SAFC has announced its plans to build a new high potency conjugation suite at its Missouri manufacturing plant in order to target pharma clients developing novel anti-cancer drug conjugates.
The US contract manufacturer said the new production suite will enable the conjugation of highly potent active pharmaceutical ingredients (HPAPIs) to a variety of targeted delivery molecules, such as monoclonal antibodies (mAb).
The new 600 sq. ft conjugation suite, expected to be operational at the end of the year, will produce early-stage clinical supplies of potent conjugated APIs, with the capabilities to expand production into commercial-scale.
Cancer drug development is undergoing a revolution shunning blanket bomb chemotherapeutics towards targeted anti-cancer missiles.
Combining traditional chemotherapy drugs to targeting molecules is one way of doing this and SAFC is hoping to tap into a potentially highly lucrative market for this new class of therapy.
Lonza, one of SAFC's main rivals, also recently announced its plans to moving to large scale production of the emerging drug class by 2008.
The Swiss contract manufacturer is currently upgrading its laboratory scale productions in Visp with the view to combining the company's two core sectors, antibody and chemical drugs manufacturing. Construction of a new commercial scale production unit in Visp started late last year.
The conjugation technology involves linking a mAb to potent cytotoxic drugs in order to target specific cells where the drug can be internalised and have its lethal effect, thereby sparing non-targeted cells. The drugs promise to be up to 100 times more efficient than chemotherapy.
Currently there is only one marketed therapy that utilises this technique, which is Wyeth's Mylotarg (gemtuzumab ozogamicin).
The drug is composed of a recombinant humanised immunoglobulin G4, kappa antibody conjugated with calicheamicin, a cytotoxic antitumour antibiotic. The antibody portion binds to the CD33 antigen which is found on the surface of leukaemic cells.
Mylotarg was approved in 2000 to treat acute myeloid leukaemia. Sales of the drug are currently around $20m (€14.7m) and could reach $60m by 2010, according to market research firm Decision Resources.
"High potency conjugation is an exciting new technology that demands a very special combination of specific skills. Adding HPAPI conjugation capacity enables SAFC to further vertically integrate our contract manufacturing services to pharma companies that are developing novel cures for cancer," said Franck Wicks, SAFC president.
"Adding specialised high-containment biologic capacity for performing potent conjugations was a logical extension to our business."
This latest investment comes hot on the heels of the company's recently announced plans to add HPAPI capabilities in the US and Israel, which represented a total investment of over $45m.