Pharmaceutical NEWS - Fall 2009

Cell Bank Manufacturing Suites and Storage capabilities added

Building on their knowledge of clean room technology, Lancaster Laboratories now offers manufacturing and characterization of a wide variety of mammalian cell banks, including master, working and research banks. To augment this new service, Lancaster Laboratories is tapping into the cold chain management expertise of sister company Fisher BioServices to provide cell bank storage in an on-site, world-class biorepository. Lancaster Laboratories’ extensive list of cell banking services provides a single source solution for cell line needs.

Principal Scientist Julie Wilbur performs aseptic
filling in Lancaster Laboratories’ cell bank manufacturing suite.

Lancaster Laboratories’ manufacturing facility is designed to meet current aseptic processing guidelines outlined in FDA’s Guidance for Industry: “Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice,” and features multiple ISO 7 clean rooms and ISO 5 critical areas. Manufacturing procedures are fully validated and include process simulation studies to ensure the integrity of the manufacturing process. Other available equipment includes class 100 biosafety cabinets, controlled rate freezers, CO2 incubators and automated cell counting (Vi-Cell®).

Characterization of cell banks is available in the following areas:

• Identity
• Microbial Contamination
• Contamination
• Stability
  

“We want to make this process seamless, so that when a client contracts with us for their cell banking needs, they get a comprehensive set of services,” explains Mark Kaiser, biopharmaceutical director. He adds that Lancaster Laboratories is well-suited for this work because they already perform the tests required for characterization of cell lines, operate in a cGMP compliant facility, and have personnel on staff with more than 15 years of cell bank manufacturing experience.

This world-class biorepository enables Lancaster Labs to
provide on-site cell bank storage through partnership with sister
company and cold-chain management expert Fisher BioServices.

By partnering with Fisher BioServices, Lancaster Laboratories is able to offer secure, compliant storage and shipping options for the cell banks they manufacture. Their state-of-the-art biorepositories provide efficient retrieval and shipment to clients, including same-day service. A variety of storage options, including vapor-phase liquid nitrogen and liquid-phase liquid nitrogen, are offered to meet client’s specific needs. Storage is available in segregated and non-segregated environments. Around-the-clock monitoring of storage areas, along with emergency backup systems and disaster recovery plans, ensure the integrity of samples.
Compliant and efficient transportation of cell banks, using calibrated monitoring probes, eliminates the potential for temperature deviations and related consequences. Cell banks are packed and shipped in full compliance with federal regulations and customer requirements.

For more information on cell banking services, call Pharmaceutical Business Development at 717-656-2300.