22 BioPharm International eBook April 2019 www.biopharminternational.com
Outsourcing Resources Bioanalytical Methods
Emerging Therapies Test Existing
Bioanalytical Methods
Cell- and gene-therapy drug development programs
demand novel and conventional bioanalytical methods
that require specialized expertise for complex therapeutic classes.
W
it h ma ny gene- a nd cell-t herapy
drugs in development, there is an
increased need for scientific expertise
to develop new bioanalytical technol-
ogies as well as use existing platforms
such as quantitative polymerase chain reaction (qPCR)
and flow cytometry within the regulated bioanalytical
space. Current FDA guidance provides little direction
on how to approach assay development and valida-
tion when using these emerging technologies, nor is
there guidance for the application of more familiar
technologies to gene-therapy applications. It is impor-
tant to understand the complex assays needed for
these programs and work with partners that provide
expertise to ultimately expedite these highly complex
therapeutic classes.
Davizro
Photography/stock.adobe.com
CHRISTINA SATTERWHITE, PHD, is senior director, global laboratory sciences;
JESSICA ST. CHARLES is director, laboratory sciences; VALERIE THEOBALD
is director, immunoanalytical services; and JENIFER VIJA is scientific director,
bioanalysis, all with Charles River Laboratories.
CHRISTINA SATTERWHITE, JESSICA ST. CHARLES, VALERIE THEOBALD, AND JENIFER VIJA
