Mammalian Cell Culture

Alpha Biologics cGMP manufacturing facility is dedicated by design to mammalian cell culture and in particular to the production of secreted proteins such as monoclonal antibodies or recombinant proteins. Having a dedicated mammalian cell culture facility minimises the risk of cross-contamination of products or cell lines by other organisms. It also simplifies operations, enabling Alpha to provide highly cost-competitive services.

The cGMP mammalian cell culture facility has stirred tank vessels ranging from 10 to 500 litres, and operates as a multi-product facility in line with the FDA design review. This allows Alpha to make products at the most efficient scale and at the best possible price.

At clients request, increased production capacity is achieved by combining stirred tank processes with tried and tested perfusion technology able to create a 20-fold increase in productivity per vessel. This combination of bioreactor and perfusion allows clients to produce as much secreted protein as needed for pre-clinical or clinical trial work - or early market use for some products.

• Mammalian cell culture capability: We work with most mammalian cell types, including hybridoma / CHO / NSO cell lines, to manufacture products. The proteins are produced in compliance with cGMP guidelines to enable our clients to conduct their clinical trials in the appropriate geographical locations.
  
  
• Monoclonal Antibodies and Recombinant Proteins: We develop processes designed for optimum yields of MAbs or rProteins while ensuring maximum purity and safety profiles for clinical trial or other use.
  
  
• Other products: in addition to monoclonal antibodies or recombinant proteins - at clients request we will produce mammalian cells, supernatants, membrane fractions or other product options.
  
  
• Cell Banking: On request, Alpha Biologics will develop stable cell lines and Master and Manufacturing Working Cell Banks prior to cGMP manufacture. We also provide cell line storage to ensure that subsequent manufacture can occur with minimal delays.