Development

The BDU team has a wealth of experience in developing cGMP compliant manufacturing protocols for biological products. Small scale chromatography equipment is in place to enable efficient transfer from lab to manufacturing suite. 

The BDU has the ability to create novel QC methods for product testing.

The department liaises with research groups to enable the efficient and timely scale up of the manufacturing process.

Process optimization ensures that the best possible yields are obtained. 

The department has improved product safety by moving away from the use of animal-based raw materials.

Methods Used:

• Upstream - fermentation, hollow fibre and spinners
  
  
• Downstream - dead end filtration, cross flow filtration, column chromatography and centrifugation
  
  
• Formulation - most products are formulated in to PBS but the department has experience with products whose formulation requirements have differed
  
  
• Assay Development - product specific assays set up (ELISA) along with assays to confirm purity and conformity (HPLC).

The Development department is capable of developing a GMP compliant manufacturing protocol that meets your requirements.