www.biopharminternational.com Quality and Regulatory Sourcebook eBook March 2022 BioPharm International 39
MOVING FORWARD WITH CM
BioPharm: What types of regulatory
guidance would be helpful in expand-
ing use of CM?
Ko k a i - K u n ( U S P ) : T h e d r a f t
IC H g u i d e l i n e Q1 3 C o n t i n u o u s
Manufacturing of Drug Substances and
Drug Products published last summer
is certainly a good start, but addi-
tional guidance and regulatory strat-
egies are needed to facilitate adoption
of BCM. ICH Q12 currently provides
a framework to facilitate the manage-
ment of post-approval changes more
predictably and eff iciently across the
product l ifec ycle (2). Streaml ined
regulator y pathways to allow adap-
tation of approved batch processes
into BCM processes resulting in a
comparable product would also facil-
itate adoption of this technology for
existing products.
BioPharm: What types of training
are needed?
Kokai-Kun (USP): W hile there is
less d i rec t hu ma n involvement in
BCM as compared with batch man-
ufacturing, there is need for skilled
w or k e r s w ho c a n d e v e l o p B C M
processes, keep them running, and
troubleshoot problems. In terms of
process development, BCM brings
toget her un ique sets of sk i l ls not
norma l ly associated w ith biologics
manufact uring, including soft ware
development and data analytics. Just
getting a diverse team of specialists
to speak the same language and com-
municate effectively within the team
can be challenging. There are a lot
more data management requirements
in BCM, and integrating these into
the developmental process and then
implementing them in a current good
manufacturing practice manufactur-
ing facility can be challenging.
BioPharm: What do you anticipate
for the next steps at USP?
Ko ka i - Ku n (USP): D e v e l o p i n g
physical or performance standards for
these technologies will require time;
however, USP is actively working on
guidance and documentary standards
to assist industry, and several General
Chapters are already available in the
United States Pharmacopeia-National
Formulary. For example, USP recently
publ ished for com ment prop osed
chapter <1220> Analytical Procedure
Life Cycle (3). The chapter demon-
strates the suitability of an analytical
method over a product's entire life-
cycle, including development, valida-
tion, and continuous verification and
may be useful for adoption of new
technologies. Besides standards, there
is also a need for educational mate-
rial for stakeholders to understand
the benefits of these technologies and
how to best implement and review
their performance.
REFERENCES
1. ICH, Continuous Manufacturing
of Drug Substances and Drug
Products Q13, Draft Version,
Step 2 ( July 27, 2021).
2. ICH, Technical and Regulatory
Considerations for Pharmaceutical
Product Lifecycle Management
Q12 (Nov. 20, 2019).
3. USP, Proposed Chapter
<1220>, "Analytical Procedure
Life Cycle," Pharmacopeial
Forum 46 (5). BP
Quality and Regulatory Sourcebook Compendial Compliance
Avid Bioservices ...............................................19
Baxter BioPharma Solutions ...........................23
Entegris ................................................................3
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"Streamlined
regulatory pathways
to allow adaptation
of approved batch
processes ... would
facilitate adoption."
—John Kokai-Kun,
USP
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