An Interview With...


Dr. Jeri Ann Boose Senior Director, Biopharmaceutical Services


Eurofins Lancaster Laboratories »


Can you explain how Eurofins Lancaster Laboratories is expanding its Cell Banking Capacity?


This fall, Eurofins Lancaster Laboratories is expanding 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.


Beyond increasing capacity, will any new cell banking capabilities be offered?


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 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.


Can you elaborate on your approach for generating production versus non-production cell banks?


All GMP-production master and working cell banks are manufactured as campaign banks in our clean room suite environments described above. Seed cells for these banks must be demonstrated to be free of mycoplasma, bacteria, yeast, fungi and molds prior to being taken into the suites. Strict cleaning and environmental monitoring procedures are adhered to during the manufacture of production cell banks. After the production cell bank has been generated, it is extensively tested to demonstrate purity, including freedom from viral contaminants as well as from mycoplasma, bacteria, yeast, fungi and molds. Identity testing is also performed, and genetic stability testing is usually requested as well.


14 American Pharmaceutical Review | Biopharmaceutical Supplement 2014


We also provide extensive support to clients who are in need of non- production master and working cell banks. These non-production banks are typically used in cell based potency assays that are part of the lot release testing panel for a given product. In contrast to production banks, non-production banks are typically prepared in clean laboratories in non-campaign fashion. The cleaning and environmental monitoring performed in these laboratories is not as strict as that performed in the clean room suites; however, the seed cells used to generate the banks must also test negative for sterility and mycoplasma prior to being expanded in the clean room laboratory. Post-bank testing of non-production cell banks is limited compared to that of production banks and usually involves only sterility and mycoplasma testing. The cells are also frequently tested for competency if the intent is to use them in a cell-based bioassay. Additional testing may be performed at the request of the client. In response to the increasingly frequent requests for large banks of ready-to-use cells to support cell based potency assays, Eurofins Lancaster Laboratories has validated the fill of banks exceeding 1,000 vials at the cell concentration specified by the client.


How will your cell bank storage capacity change?


We are offering long-term storage solutions to our cell banking clients, enabling them to elect to store part or all of their banks at our facility in Lancaster, PA.


How will your clients, and the industry, benefit from this expansion of cell banking capabilities?


In additional to the physical expansion of our cell banking facility and additional state-of-the-art instruments, our cell banking staff has also grown and includes managers and senior scientists with over 70 years of collective cell banking and testing experience, as well as junior scientists with over 25 years of collective experience. Our project managers are also specifically trained to handle cell banking projects, which offers a great advantage to our clients.


This combination of our service offerings and extensive technical expertise in cell banking, characterization and project management provide a platform for which we can serve as a single-source solution for all cell-line needs.


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