Cell Bank Manufacturing

Test Articles

We offer services in support of these test articles.

 
 

Cell Bank Manufacturing

Lancaster Laboratories offers capabilities to manufacture, store and characterize a wide variety of mammalian cell banks, including master, working and research banks and expertise in cold-chain management. Our cGMP-compliant manufacturing facility includes multiple ISO 7 clean rooms and ISO 5 critical areas designed to meet current aseptic processing guidelines. Fully validated manufacturing procedures include process simulation studies to insure the integrity of the manufacturing process.

Why Lancaster Laboratories?

Our manufacturing, storage and cold-chain management capabilities coupled with comprehensive characterization services provide you with a single-source solution for all of your cell line needs.

Leadership of Group:

 

Mark Kaiser – Director 26 years with Lancaster Laboratories

Weihong Wang, Ph.D. – Manager9 years of related industry experience

 

 
 

Services available:

  • Cell Bank Manufacturing
    • Preparation of mammalian cGMP Master and Working Cell banks
    • Preparation of research banks

  • Master Cell Bank Characterization
    View chart of Recommended Testing for Master Cell Banks (MCB)

    • Identification
      • Isoenzymes
      • Karyology
    • Microbial
      • Sterility
      • Mycoplasma
    • Adventitious Viruses
      • In vitro viral testing
      • In vivo viral testing
    • Specific Viruses
      • Bovine Viruses
      • Porcine Viruses
      • Rodent Viruses (MAP, HAP, RAP)
    • Retroviruses
      • S+ L-, XC, MCF
      • TEM
    • Stability
      • Copy number
      • Restriction enzyme digestion map
  • Working Cell Bank Characterization
    View chart of Recommended Testing for Working Cell Banks (WCB)

    • Identification
      • Isoenzymes
    • Microbial
      • Sterility
      • Mycoplasma
    • Adventitious Viruses
      • In vitro viral testing
      • In vivo viral testing
  • Cell Bank Storage
    • Storage Capacity & Access
      We provide on-site and global storage in state-of-the-art, world-class biorepositories with rapid retrieval of samples and secure shipment to customers, including same-day service.
    • Storage Options
      We offer a variety of storage options to meet your specific needs and maintain long-term sample integrity including, vapor-phase liquid nitrogen and liquid-phase liquid nitrogen. Storage is available in segregated and non-segregated environments.
    • Security
      We provide 24/7/365 equipment monitoring with on-call manpower for after- hours alarms and full-disaster recovery plans. All sites have emergency-system backups, so your samples are safe and secure even in the event of a power failure. Contingency/backup freezers ensure that your sample safety is maintained in the event of equipment failure, and we maintain redundant and backup storage capabilities in the event of a catastrophic failure at a customer site. We provide monthly product integrity reports with temperature tags.
  • Cold Chain Management
    • Compliant & Efficient shipping solutions
      Worry-free transportation of cell banks eliminates potential for legal and regulatory temperature deviations or related consequences. All monitoring probes are calibrated to NIST/UKAS traceable standards. Cell banks are packed and shipped by certified employees in full compliance with IATA or DOT regulations and customer requirements.

    Contact

    Request additional information to start working with us today. Or call one of our Business Development Specialists at 717-656-2300.

Facilties and Equipment:

  • Multiple ISO 7 Clean manufacturing suites designed and qualified to meet aseptic processing guidelines.
  • Class ISO 5 Biosafety cabinets
  • Qualified controlled rate freezers
  • Qualified CO2 Incubators
  • Automated Cell Counting (Vi-Cell™)