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Cell Banking

The initial creation and storage of a cell bank is a key step in producing consistent biopharmaceutical and diagnostic protein-based or antibody-based products. A well developed and qualified Cell Bank will  assure a uniform population of cells is maintained and their integrity is preserved for many years. Access to such cells provides a sufficient supply of material during the product life-cycle.

Our Team has many years’ experience of creating cell lines, stable cell lines and hybridoma for a diverse client base including biopharmaceutical and diagnostic companies. We understand the value of these cells to you and treat them with the care and security that our clients expect of a company with a ISO13485:2016 certified Quality Management System (QMS). Having spent time creating these important cells we treat them with the same criteria when creating cell banks.

Using a controlled system for raw material traceability, production tracking and manufacturing records supported by our QMS our Team ensures that we provide a uniform population of preserved cells to enable you to store, thaw and expand these cells to produce the desired material for the life of the product. Our Team has worked with:

  • Mammalian Cells
  • Insect Cells
  • Bacteria
  • Hybridoma

We can produce cell banks from seed stock produced at Kemp Proteins for clients, or seed stock shipped to us for processing. Throughout the process your dedicated project manager will make sure you are constantly informed during the manufacturing process, from pre-seed testing and production of a batch record through the manufacture, release, and characterization testing of the cell bank. We will provide cell banks:

  • With vial-to-vial uniformity
  • High viability upon thaw
  • With Controlled Batch Manufacturing Records
  • Cells guaranteed to be contaminant-free

Following production of the cell bank, controlling the  security and integrity of your cell bank is our priority. We ensure the security and performance of the storage of your cells using a multilayered approach. Together with appropriate documentation this approach ensures that your cell bank vials are maintained under ideal controlled conditions.

  • In vapor-phase liquid nitrogen in a controlled systems
  • Divided and stored in multiple locations
  • Separate quarantined (untested) and released materials
  • Vial locations are identified and controlled for confidentiality and retrieval

We will ensure that Cell bank retrieval, use and shipment occurs only after we have received a written request from an authorized client representative. We can assist our clients ship cell bank vials to a specified third party or directly to the client to any destination worldwide. We are experienced in working with a number of Courier Services and are familiar with Import/Export requirements.

  • Vials of a cell bank are identified, removed from storage and transferred to an appropriate shipping container with a recording device that documents the temperature for the duration of the shipment
  • Documents
  • All vapor-phase liquid nitrogen shipments are shipped in accordance with client instructions

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