Cell Banking Capabilities
Eurofins Lancaster Laboratories expands cell banking capabilities,meeting stringent Grade A and Grade B EU requirements
Enabling global clients to bring products to the market under both US and EU regulatory environments, Eurofins Lancaster Laboratories (ELLI) is enhancing its current cell banking capabilities. ELLI is doubling the number of cell banking cleanroom suites from two to four, adding longterm cell banking storage for both production and non-production cell banks, and increasing the maximum bank size from 400 to >1000 vials.
For many years, ELLI's Cell Banking Group has prepared a wide variety of mammalian cell banks in support of GMP production, GMP non-production (e.g., banks for bioassay), and R&D needs. Currently, the two suites used for the preparation of GMP production banks are designed to meet ISO5/ISO7 FDA clean-room requirements. The two new suites have been designed to meet the more stringent Grade A/Grade B EU requirements, therefore enabling global clients to prepare their production master and working cell banks in an environment that without question will be acceptable to EU Regulatory Authorities.
ELLI also provides extensive support to clients needing nonproduction master and working cell banks. These banks are typically used in cell based potency assays that are part of the lot release testing panel for a given product. In response to increasingly frequent requests for large banks of ready-to-use cells to support these assays, ELLI is currently validating the fill of banks exceeding 1000 vials at the cell concentration specified by the client. This service will be offered concurrently with the opening of our Grade A/Grade B suites.
Offering long-term storage solutions, cell banking clients may now elect to store part or all of their banks at the Lancaster, PA, facility.
The combination of these facility expansions and service offerings, high level of technical expertise in cell banking and characterisation, and extensive project management tools have been designed to provide clients with a single source solution for all cell line needs.
For more information, visit www.eurofins.com/biopharma.