Living cells are at the heart of biotechnology, and cell lines for production and testing of biopharmaceuticals are highly valuable assets. The process of banking cells generally moves from development of a research cell bank (RCB) based on a clone of interest to establishment of a master cell bank (MCB), from which working cell banks (WCBs) can be produced. Especially for biotechnology startups, preparation and characterization of an MCB can involve a significant jump from work performed in standard laboratory conditions to good manufacturing practice (GMP)-compliant operations. For such reasons, biopharmaceutical developers usually delegate MCB preparation to contract development and manufacturing organizations (CDMOs). This featured report explores some of the processes that go into ushering cell banks from their earliest forms to those that enable GMP production of biologics. Read the articles below to learn about cell banking best practices gathered from biopharmaceutical developers, contract manufacturers, academic researchers, and industry consultants.
Cell Banking in the Spotlight: Advising Biologics Developers
About Cell Bank Preparation and Characterization
Brian Gazaille, with Francisco Castillo and Raymond W. Nims
This past spring, BPI’s associate editor corresponded with two biopharmaceutical industry consultants to determine cell banking best practices for biologics companies that are passing their research-grade materials to contract manufacturing partners. The contributors call attention to aspects of cell-bank preparation and characterization with which biologics developers sometimes struggle, especially regarding assurance of monoclonality and documentation of animal-derived raw materials. Then the discussion turns to resources from which developers might benefit as they seek out contract partners for MCB preparation and characterization.
Contractor Perspectives: Best Practices for
Transfer, Handling, Testing, and Storage of Cell Banks
S. Anne Montgomery, with Scott M. Wheelwright and H. Fai Poon
BPI’s editor in chief speaks with executives from Chinese CMOs BioInno Bioscience and QuaCell Biotechnology to learn how such organizations develop quality assurance (QAs) practices for cell lines received from drug sponsors. The contributors not only give detailed criteria for cell bank storage and handling, but also offer a glimpse into the ongoing harmonization of global regulatory practices and the alignment of best practices for maintaining MCB/WCB quality and integrity.
Cell Banking for Cell and Gene Therapy: Regulatory, Scientific, and Ethical Considerations
Laertis Ikonomou, Aaron D. Levine, Peiman Hematti, and Bruce L. Levine
Members of the International Society for Cell and Gene Therapy (ISCT) Presidential Task Force on the Use of Unproven and/or Unethical Cell and Gene Therapies call attention to the persistence of speculative private human-cell banking services. In contrast with cord-blood banking and (usually public, but sometimes private) cell banking agencies that provide material for research purposes, such speculative companies focus on long-term cell storage with an unclear path to clinical translation. The authors herein describe ways to discourage development of dubious cell banking services, emphasize the need for cell banking organizations to work closely with regulatory authorities, and explain why public cord-blood banks offer a useful template for banking other cell types for other purposes.