SAN FRANCISCO -- It may not be music to the ears of small and medium-sized contract manufacturing organizations, but Samsung Biologics said Tuesday it plans to expand its current business to cover smaller volumes.
“We decided to add sCMO to our service for client satisfaction, to keep providing support to our contract development clients who need small batches of drug substance for their subsequent clinical phase one trials,” said Regina Choi-Rivera, head of the sCMO business unit at Samsung Biologics.
SCMO, short for small-scale CMO, is the newest business unit of the company, opening in October 2019.
Choi-Rivera has been with the company for a little over six years, and has led the project management team for technology transfers. Before Samsung Biologics, she had a decade of experience at Janssen Pharmaceutical and other global pharma businesses.
Choi-Rivera is now set on nurturing the sCMO division, which she calls the engine of Samsung Biologics, saying she cannot bear to hear it called a mere catalyst.
“Once our CDO (contract development organization) clients finish preclinical trials on animals, they need a ready product to present for their innovative new drug application. Only after this IND filing can they begin the phase one clinical trials,” Choi-Rivera said.
“Earlier, when we did not offer sCMO service, our clients had to find another partner for the small batch production for IND filing, and then perhaps come back to us for a bigger batch CMO later for commercialization,” Choi-Rivera said.
Going back and forth to different facilities requires tech transfers each time, and can be time-consuming and costly for client firms.
Samsung Biologics had faced many requests from clients who sought a one-stop service. The firm is answering these requests through four 1,000-liter bioreactors at its third plant.
Two of these reactors are stainless steel and the other two are single-use plastic bag reactors.
More small-batch bioreactors are in the works for an upcoming fourth plant, for which a timeline has yet to be announced.
Regina-Choi said that there are clients who prefer single-use reactors for time efficiency, and those who prefer stainless steel for its safety against product erosion.
A hybrid facility that meets both demands is being considered, but has not been finalized.
SCMO is the critical bridge that connects CDO and CMO production. CDO covers from cell line development up to phase one clinical trials, while CMO comprises full-on commercialization batches for approved patient use.
Currently some 100 employees are devoted to the new sCMO unit, Choi-Rivera said.
WuXi Biologics and Boehringer Ingelheim are global CMO companies that are already producing 1,000-liter and 2,000-liter small-scale CMO services.
Through this “small” expansion, Samsung Biologics will be jumping into direct competition with the firms.
Samsung Biologics sources single-use materials from Merck and Saint-Gobain, both of which, according to industry sources, have been induced to enter the Korean market by Samsung.
There are currently no Korean companies that can provide single-use products that meet Good Manufacturing Practice guidelines, according to industry sources. Even globally, there are only three or four such validated companies. Samsung Biologics is currently subsidizing efforts to localize the materials.
By Lim Jeong-yeo (email@example.com
Korea Herald correspondent