Cell Bank Creating and Preserving Services

There is an increasing appreciation of the role live biotherapeutics play in multiple human indications. Live biotherapeutics uses natural or engineered microorganisms that can be designed to sense and respond to environmental signals to consume harmful compounds and deliver therapeutic effectors. Based on our expertise in microbiota and microbiome science, Creative Biolabs provides comprehensive services for the development of live biotherapeutics products (LBPs), including but not limited to the formulation, cGMP manufacturing, and delivery development to produce stable high-quality LBPs from carefully selected strains.

Introduction of Cell Banking

For quality LBPs production with continued stability and safety, it is the first critical step to establish a cGMP master cell bank (MCB) and working cell bank (WCB). Cell banking assures that you have an adequate supply of equivalent, well-characterized, source-consistent cells for LBPs production. Besides, cell banking provides an opportunity to undertake a comprehensive characterization of a cell-substrate and minimize the likelihood of adventitious agent contamination.

Preparation of master and working cell banks. Fig.1 Preparation of master and working cell banks. (Stacey, 2004)

Microbial Cell Banking Applications

Similar to mammalian cell banks, microbial cell banks are created and stored under appropriate, controlled conditions. Our aseptic cell banking is created within certified laminar flow II biosafety level cabinets with Class A high-efficiency particulate air (HEPA). They can be used as substrates for:

  • Recombinant product generation
  • Plasmid generation
  • Bacteriophage generation

GMP Microbial Cell Bank Generation

Creative Biolabs provides extensive capacity to manufacture MCB & WCB that meet worldwide cGMP regulatory standards and guidelines.

  • We detailly describe the type of banking system, including the size of the cell bank(s), the container and closure system used, the methods used for the preparation of the cell bank(s), such as the cryoprotectants and media used, and the conditions employed for cryopreservation and storage.
  • We detailly describe the procedures used to avoid microbial contamination and cross-contamination by other cell types.
  • We detailly describe cell banking procedures.

GMP Microbial Cell Bank Capacity

  • Cell bank facility for GMP manufacture (strictly sterile workstation internal HEPA filtration)
  • Abundant experience in manufacturing E. coli, yeast, and other aerobic and anaerobic microbial cell banks
  • Up to 800 GMP cell banks can be generated
  • Automated filling system
  • Long-term GMP cell bank storage and testing availability

Microbial Cell Bank Validation and QC Testing

  • Culture identity (Gram stain, PCR analysis, and sequencing, etc.)
  • Bacteriophage detection (by induction with mitomycin C or exposure to UV radiation)
  • Purity testing to identify contaminating organisms
  • Viability testing to identify the number of viable organisms by enumeration (CFU assay/colony counting)
  • Genetic stability (retention of the selectable markers and recombinant construct, copy number determination, restriction map analysis)
  • Sequence integrity of the gene of interest (DNA/RNA sequencing)

Microbial Cell Bank Storage

  • Cells suspended in preservation medium are aliquoted from the single pool into sterilized containers
  • Sealed and stored under appropriate conditions
  • Long-term storage at -80 ℃ or in the vapor or liquid phase of liquid nitrogen
Cell Bank Creating and Preserving Services

With industry-leading expertise and state-of-the-art single-use equipment, Creative Biolabs has pioneered the scale-up manufacturing of customers’ LBPs, extending from aerobic/anaerobic organisms identification, analyses & qualification, to scalable and fully-closed axenic production processes. Our specialized team is responsible for the manufacture of MCB & WCB that meet worldwide cGMP regulatory standards and guidelines. We will work with you at all stages of the cell bank development process from the initiation of your project to the large-scale production of your cells and microbes.

If you are interested in our services, please feel free to contact us.

Reference

  1. Stacey, G. 15 Fundamental Issues for Cell-Line Banks in Biotechnology and Regulatory Affairs. 2004.

For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.

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For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.

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