The global biopharmaceutical market is expected to grow at a Compound Annual Growth Rate (CAGR) of 12.5% reaching a value of $856.1B by 2030. Fueling this growth is the prevalence of chronic diseases, a growing geriatric population, rising investments in the research and development of new drugs, supportive international regulations and increasing adoption of biopharmaceuticals among the global population.
The testing of new biopharmaceuticals as they move from clinical trials to manufacturing is a vital step in bringing these advanced treatments to patients around the world. Ensuring the safety, efficacy, and quality of these treatments is increasingly being done by contract testing laboratories that offer the technical experience, facilities, and instrumentation for these products.
Eurofins BioPharma Product Testing (BPT) offers complete CMC Testing Services for the biopharmaceutical industry, including all starting materials, process intermediates, drug substances, drug product, packaging, and manufacturing support through a broad range of technical expertise in biochemistry, molecular & cell biology, virology, chemistry, and microbiology.
In the United States, Eurofins BPT offers seven key sites, including Lancaster, PA; Portage, MI; Columbia, MO; Charlotte, NC; Cary, NC; Jacksonville, FL; and San Diego, CA. This range of sites offers clients personal service backed by a unique global breadth of harmonized capabilities that supports all functional areas of bio/pharmaceutical drug development. Globally, Eurofins BPT has a capacity of more than 2,200,000 square feet and 44 facilities. This large network of GMP laboratories and vast experience allows BPT to support projects of any size from conception to market.
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 10 with charged aerosol detectors and one MALs detector. Other equipment includes three GCs with headspace, viscometers, and KF. All chromatography systems use validated Empower software.
Another capability was added in early 2021 when the site introduced cell-based potency assay development. To maintain the highest level of expertise, the facility hired veterans in this field, in addition to opening two cell culture labs equipped with BSCs, incubators, cell counters, microscopes, qPCR, ELISA plate reader, and flow cytometry.
To integrate all these offerings and harmonize with global quality, the San Diego facility uses Eurofins BioPharma Product Testing’s developed LIMS system, eLIMS-BPT, that is used by all the Eurofins BPT sites. Data is shared with clients via LabAccess.comSM, which provides them with a secure portal with 24/7 access to their data and reports.
The San Diego site can routinely test the following dosage forms:
- mRNA/Oligonucleotide/Plasmid Formulations
- Peptide DS and DP
- Protein DS and DP
- Small Molecule DS and DP
- LNP, PEGylated, Cyclodextrin, and Lyophilized Formulations
Industry Issues and Solutions
Being at the forefront of biopharmaceutical testing has given Eurofins BPT and the staff at the San Diego facility a unique perspective on some of the big issues facing the industry.
For example, there is a push in the industry to limit human interaction when it comes to the manufacture of sterile drug products (see section 4 of Annex 1). As mentioned earlier, the San Diego facility has responded to this push by acquiring a gloveless isolator containing a robotic filler for preparing sterile clinical supplies. This filler uses single-use components that makes for rapid turnover of the fill suite in preparation for the next drug product to be filled. The compact design of the robot limits line-loss thereby saving high value drug products.
Another industry issue is Part 11 compliance and data security, which has been a focus of the FDA in recent years. Eurofins BPT has an active program to ensure the data collected on its systems meets the major requirements, such as audits trails for all collected and processed data, secure data storage, and single user login. Newer technologies, such as cell and gene therapies and mRNA therapies, have evolving requirements that are discussed in BioPhorum working groups in which Eurofins BPT participates.
Data access and data security are also areas of industry concern. The expectation for 24/7 available data/reports and security are met with Eurofins BPT’s LabAccess.com secure data portal. To counter any potential threat of compromised data from malware, Eurofins has built its own network of servers based on zones that will isolate the impact of any attack to that zone. In addition, Eurofins BPT employs the latest anti-viral software to fend off potential attacks.
Future Trends and Future Plans
Eurofins BioPharma Product Testing maintains and develops strategic partnerships across the biopharmaceutical industry, including big pharma/biotech as well as emerging biotech companies, which ideally positions them to see trends developing, especially in their clients’ pipelines. As seen by their investments in the San Diego facility, they are continuously implementing new technologies, upgrading facilities, and engaging with personnel to support all modalities, including cell and gene therapy and mRNA technologies, and the ever-evolving GMP testing needs of the industry.
Eurofins Advantar Laboratories, Inc.
5451 Oberlin Drive #100
San Diego, CA 92121 USA
Tel: 858 228 7788
Web: www.EurofinsUS.com/BPT
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