APR May/June 2023 - 39

« FACILITY TOUR
A Closer Look at the San Diego
Facility
The San Diego facility is a full-service drug development laboratory,
which provides clients with GMP testing services for all phases of
drug development in addition to commercial testing support. The
facility has a broad range of capabilities for both biologics and small
molecules that includes the following:
* GMP Sterile Fill-Finish Manufacturing (up to 3000 vials)
* Method Development and Validation for both Drug Substance
(DS) and Drug Product (DP)
* Formulation Development
* Cell Based Potency Assay Development
* DS and DP Characterization by LCMS and Other Techniques
* GMP Release Testing and Stability Studies (Phase 1
to Commercial)
* GMP Non-sterile Manufacturing (atypical APIs, topicals and oral
liquids, excluding oral solids)
*
*
Clinical Packaging and Distribution
In-Use Studies
* Shipping Simulation Studies
Established in 2008 as Advantar Laboratories the site initially focused on
early phase peptide, oligonucleotide, and small molecule development
for its clients. Eurofins BPT acquired Advantar Laboratories in 2016,
made significant investments in high-end instrumentation, and
provided the support needed to allow the facility to advance further
into biologics and late phase testing.
Facility Adaptations and Strengthened
Technical Expertise
Over the years, the San Diego facility has expanded its range of services
and technical expertise, growing from its initial early phase offerings to
now include late phase development and validations. The site is proud
of the fact that it has ushered early phase clients all the way through
the development cycle to commercialization and can continue to test
their products once they are fully marketed products. Since being
formed, the facility has also added expertise in late phase biologics
testing and offers CE-SDS, cIEF, variable path-length UV, peptide
mapping, MFI, ELISA, and cell-based potency assays. Additionally, the
facility has expanded their oligonucleotide offering into the mRNA
and LNP space. Before, during and after the pandemic the San Diego
facility was also testing mRNA encapsulated early phase products.
Rounding out its service offerings to early-phase clients, the site
has added GMP sterile fill finish capabilities and in 2019 acquired a
gloveless, robotic isolator (Vanrx Microcell) for filling client's sterile
clinical supplies. The site has successfully filled several clients' GMP
clinical supplies to enable their clinical trials.
Staff Expertise and
Equipment Capabilities
As the need for newer and more advanced services have become
essential, the staff at the San Diego facility continues to evolve
to meet new challenges.
The site currently has 106 employees of
which over 15% hold a Ph. D. in chemistry, biochemistry, or a related
field. The senior staff of directors all have more than 20 years of
biopharmaceutical industry experience.
Looking at equipment and instrument capabilities, the site offers a
vast array of equipment, including four LCMS (two QTOFs and two
triple quads). In addition, the site boasts 55 HPLC/UPLCs, including
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APR May/June 2023

Table of Contents for the Digital Edition of APR May/June 2023
