Cangene - cGMP manufacturing service, Microbial Fermentation, Aseptic Fill / Finish and Aseptic Equipment

Cangene is a fully integrated biopharmaceutical company that provides a wide range of development and cGMP manufacturing services. The services offered fall into three main categories:

• Process development and scale-up
• Bulk product (API) manufacturing
• Finished product manufacturing

Cangene offers full service biopharmaceutical contract manufacturing capabilities including microbial fermentation, plasma fractionation, protein purification, aseptic filling, labeling, packaging and QC testing.

CGMP MANUFACTURING

Cangene has three facilities to provide cGMP-manufacturing services. These facilities include:

• FDA-licensed fractionation / filling facility for parenteral drugs
• Biopharmaceutical fermentation facility capable of manufacturing microbial-derived products up to the kilogram scale
• Aseptic filling facility which specializes in manufacturing sterile biopharmaceuticals

MICROBIAL FERMENTATION MANUFACTURING

The 61,000ft² biopharmaceutical facility is designed for the manufacture of microbial-derived recombinant proteins such as E.coli and other products at the 200L to 2100L working volume scale. Bulk API is provided to support all stages of clinical development up to commercial launch. There are three main manufacturing suites for each: fermentation, downstream processing and solvent handling / prep scale HPLC operations.

This multi-product manufacturing facility is designed to maximize the flexibility of processing operations. Processing capabilities include:

• Fermentation
• Cell breakage
• Chromatography
• Centrifugation
• Ultrafiltration
• Prep scale HPLC

Key equipment includes fully automated Braun fermenters (20L, 280L and 2800L), Alfa Laval BTPX205 centrifuge, Carr P12 centrifuge, Rannie homogenizer, UF / DF skid, Bioprocess chromatography skid and Biotage HPLC skid.

ASEPTIC FILL / FINISH MANUFACTURING

Cangene’s FDA-licensed fractionation / filling facility is a 125,000ft², multi-product facility. It is designed for the manufacture of bulk API for plasma-derived hyperimmunes and other parenteral products up to the 1,000L scale. A new 43,000ft² manufacturing suite is under construction to significantly increase capacity.

The filling suite is designed for aseptic filling manufacturing of parenteral products with vial sizes in the 2ml – 50ml range for batch sizes of 1,000 to 50,000 units. Lyophilization in a fully automated freeze dryer (33ft²) is also available to provide batch sizes up to 7,500 units. Fully automated labelling / packaging / inspection services are also available along with a full range of support services.

ASEPTIC EQUIPMENT

Key equipment includes a high speed Bosch TL filling machine, West capping machine, NJM/CLI labeller and Serail freeze dryer.

Aseptic fill / finish manufacturing experience includes recombinant proteins, plasma-derived proteins, plasmid DNA, liposomes and oligonucleotides. These products are manufactured in full compliance with cGMP in our FDA-licensed facility.

CBL STERILE MANUFACTURING FACILITY

Chesapeake Biological Labs (CBL), established in 1980 and now a subsidiary of Cangene, is a recognized leader in the development and production of sterile biopharmaceuticals. Through the formulation of strategic partnerships with clients, CBL serves as the single source of service, from technical transfer to scale-up and commercial production.

CBL has a 70,000ft² aseptic filling facility in Baltimore, Maryland, designed for sterile manufacturing of vials and syringes. Aseptic filling of small volume parenterals (SVPs) is accomplished in one of three class 100 cleanrooms.

This multi-product facility has vial-filling capabilities in the 3-100ml range with batch sizes from 500-100,000 units. Lyophilization of products is performed in a fully automated freeze dryer (240ft²) to provide batch sizes up to 50,000 units. Syringe filling capacity is also available for lots of up to 25,000 units.

Vials can be filled on two high-speed filling lines: Bosch eight head filler or Chase Logeman two head filler. Pre-sterilized syringes can be filled on two machines: Innova two head filler using mechanical plunger insertion or Cazzoli five head filler utilizing vacuum stoppering.

Aseptic fill / finish manufacturing experience includes a variety of sterile biopharmaceuticals. These products are manufactured in full compliance with cGMP in an FDA and EMEA inspected facility.