Lonza, Celltrion Partner; SK To Launch US-HQ API Ops; Catalent To Expand

By Emily Forster -

September 5, 2019

The latest news from CDMOs, CMOs, and suppliers, featuring news from SK, Lonza, Catalent, and Velesco Pharma.

Chemicals/Chemical API Manufacturing

SK Holdings To Launch CDMO Business With New Identity in January

SK Holdings, the holding company of South Korea’s SK Group, has announced that it will launch a new identity for its contract development and manufacturing organization (CDMO) business, effective January 2020. The move involves a governance restructuring, which will be completed by the end of 2019, that combines SK biotek in Korea and SK biotek in Ireland, along with Ampac Fine Chemicals in the US, to form SK Pharmteco, the consolidated entity, whose name has yet to be determined. The business will be led by Aslam Malik, now Chief Executive Officer of Ampac, with headquarters in Sacramento, California.

SK has built its CDMO business through two recent acquisitions. In 2018, the company acquired Ampac Fine Chemicals a Rancho Cordova, California-headquartered contract manufacturer of active pharmaceutical ingredients (APIs) and intermediates. Its operations are located in Rancho Cordova and El Dorado Hills, California; La Porte, Texas; and Petersburg, Virginia.

In January 2018, SK biotek, the life-sciences arm of SK for custom chemical development, advanced intermediates and API manufacturing, completed its acquisition of a former Bristol-Myers Squibb (BMS) API manufacturing facility in Swords, Ireland. The transaction included the transfer of approximately 350 BMS employees to SK and the addition of the 21-acre site with 82 cubic meters of reactor capacity.

In addition to the Swords facility and the facilities of Ampac Fine Chemicals, SK’s CDMO business includes two production facilities, respectively in Sejong and Daejeon, South Korea.

Source: SK Holdings

Biologics Manufacturing

Lonza, Celltrion Partner for Manufacturing of Remicade Biosimilar

Celltrion, an Incheon, South Korea-based developer of biosimilars and biologics, and Lonza have formed a contract manufacturing agreement to produce the drug substance for Remsima, a biosimilar of Johnson & Johnson’s Remicade (infliximab), a drug to treat a number of autoimmune diseases, including Crohn’s disease and rheumatoid arthritis.

The Remsima drug substance will be produced in Lonza’s commercial facility in Singapore to cover market needs in Europe and North America. Over the first quarter of 2019, the two companies worked together on the validation process at Lonza’s Singapore manufacturing facility and have submitted the products produced there for approval by the European Medicines Agency. Continuing the collaboration, the two companies say they will also seek US Food and Drug Administration approval.

Celltrion’s partnership with Lonza complements its existing capacity of 190,000 liters of drug substance per year from two plants in South Korea.

Source: Lonza

Formulation Development/Drug Product Manufacturing

Velesco Pharma To Triple Clinical Mfg Capacity With New Michigan Facility

Velesco Pharma, a contract analytical and formulation services provider, is tripling its clinical manufacturing capacity with the purchase and fit-out of a new facility in Wixom, Michigan.

The new building will feature expanded processing suite space for cGMP clinical trial material capabilities. This facility will be supported by Velesco Pharma’s existing release and stability testing laboratory also located in Wixom. It will replace and consolidate the company’s existing manufacturing site in Kalamazoo, Michigan.

Velesco Pharma supports early- and later-stage drug development through contract analytical and drug formulation services, along with cGMP clinical supplies of non-sterile dosage forms.

Source: Velesco Pharma 

Packaging

Catalent To Invest $9 Million in New Clinical Supply Facility in San Diego

Catalent has announced that it plans to invest $9 million in a new clinical supply facility in San Diego, California, due to open in the summer of 2020.

The new 24,257-square-feet facility will offer full clinical supply services and specialize in services for early-phase clinical trials. Its capabilities will include clinical supply management, primary and secondary packaging, complex labeling services, clinical storage, distribution, and drug returns and destruction, and will include stability chambers.

The company has a network of more than 50 depots as well as sites in the US, the UK, Germany, Singapore, Japan and China.

Catalent’s existing San Diego facility is one of three global centers of excellence in oral dose early-phase development focusing on preclinical to clinical Phase IIb formulation, analytical, and manufacturing solutions for orally delivered small molecules; the other two are in Somerset, New Jersey and Nottingham, UK.

Source: Catalent