Samsung BioLogics makes CMO even easier

SAN FRANCISCO - Samsung BioLogics is boosting its new small-scale contract manufacturing organization (sCMO) business as it maintains a focus on contract manufacturing in general.

The company said Tuesday during a press conference in San Francisco at the J.P. Morgan Healthcare Conference that it plans to expand facility investment in its sCMO business unit, which was formed in October.

“The sCMO business unit acts as a bridge to large-scale CMO projects,” said Regina Choi-Rivera, head of the sCMO business unit at Samsung BioLogics.

“Growing this unit is key as it serves as a midpoint and provides a smooth transition period for our clients who started with a contract development organization (CDO) project and could potentially sign up for a CMO partnership.”

In the CDO business, the company offers contract production and assistance for drug development through to the filing of applications to health authorities for the start of clinical trials.

Once accepted, Samsung BioLogics clients can sign up for a CMO project that will entail producing large quantities of drug candidates for clinical trials and commercialization.

With sCMO, just enough volume of drugs can be provided for contracted biopharmaceutical companies to apply for the start of clinical trials.

Phase 1 trials usually require a small quantity of material for production, as candidate therapies are distributed to only a handful of people for small-scale initial evaluation.

“We are essentially trying to capture clients in the earlier stage of the biopharm life cycle,” Choi-Rivera said.

They use 1,000-liter equipment “and choose if they would like to scale up and use our CMO facility.”

Samsung BioLogics is mainly focused on CMO capability at the moment, and its CDO and sCMO business units are in place to serve as a starting point for clients.

Of the 364,000-liter-capacity Samsung BioLogics has at its three plants in Incheon, the sCMO business utilizes just 4,000 liters, two 1,000-liter stainless steel platforms and two single-use systems of 1,000 liters.

Choi-Rivera said the quantity will be expanded in the future, although the company has yet to decide how much of the extra capacity will be committed to each platform.

Traditional stainless steel equipment is often used as it makes it easier for clients to scale up and prepare for large-quantity production. The single-use platform, which involves manufacturing of smaller batches using disposable equipment, has been gaining popularity within the biopharmaceutical industry, as some companies see the system as a means to reduce uncertainties and spend less on maintenance.

BY KO JUN-TAE [ko.juntae@joongang.co.kr]