APR Sept/Oct 2023 - 86

»
FACILITY TOUR
»
FACILITY TOUR
Eurofins BioPharma Product Testing
Columbia, MO
Recent advances in genetic engineering have given clinicians a
more holistic understanding of normal and pathological metabolic
processes. Bio/Pharmaceutical companies have capitalized on this
knowledge to develop a wide variety of new biological and gene
therapy-based treatment options for infections and diseases.
The expansion of biologic modalities has led to an ever-growing
need for expertise in testing these unique drug candidates. Eurofins
BioPharma Product Testing (BPT) is a global leader in CMC Testing
Services, providing comprehensive testing for the biopharmaceutical
sector throughout the drug development life cycle.
Technical Capabilities at
Eurofins BPT Columbia
The Eurofins BPT facility in Columbia, MO, is an integral part of the
global Eurofins BPT network of laboratories. Constructed in 2007,
Eurofins BPT Columbia consists of a 100,000ft2
38,000ft3
facility, including
dedicated to stability suites with an emphasis on both small
and large molecule bio/pharmaceutical testing support. Additionally,
Eurofins BPT Columbia has a second location with approximately
6,800ft2
dedicated to the synthesis of 14C radiolabeled active
pharmaceutical ingredients to be used in phase 0/1 clinical trials.
Eurofins BPT Columbia has state-of-the-art biochemistry and bioassay
laboratories and additional laboratory spaces dedicated to cell culture
86 |
| September/October 2023
and storage, viral testing, PCR, high throughput multiplex electrochemiluminescence,
flow cytometry and analytical ultracentrifugation.
All of the aforementioned laboratories are BSL-2 compliant. The facility
has rigorous systems and processes in place to ensure sample and data
integrity, and all studies are conducted in compliance with ICH (Q2A
and Q2B), EU, JP, FDA and USP guidelines. The biologics laboratory has
supported testing of raw materials, drug substances, intermediates
and drug products from early phases of development through post
marketing commercial programs.
The biologics program in Columbia began in 2009 and rapidly
grew to be the largest service offering on-site. The site employs
approximately 120 dedicated laboratory scientists who have worked
on over 100 unique drug products. They have successfully completed
testing of mAbs, bi-functional mAbs, antibody drug conjugates,
recombinant-fusion proteins, PEGylated proteins, biosimilars, and cell
and gene therapy products including recombinant viral vaccines and
nanoparticle-based therapeutic delivery systems.
Eurofins BPT Columbia provides comprehensive testing services in
cell and gene therapy (CGT), biochemistry and functional bioassays.
Along with phase appropriate method validations and long-term
stability testing, the team also offers a comprehensive array of
product characterization evaluations, including molecular weight
determination, protein sequencing, peptide mapping, disulfide linkage
and other post-translational modification analyses. Studies requiring
SEC with various detectors, including MALS, MFI, charge variants,
product degradants, truncations and amino acid substitutions are
APR Sept/Oct 2023

Table of Contents for the Digital Edition of APR Sept/Oct 2023
