APR Nov/Dec 2022 - 58

» FACILITY TOUR
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Global Support for ATMP Capabilities
Eurofins BPT has the largest network of harmonized bio/
pharmaceutical cGMP product testing labs around the world in order
to provide services to the global biopharmaceutical industry.
As the need for ATMP services in general and cell and gene therapies
specifically grows, Eurofins BPT is investing in facilities, technologies
and personnel worldwide to meet the burgeoning demand.
" In the the United States, the Lancaster, PA, laboratory is the lead site in
development of advanced capabilities and offers transfer of methods
to support clients working with Eurofins BPT sites in Columbia, MO,
and San Diego, CA, " says Marian McKee.
As the modalities employed for gene therapy change, Eurofins BPT
is able to adapt existing capabilities or add new ones to address the
emerging market. Currently, Eurofins BPT is able to support testing
and release of:
* Viral vectors for in vivo and ex vivo use
* Nanoparticles
* Plasmid based
* iRNA/mRNA
* Oncolytic Viral Therapies
* Allogeneic and Autologous Cell Therapies
In addition, Eurofins BPT has built global teams that are focused on
various product modalities, including traditional biologics and cell/
gene therapy.
" The global teams are tasked with sharing information about
regulatory trends, new testing approaches, and market demands from
both local and international geographies, " says Stanley Prince, Senior
Scientific Advisor Manager.
The company's laboratories in Europe and Asia Pacific are also making
significant investments to support the cell and gene therapy cGMP
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testing requirements. Some of the investments include ddPCR,
NexGen Sequencing, Viral Safety, and many more.
For product specific methods such as potency, infectious titer, and
others, Eurofins BPT has the ability to transfer methods for cGMP
testing between sites to accommodate product release in the various
geographies under various regulatory umbrellas.
The Future of ATMP and Cell and
Gene Therapy Testing Services
As the global market for these therapies continues to expand, Eurofins
BPT is committed to bringing the latest tools and technologies into
use for its current and future clients.
" We are continuing to gather information from our clients directly
as well as from conferences, " says Stanley Prince. " The information
we gather helps us to evaluate investments into new technologies
and methodologies to support the cGMP testing requirements of
these therapeutics. "
In addition, Eurofins BPT also participates in various regulatory
strategy review committees to review new guidance documents
and provide feedback to the agencies, discusses traditional biologics
testing problems that may negatively impact the cell and gene therapy
industry, and works collaboratively with companies globally to bring
new alternative approaches to help further progress the development
of these much-needed therapeutics.
References
1.
https://www.reportlinker.com/p06325351/Global-Cell-and-Gene-Therapy-Market.
html?utm_source=GNW
APR Nov/Dec 2022

Table of Contents for the Digital Edition of APR Nov/Dec 2022
