30 BioPharm International eBook March 2018 www.biopharminternational.com
Outsourcing Resources Analyzing Biologics
Gaining Analytical Insight in the
Development of Biologics
Contract testing organizations can provide bio/pharma companies with
a cost-effective way to adapt to new technologies and regulations.
SUSAN HAIGNEY
I
mprovements in analytical technologies provide
increased capabilities to examine proteins, cell lines,
raw materials, and drug product throughout the drug
development and manufacturing process. Regulatory
expectations have also evolved. These new analytical
requirements can tax the resources and technical capa-
bilities of drug companies.
Contract testing laboratories, which traditionally pro-
vided specialized testing services and expertise, are
playing new roles in the current biopharmaceutical
development market. To gain insight on what spon-
sor companies can gain from outsourcing their ana-
lytical processes, BioPharm International spoke with Jure
Kapetan, managing director Eurofins BioPharma Product
Testing D/A/CH; Wei Pan, director strategy and ana-
lytical CMC, development and analytical services at
Catalent Pharma Solutions; and Michael Merges, direc-
tor of strategic growth, biologics analytical services, at
Catalent Pharma Solutions.
OUTSOURCING BRINGS
EXPERTISE AND CAPACITY
BioPharm: What are the benefits of outsourcing analyti-
cal processes?
Pan and Merges (Catalent): While the outsourcing of
small-molecule analytics is commonplace and the infra-
structure of development partner/sponsor collabora-
tions is extremely well developed, the same is not true
DEXTROZA/SHUTTERSTOCK.COM
