APR Nov/Dec 2022 - 57

« FACILITY TOUR
compliant CMC testing support to ensure the identity, potency, purity,
and safety of starting materials, intermediate products, vectors, and
final drug products as well as support for manufacturing process
development and validation.
Responding to a Growing Market
Eurofins BPT is experiencing significant growth in cGMP testing of
both traditional biologics (mAb/protein therapeutics) as well as Cell
& Gene Therapy (CGT) products or ATMPs. To address the growing
demand for testing across biologics and the challenges posed by
the growing ATMP sector, Eurofins BPT is increasing the size of many
of its laboratories and adding a new lab focused specifically on viral
vectors and ATMP product testing. This is all part of an overall strategy
to support the ATMP product testing demands as well as expansion of
the viral safety, biochemistry, and molecular testing services that the
company's ATMP clients require.
Commenting on this growth, Marian McKee, PhD, Vice President of
Biosafety said, " The ATMP lab was designed to accommodate many
of the tests required to release viral vectors for use in cell and gene
therapy applications. The space includes cell-based assay capabilities
with various endpoints, including a PCR suite and immunoassay set up
to accommodate endpoint analysis. The first methods to be launched
out of the CGT/ATMP lab will be the replication competent and viral
vector quantitation assays. The space is also designed to accommodate
basic biochemistry set up for release testing and affords space for
future expansion as demand grows. "
A Closer Look at ATMPs and Cell and
Gene Therapy Services
" Eurofins BPT has a long history of offering cGMP-compliant CMC
testing of starting materials, intermediate products, vectors, and final
drug products and supporting manufacturing process development
and validation, " says Marian McKee. " This includes testing of raw
materials, cell and viral bank services, plasmid and viral vector
testing, lot release testing, bulk and finished product testing, and
stability studies. "
For cell and gene therapy products, Eurofins BPT provides cGMP testing
services to support both autologous and allogeneic cell therapies,
including rapid sterility (BAcT/Alert 3D technology) and mycoplasma
(MycoSEQ Real Time Detection System for Mycoplasma). Within the
Eurofins BPT network of companies, analytical ultracentrifugation to
support regulatory expectations around empty/full capsid analysis has
been added recently. Eurofins BPT has also invested in technology to
allow rapid sterility testing requirements for autologous cell therapies
and digital droplet PCR for more precise quantitation of viral particles.
Investments in Eurofins BPT facilities expand CGT capabilities and
include laboratories being updated to accommodate biosafety level 2
(BSL2) work to maximize space utilization and to optimize workflows.
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Investments in Cell and Gene Therapy
Testing Technologies
With the industry's drive to bring more cell and gene therapy products
to patients, comes the inevitable need to implement the latest
technologies and instruments to test and analyze these ATMPs. Eurofins
BPT is making significant investments in facilities and instruments to
ensure the company has the most up-to-date capabilities.
" As clients' needs and market trends evolve, we've been in lockstep
by expanding our lab space and capabilities specifically with our new
transmission electron microscopy (TEM) lab in a newly built laboratory
space designed to support the company's ATMP testing offering, " said
Marian McKee.
The addition of electron microscopy allows Eurofins BPT to offer a full
panel of in vitro test methods required for bulk harvest (UPB) testing
and cell line characterization (CLC). The TEM lab will complement the
cell and gene therapy testing services for viral vector characterization,
including analysis of capsid architecture and empty/full analysis.
Marian McKee continues, " In addition to the new lab space for
TEM, Eurofins BPT is investing in expansion of molecular biology,
biochemistry, sterility, mycoplasma, viral safety, and raw materials
testing, as well as stability laboratories across its Lancaster campus.
Much of these enhancements are in response to the growing demand
from the advanced therapy market. "
The addition of new instrumentation and technology is designed to
handle the smaller sample volumes inherent to cell and gene therapy
and for specialized testing. Examples include ddPCR, Maurice, Ella,
Flow Cytometers and Analytical Ultracentrifugation (AUC).
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APR Nov/Dec 2022

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