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.
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.
Fig.1 Preparation of master and working cell banks. (Stacey, 2004)
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:
Creative Biolabs provides extensive capacity to manufacture MCB & WCB that meet worldwide cGMP regulatory standards and guidelines.
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.
For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.