EBPT Cell Banking certified by global regulatory agencies

Marian L. McKee, PhD, Vice President, BioPharma Biosafety Testing, EBPT Lancaster

In biomanufacturing, cell banks play a key role in the production of biologic drugs. Cells banks, such as CHO or HEK-293 cell lines, are critical raw materials in the manufacture of antibody-based or viral-based therapeutics. Assuring that cell banks are manufactured under strict quality requirements in accordance with current regulatory expectations is paramount to ensuring the ultimate safety and purity of these biopharmaceuticals. The process begins with the integrity of cell banks being used in the manufacturing of the biologic drugs.

By definition, a biologic is a pharmaceutical drug product manufactured in, extracted from, or semi-synthesized from biological sources. These can include vaccines, monoclonal antibodies, recombinant proteins, blood-derived products as well as gene therapy vectors and cell therapies. These drugs may be produced using human, animal, or microorganism derived cells.

To ensure the consistency of the resulting drug product, it is important that the cells are produced in adherence to a strict quality system. To meet the expectations of the industry, Eurofins BioPharma Product Testing (EBPT) in Lancaster, PA, is regularly inspected by domestic and international regulatory agencies such as the Food and Drug Administration (FDA) in the United States, Therapeutic Goods Administration (TGA) in Australia, European Medicines Agency (EMA), and Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.

At inspection, these agencies review the practices and policies that guide the production of cell banks for manufacturing as well as the facilities and equipment in use where the cells are handled. All work is expected to be performed in accordance with current Good Manufacturing Practices (cGMP) as outlined in governing laws and guidance documents in each jurisdiction (for example but not limited to, 21CFR Part 211 in the US and EudraLex Annex 1 in Europe) as well as internationally recognized guidance, such as the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use ICH).

The Cell Banking Department at Eurofins BioPharma Product Testing in Lancaster, PA, has been inspected and received certification from the FDA (2017), TGA (2022), EMA (2023), and PMDA (2023) for cell bank manufacturing.

To gain these accreditations, the practices in cell banking have demonstrated adherence to these stringent regulatory requirements and client expectations when expanding cells to create Master and Working Cell Banks (MCB and WCB, respectively).

All operations in the Cell Banking group are performed under the Eurofins BioPharma Product Testing Quality Management System (QMS), which includes Quality Assurance oversight and clearance of key steps in production. Cell banks for manufacturing are expanded, vialed, and preserved in dedicated suites with defined workflows, which meet regulatory expectations with regard to environmental conditions (air flow, HEPA filtration, and environmental monitoring).

Grade A/B classified suites with anterooms and pass throughs are used for all production bank work.

To accommodate different manufacturing approaches, suites are further segregated into Animal Origin Free (AOF) and non-AOF suites.

Controlled processes in the Cell Banking group include: Employee training, gowning, and aseptic technique qualification; a documented contamination control strategy; control of material, personnel, and waste flow in certified suites; equipment qualification and maintenance; documentation using the ALCOA+ principle; review of documentation for accuracy prior to release; and release testing with a Certificate of Analysis for each bank manufactured.

Whether cell banks are needed for manufacturing and filing in the US, or the plan is for a cross geography product launch, the EBPT Cell Banking laboratories are ready and meet quality standards around the globe.