Cangene has considerable experience providing its customers with biopharmaceutical process development for plasma-derived proteins and recombinant proteins (bacterial and mammalian). For plasma-derived proteins, Cangene can apply leading edge process technologies related to purification and viral inactivation which have been employed successfully in several commercial products. For recombinant proteins, Cangene can provide fermentation and purification process development services designed to generate bulk product with the level of purity required for clinical and commercial use.

Cangene also has experience providing its customers with finished product development services for parenteral products, which includes formulation development and lyophilization cycle development and optimization. Cangene has applied its expertise to the development of a variety of products including plasma-derived and recombinant proteins and antisense oligonucleotides.

Cangene has a proprietary expression system, CANGENUS®, which can be used for recombinant proteins which are difficult to express in other systems. It is a microbial expression system which secretes bioactive proteins in soluble form with expression levels up to the gram per litre range. Cangene can do expression feasibility studies with the customer’s product and if successful, this can be followed by process development and scale-up to the manufacturing scale required for clinical studies.