Cell and gene therapies (CGTs) are transforming modern medicine by offering the potential to treat, and in some cases, cure diseases that were previously considered untreatable. These include rare genetic disorders, cancers, and complex chronic conditions.
However, bringing these therapies to patients presents significant scientific and operational challenges. The development of CGT programmes relies on multiple, interdependent components: cell substrates (e.g., cell lines), vectors (viral and non-viral), and genetic payloads (therapeutic targets). Compared to traditional biologics, developers must address low abundance targets, heterogeneous starting materials, and evolving manufacturing processes.
Eurofins BPT’s Cell and Molecular Biology Method Development & Validation team in Lancaster, PA, helps clients navigate these challenges by designing analytical strategies that span early stage materials to final drug products:
- Cell Lines: allogenic (donor-derived), autologous (patient-derived), cell banks
- Drug Substance / Drug Product / In-Process: adeno-associated viral (AAV), adenoviral (AdV), lentiviral vector (LVV) therapies
- Raw Materials: peptides, enzymes, media components
- Biologics: monoclonal antibodies, recombinant proteins, vaccines, antibody drug conjugates (ADCs)
Our team offers a broad and versatile range of methods, ranging from platform validated approaches to fully customised method development. Seamless transfer to routine quality control environments is supported by our team’s sister department, Molecular and Cell Biology Routine Testing. These method capabilities are essential for robust
characterisation, contamination control, and reliable quantitation, which are important for product safety and regulatory confidence.
- Adventitious Agent Detection: human virus panel, porcine circoviruses, retroviral contaminants by fPERT, mouse minute virus, detection of mycobacteria
- Residual Contaminant Testing: host cell DNA, E1A, SV40 large T antigen (LTA), antibiotic resistance genes (i.e., kanamycin, ampicillin)
- Characterisation & Identity: species identification (COI PCR or barcoding), Sanger sequencing analysis
- Quantitation: residual vector/plasmid, genomic titer by ddPCR
- Immunochemical & Cell-Based Assays: host cell protein (HCP) via ELISA, cell death/proliferation, infectious titer (TCID50), potency
We possess a strong foundation in cGMP requirements and alignment with global regulatory expectations, including FDA and EMA guidelines - all of which help advance CGT programmes efficiently, supporting the delivery of transformative therapies to patients.
For more information contact us at: BioPharmaProductTesting@BPT.EurofinsUS.com or visit: Eurofins BioPharma Product Testing.