Longstanding Bio Partner Celltrion Launches Full CDMO Unit

The Korean firm, which boasts Teva and Pfizer as partners, has consolidated its third-party services to offer a full CDMO platform.

Celltrion announced at BIO in Boston last week it is launching a “Bio CDMO” (contract development and manufacturing) business. According to the South Korean biologics maker, the service consolidates its current third-party offerings, combining cell line development and production process, with clinical and commercial biomanufacturing.

Spokesperson Gunhyuk Lee told BioProcess Insider: “You could consider this CDMO business as a new consolidated platform.”

Lee added the business unit will operate from its site in South Korea, but further information has not been divulged.

Big Biopharma Partners

Celltrion has a site in Incheon, South Korea housing two biomanufacturing facilities with planned stainless steel bioreactor capacity of 190,000 L. The firm already offers third-party services, both in development and manufacturing, and has some large pharma partners on its books.

After acquiring Hospira for US$17 billion (€14.4 billion) in 2015, Pfizer inherited a partnership deal, under which Celltrion develops and produces several biosimilars, including Inflectra, a version of J&J’s Remicade (infliximab) available in both Europe and the US.

However, moving forward Celltrion is hoping to up its third-party services for originator biologics with Lee telling us: “We are currently focusing to develop and secure new novel drug pipelines.”

Celltrion is contracted to make the active ingredient of Teva Pharmaceutical Industries’  fremanezumab, a novel humanized monoclonal antibody targeting calcitonin gene–related peptide (CGRP). A US Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) action date is set for September 16, postponed following regulatory issues at Celltrion’s fill and finish plant at the Incheon site.

Celltrion received an FDA warning letter in January citing poor aseptic behavior and media fill deficiencies. The letter led to the FDA rejecting the approval of biosimilar versions of Rituxan (rituximab) and Herceptin (trastuzumab) made at the site in April. Both biosimilars, once approved, will be commercialized in the US by Teva under a partnership forged in 2016.