The Cambrex business unit, comprising the two sites—Cambrex Baltimore and Cambrex Hopkinton—provides dedicated process development, analytical and cGMP manufacturing services for the manufacturing of bulk active pharmaceutical ingredients. With our extensive experience in scale-up and commercial manufacturing of recombinant proteins, vaccines and plasmid DNA, we can help accelerate your timelines through a fully integrated approach from development through pilot and mid-scale manufacturing of clinical materials. Our services include fermentation and recovery of products from microbial systems and we have expertise in recovery, purification and analytical tools to design and optimize your product yields.
Biopharmaceutical Techniques Supported
- Microbial fermentation and purification of bulk proteins
- Facilities and systems support of BSL-2 organisms and Class 5 compounds
- Transgenic milk purification
Globally, Cambrex provides clinical and commercial process development and cGMP manufacturing services to companies developing protein-based drugs and vaccines.
Products and Services
- Strain development
- Fermentation and recovery development
- Purification development
- Analytical development
- Bulk drug substance formulation development (including accelerated stability studies)
- Process characterization services including evaluating/defining critical process parameters and performing range finding studies
- 100-L non-GMP process scale-up and demonstration facility
- Six independent production trains offering cGMP bulk drug substance manufacturing with fermentation scale up to 2800L
- Process and analytical validation services
Cambrex Baltimore was originally established in 1990 as Bio Science Contract Production Corp., and one of the first bulk biopharmaceutical contract manufacturing companies in Maryland. Recently, Cambrex Baltimore underwent a successful FDA PAI inspection which contributed to a BLA approval for Tercica's Increlex.
Cambrex Hopkinton was founded in 1987 as Seragen Inc. and was one of the first companies to produce a licensed biologic and the Hopkinton team continues to manufacture it today.
Cambrex Hopkinton was first successfully inspected by the FDA (US Food and Drug Administration) in April 1998 (PAI inspection) and has since undergone several successful re-inspections. The facility was also successfully inspected by the EMEA (European Agency for the Evaluation of Medicinal Products) in August 2002 and December 2005 in support of commercial filings (MAA) on behalf of two major clients.
5901 East Lombard Street
Baltimore, MD 21224