceutical industry for the research, development,
formulation, analysis, upstream and downstream processing, manu-
facturing, supply chain, and packaging of drug products.
Anil Kane
has more than 25 years of experience in the
science and business of taking molecules
through the entire drug development process
and currently serves as the global head of
technical and scientific affairs, pharma ser-
vices, Thermo Fisher Scientific. His extensive
knowledge spans early-stage development to
scale-up and commercial manufacturing and
includes technical transfers between global
sites and drug life cycle management.
Jason C. Foster
has held leading roles in consulting, healthcare
and technology companies for nearly 20 years
in the US, UK and Europe. He also serves as
a Non-Executive Director of London-based
healthtech start-ups gripAble and Credentially,
as well as Auxita Pty, an Australian healthcare
data platform and hystrix medical AG, a Swiss
B2B marketplace for medical products. As the
Managing Director of Health Equity Consulting,
he has advised private equity & venture capital
funds, family offices, accelerators and
healthTech start-ups.
