Services

CGMP Master Cell Banking

Master Cell Banking Services

Wheeler Bio’s team of experts utilize cutting-edge technology to provide CGMP master cell bank generation and testing with strict control standards and processes, ensuring a consistent cell bank that can be taken from clinical development to commercial manufacturing. We are dedicated to aiding our clients in efficiently achieving this critical CMC milestone in an accessible and transparent manner. In line with our commitment to transparency, our master cell banking services include access to real-time monitoring of vital equipment including cell analyzers and incubators. Further, as part of our Portable CMC® program, Wheeler can serve as your Working Cell Bank (WCB) provider as your program progresses to clinic.

 

Learn more about Wheeler Bio’s master cell banking services.

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Master and Working Cell Bank Generation

Portable CMC® Work Package 4


Wheeler Bio performs master cell banking as a stand-alone service, or as a module (Work Package 4) in our Portable CMC® offerings. The development of a master cell bank (MCB) ensures a traceable and consistent lineage for your cell line that will serve as the material basis for your drug development. Due to the critical nature of this milestone, Wheeler’s cell banking suite utilizes automation and single-use equipment to optimize efficiency and avoid any possible threats to cell bank purity. To complement these processes, our master cell bank development services also include real-time monitoring of incubators and freezer conditions through OSI PI Historian and temporary on-site storage of up to 300 MCB vials. Wheeler Bio also provides WCB generation and testing services with bank sizes of more than 300 vials.

For this crucial CMC milestone, Wheeler utilizes the highest-quality development and storage equipment within our manufacturing core including:

  • Nuaire Grade A Biosafety Cabinets
  • Eppendorf® New Brunswick™ S41i CO2 Incubator Shakers
  • -20°C and -80°C Thermo Fisher Ultra-Low Control Rate Freezers
  • Custom Biogenics Cryogenic freezer with 25,000 vial capacity
  • Sartorius Fill-It Cryovial Automated Filling System

Master Cell Bank QC Testing

You can trust Wheeler’s expert team to ensure that all master cell banks are held to the highest standards of purity and stability. Through our partnership with Charles River Laboratories and our utilization of the RightSourceSM QC testing lab located within Wheeler Bio’s manufacturing facility, we are able to capture all relevant data and ensure all MCB release and characterization testing adheres to the ICH Q5D quality standards and protocols, ensuring requirements will be met during the IND/BLA submission process.

Once these services are rendered, our clients can expect:

  • Up to 300 MCB vials
  • Approved master production records
  • MCB Certificate of Analysis (CoA) with BSE/TSE statement and cGMP compliance statement
  • Shipment of MCB to client-designated third-party storage facility

Interested in partnering with Wheeler for master cell banking or working cell banking?