Cell Banking Capacity, Suites and Storage Expand
Jeri Ann Boose, PhD, Senior Director, BioPharmaceutical Sciences
This summer and fall, Eurofins Lancaster Laboratories (ELLI) will expand its current cell banking capabilities by doubling the number of cell banking clean-room suites from two to four, by adding long-term cell banking storage for both production and non-production cell banks, by increasing the maximum bank size from 400 to >1000 vials, and by offering insect cell bank production and testing services.
For many years, the Cell Banking Group at Eurofins Lancaster Laboratories has prepared a wide variety of mammalian cell banks in support of GMP production, GMP non-production (e.g., banks for bioassay) and in support of 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. Specifically, in these suites, the cell banks are prepared in an ISO5 biosafety cabinet within an ISO7 environment. The two new suites that will open this summer will meet the more stringent EU requirements of having a Grade a critical area within a Grade B environment. The new suites will therefore enable our global clients to prepare their production master and working cell banks in an environment that without question will be acceptable to EU Regulatory Authorities. All GMP-production cell banks are manufactured as campaign banks unless otherwise requested by the client. In addition, the equipment needed to support the preparation of insect cell banks will be available in our new suites, and concurrently, the assays to support insect cell bank characterization will also become available later this year.
ELLI also provides extensive support to clients who are in need of non-production master and working cell banks. These nonproduction 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 the increasingly frequent requests for large banks of ready-to-use cells to support these assays, ELLI is currently validating the fill of banks exceeding 1,000 vials at the cell concentration specified by the client. This service will be offered concurrently with the opening of our new clean-room suites this summer.
Finally, ELLI will now offer long-term storage solutions to our cell banking clients. Clients may now elect to store part or all of their banks at our facility in Lancaster, PA. This service will be offered in the fall of 2014.
The combination of these expansions to our facilities and service offerings, along with our high level of technical expertise in cell banking and characterization, and our extensive project management tools have been designed to provide you with a single-source solution for all of your cell-line needs. Please contact your Project Manager or Business Development Representative for more information.