Facilities & Capacity Archives - Page 62 of 73 - BioProcess InternationalBioProcess International

Third Korean plant with 120,000L capacity back on for Celltrion

Celltrion has confirmed its third biomanufacturing plant will be constructed in Korea after assessing locations overseas. The facility will have 120,000 L of biologics capacity. Seo Jeong-jin, chairman of Korean drugmaker Celltrion, told investors at last year’s JP Morgan Healthcare Conference that plans laid down in 2016 to build a third biomanufacturing facility at its site in Songdo, Incheon had been scrapped in favor of a much larger facility overseas. But a year on and Celltrion has announced a U-turn.…

Fujifilm pumps $111m into its US biologics and stem cell network

by Dan Stanton

Fujifilm Corporation will increase capacity at its North Carolina CDMO site to feed demand for mammalian and microbial manufacturing. The firm is also opening a $21m induced pluripotent stem (iPS) cell plant in Wisconsin. Fujifilm Diosynth Biotechnologies (FDB), a contract development and manufacturing organization (CDMO) division of Japan’s Fujifilm Corporation, plans to invest JPY 10 billion ($90 million) into its site in Morrisville, North Carolina. “This expansion is driven by continued demand for our manufacturing capability given that our customer’s…

Avid: Balancing MAb capacity with industry’s growing needs

by Dan Stanton

Monoclonal antibody (MAb) capacity remains roughly in balance with industry’s needs but firms should look to procure manufacturing services early to guarantee their projects, says CDMO Avid Bioservices. Twelve months ago, Peregrine Pharmaceuticals sold its internal monoclonal antibody (MAb) programs and became a pure contract development and manufacturing organization (CDMO) under the Avid Bioservices title. The CDMO has GMP facilities in Orange County, California offering biopharma firms both stainless steel and single-use biologics manufacturing services. As such, the firm spoke to…

Up titer: WuXi breaks 50g/L with continuous CHO process

by Dan Stanton

WuXi Biologics has achieved cell culture productivity for an Fc-fusion protein of 51 g/L and is confident it can be scaled up to 4,000 L. Single-use bioreactors are limited to 4,000 L in capacity (though many biomanufacturers put 2,000 L as their upper limit). Using these bioreactors with mammalian cell line tech is problematic for large-scale commercial use due to the generally low productivity of such expression systems, usually sub-10 g/L. But Chinese contract development and manufacturing organization (CDMO) WuXi…

Novartis bids to buy its French CAR-T CDMO

by Dan Stanton

Novartis has made an offer to buy its manufacturing partner CELLforCURE. If accepted, Novartis will add a facility in Les Ulis, France to its CAR-T network. Novartis announced it was working with CELLforCURE in July, transferring its chimeric antigen receptor (CAR) T-cell production technology to the French contract development and manufacturing organization (CDMO) from its site in Morris Plain, New Jersey. Less than six months on, the Swiss pharma giant has made an offer to buy “the share capital of…

Rentschler buying Shire hemophilia plant in MA

by Dan Stanton

Rentschler Biopharma will produce recombinant hemophilia A product Obizur for Shire after acquiring the Milford facility. German contract development and manufacturing organization (CDMO) Rentschler has entered into an agreement to buy Shire’s Milford, Massachusetts manufacturing facility. The facility makes Shire’s approved product Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence], and under terms of the deal Rentschler will take over production and supply directly to Shire from the plant. Financial details have not been disclosed. “Milford is a specialized site that focuses…

Global biologics demand driving MabPlex expansions

by Dan Stanton

MabPlex has opened a facility in Yantai, China with up to 24,000 L of single-use capacity to serve the growth in biomanufacturing demand. MabPlex International, a contract development and manufacturing organization (CDMO) focused on monoclonal antibodies and antibody-drug conjugates (ADCs), has expanded its global offering through the opening of a commercial plant in Yantai, China. The ribbon cutting ceremony took place in September and according to the firm, the expansion helps feed the global demand in biologics services. “The demand…

Manufacturing shutdowns and idle capacity mar Avid’s Q2

by Dan Stanton

Business is up and proposal requests are increasing, but planned sequential maintenance shutdowns of both Avid’s manufacturing facilities hit the CDMO’s second quarter revenues. For the second quarter FY19, Avid Bioservices reported manufacturing revenue of $10.2 million (€9 million), down 20% on the same period last year. The firm – which became a pureplay contract development and manufacturing organization (CDMO) in January 2018 – attributed the drop to planned sequential maintenance shutdowns of both its Californian production plants. The Franklin…

Pfizer Kansas plant hit by FDA 483 with 8 repeat observations

by Dan Stanton

The US FDA observed potential mold contamination and deficient aseptic processes during an inspection at Pfizer’s fill/finish facility in McPherson, Kansas. The McPherson facility was one of several manufacturing plants added to Pfizer’s network following the $17 billion (€14.9 billion) acquisition of Hospira in 2015. The plant has been subject to various regulatory issues, resulting in a US Food and Drug Administration (FDA) warning letter in February 2017 citing poor aseptic processing and repeat GMP violations. An October 2017 inspection resulted…

Lonza to biomanufacture in China with a little help from GE

by Dan Stanton

Changing policies in China bring opportunities for foreign CDMOs says Lonza, which is opening a biologics facility in Guangzhou, supported by GE Healthcare. Swiss contract development and manufacturing organization(CDMO) Lonza has announced it is constructing its first biomanufacturing facility in China. The 17,000 m² plant will be based on GE Healthcare’s off-the-shelf modular biologics factory, KUBio platform, and will supply antibody drugs to the local market. “We do have an established presence in China and in theGuangzhou district but this…