Viral Safety doubles laboratory footprint; builds new viral vector and ATMP lab to address growing demand

Marian L. McKee, Ph.D., Vice President, Biosafety & Stanley Prince, Senior Scientific Advisor

Eurofins BioPharma Product Testing is experiencing significant growth in GMP testing of both traditional biologics (mAb/protein therapeutics) as well as Cell & Gene Therapy (CGT) products, otherwise known as Advanced Therapeutic Medicinal Products (ATMP). To address the growing demand for viral testing across biologics and the challenges posed by the growing ATMP sector, Eurofins BPT is doubling the size of its Viral Safety Testing laboratories and adding a new lab focused specifically on viral vectors and ATMP product testing. This is all part of an overall strategy to support the ATMP product testing demands as well as expansion of the viral safety testing services that the biologics and ATMP clients require.

The Viral Safety and ATMP testing labs were designed with LEAN principals in mind to increase capacity and efficiency within the labs. Our scientists and LEAN team configured the workstations so that the biosafety cabinet, incubator, storage area for often-used consumables and notebook/ laptop space are within easy reach. This will reduce the time spent moving around, gathering supplies and most importantly transporting test samples within the lab. Analysts will also have direct access to the laboratory notebook that ensures contemporaneous documentation.

The new 7100 ft² laboratory space will accommodate the increase of unprocessed bulk harvest (UPB), lot release (LRT), and in vitro adventitious agent (IVAA) testing.

In addition to the optimized work station set up, lean flow principles and space utilization have been maximized in a number of ways, including: designated waste rooms isolated from lab, pass thru cabinets to transport materials between spaces, installed walk-in sample storage close to lab operations, designed shared anterooms between PCR lab and Main GCT lab, and installed rolling shelves to maximize consumable storage.

The ATMP lab was designed to accommodate many of the tests required to release viral vectors for use in cell and gene therapy applications. The space includes cell-based assay capability with various endpoints, including a PCR suite and immunoassay set up to accommodate endpoint analysis. The first methods to be launched out of the CGT/ATMP lab will be the replication competent and viral vector quantitation assays. The space is also designed to accommodate basic biochemistry set up for release testing, which may be added at a future date.

The new ATMP lab space and the expansion of the virology lab space will bring work to Eurofins that may require new ways of managing the logistics of testing execution. Anticipating these logistics changes, Eurofins has positioned specialized Project/Program Managers who will understand what the labs need in order to be successful in delivering seamless testing our clients expect. For more information, visit: www.eurofins.com/viral-vector-gene-therapies/