8 BioPharm International
®
Manufacturing and Facilities eBook 2023 www.biopharminternational.com
T
he demand for rapid timelines from drug
development to commercialization is
rising. Expediting timelines in develop-
ment and manufacturing is critical for
drug manufacturers to ensure vital medicines
rapidly reach the patients who need them. Bio-
logic manufacturing has seen numerous devel-
opments that have helped reduce production
process timelines, with the industry striving to
standardize and simplify manufacturing processes.
By developing comprehensive strategies that in-
clude deep knowledge of the regulatory arena, spe-
cialized contract development and manufacturing
organizations (CDMOs) can streamline workf lows,
reduce production costs, and increase ef f icienc y.
The reliance of biopharma companies on CDMOs
to provide these benefits is ref lected in the CDMO
outsourcing market, which is predicted to expand
at a compound annual growth rate of 9.2% between
2023 and 2030, reaching a value of $287 billion (1).
As grow ing numbers of biotechs seek suppor t
from expert CDMOs, efforts must be made to f ur-
ther streamline timelines with a sharp focus on the
technology transfer process. Tech transfer is an in-
tegral part of drug development and manufacturing
during all stages through to the commercialization
of a product, making accelerating this process vitally
important. Success in tech transfer will ultimately
rely on seamless communication and staying current
on new regulatory expectations from across the globe
through every stage of a drug development project.
Tech transfer success also relies on a focused ap-
proach to process capabilities to ensure quality and
an understanding of any changes in the manufactur-
ing process as well as knowledge on how to apply the
process within regulatory compliance guidelines.
Built for speed
D r ug produc t (DP) m a nu f ac t u r i ng i s comple x ,
w it h ma ny procedures a nd processes t hat must
Tech Transfer and
Regulatory Compliance
Jinhyeok Jeong is senior
director of Drug Product
Inspection and Packaging,
and John Thomas is
senior director of Drug
Product MSAT; both at
Samsung Biologics.
Demand for efficient tech transfer,
as well as compliant on-time delivery, is rising.
MONTRI
–
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