Contract Biomanufacturing

Alpha Biologics provides contract biomanufacturing services, mainly using batch or perfusion bioreactors, with roller bottle or wave reactor alternatives. Our R&D and process development labs develop and optimise processes for a range of cell types and micro-organisms.

Mammalian cell biomanufacturing processes take place in separate GLP or cGMP compliant suites, where they are optimised before transfer to our cGMP manufacturing facility. Typical R&D / process development services include:

  • Small-scale production for quality assessment
  • Expression plasmid expression / purification
  • Mammalian cell transfection and clonal selection
  • Cell line suspension and serum-free adaptation
  • Cell line cloning and high expression selection
  • Cell banking for "pre-master" cell bank candidate clones
  • Upstream (cell culture) process investigation, development & optimisation
  • Downstream (protein purification) process development
  • Assay development for specific proteins or products
  • Development and Technical Reports
  • Definition of process operating parameters and "edges of failure"

After the development and optimisation stages, contract biomanufacturing processes are transferred to Alpha's 5,000 sq metre cGMP manufacturing facility in Penang, innovatively designed to shorten the production phase, creating cost-effective solutions for our clients. Alpha's cGMP biomanufacturing facility primarily produces mammalian cell secreted proteins such as monoclonal antibodies and recombinant proteins - though products can also include mammalian cells, supernatants, membrane fractions or other options chosen by our clients. In addition to the above list of services, in our main cGMP manufacturing suites we offer:

  • Preparation of cGMP compliant batch documentation
  • Master and Working Cell Bank Preparation
  • Scale-up (Engineering) Runs
  • cGMP Upstream Manufacturing
  • cGMP Downstream Manufacturing
  • In-house product testing, QC analysis & testing
  • Bulk intermediate product fill
  • Quality Assurance and Regulatory Affairs
  • Cell line and product testing and characterisation studies using cGMP compliant partners
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