Cambrex to biomanufacture for Merrimack
of clinical trial quantities of Merrimack Pharmaceuticals'
recombinant immunomodulatory serum protein, as its experience in
the downstream purification of proteins pays off.
The material Cambrex makes will be used in Merrimack's ongoing research to assess the potential of the drug, called MM-093, a human alpha-fetoprotein (hAFP) normally produced at very high levels by the fetus and present in low levels in the blood of adults and children.
Because the presence of hAFP in the pregnant mother's blood has long been associated with remission of many autoimmune diseases, Merrimack is conducting research to better understand the role of AFP in modulating the immune system and to assess MM-093's potential to improve the treatment of autoimmune disease.
The privately held company picked Cambrex as a leading contract manufacturer in North America with extensive experience in the downstream purification of proteins expressed in goat milk.
"Our experience with the purification of proteins from transgenic milk was certainly an advantage in successfully manufacturing Merrimack's MM-093," said Anthony Rotunno, vice president and general manager of Cambrex Bio Science Hopkinton.
"We were honored that Merrimack placed the current good manufacturing practice (cGMP) manufacture of their lead product in our hands as they progress MM-093 into future clinical trials."
Merrimack is currently conducting Phase 2 trials of MM-093 in patients with rheumatoid arthritis or with psoriasis.
Cambrex has completed several batches of MM-093 and is in the process of completing the production run, yet financial details of the agreement have not been disclosed.
The site the drug will be made in, in Hopkinton, Massachusetts, has capabilities from 40 litres to 2800 litres for microbial fermentation and purification.
The facility provides process development, analytical and cGMP manufacturing services for the production of active pharmaceutical ingredients (APIs) for clinical trials and commercial products.
Now a subsidiary of Cambrex, it was founded in 1987 as Seragen and was one of the first companies to produce a licensed biologic.