Facilities & Capacity

Bavarian Nordic to validate fill/finish plant using $44m US gov option

The US Biomedical Advanced Research and Development Authority (BARDA) has exercised a second option in its smallpox vaccine contract with Bavarian Nordic. In September 2017, the US government’s Biomedical Advanced Research and Development Authority (BARDA) awarded Danish vaccine manufacturer Bavarian Nordic contract for the manufacturing and storage of its smallpox vaccine worth upwards of $539 million (€474 million). To support the agreement, BARDA exercised an option in 2017 to cover development costs associated with the Phase III study of the…

Pfizer: ‘Dropped preclinical programs do not change commitment to biosimilars’

In the latest example of a Big Biopharma reducing its biosimilar presence, Pfizer has abandoned five of its preclinical programs. The decision is part of an R&D review set to cut 150 jobs in Illinois and India. In November 2018, Bioprocess Insider reported claims that Big Pharma is set to exit from the biosimilars space over the next five years. Within weeks of publishing, Boehringer Ingelheim joined the likes of Germany’s Merck KGaA and Novartis division Sandoz in abandoning elements…

Allogene eyes cell therapy manufacturing plant in Bay area

After raising $324 million last year, Allogene Therapeutics says it is planning to construct a cell therapy manufacturing facility near San Francisco, California. Allogene Therapeutic is focused on developing allogeneic, or off-the-shelf, T cell. In October 2018, the San Francisco-headquartered firm raised $324 million (€283 million) in an initial public offering (IPO). Since its launch, the cell therapy firm has been working with a contract manufacturing organization (CMO) but now Allogene has told BioProcess Insider that it plans to build…

Lonza adding single-use capacity and 180 jobs at UK mammalian plant

Lonza will increase its mammalian process development and small-scale cGMP manufacturing capabilities through a multi-million pound investment at its Slough, UK site. Swiss contract development and manufacturing organization (CDMO) has told BioProcess Insider it is making a “multi-million pound investment” into its facility in Slough, UK. The site, located around 40km west of London, serves as Lonza’s center of excellence for mammalian biopharmaceutical process development and small-scale cGMP manufacturing, primarily for clinical phases. It also offers a range of analytical…

AstraZeneca closing two ex-Amgen CO sites, 210 jobs hit

Two Colorado facilities acquired from Amgen will be closed as AstraZeneca looks to consolidate drug substance manufacturing at its site in Frederick, Maryland. Anglo-Swedish pharma giant AstraZeneca is ending operations at its facility in Boulder, Colorado and the nearby Longmont plant less than four years after acquiring them from Amgen. The decision to shutter the sites was made as part of AstraZeneca’s biomanufacturing consolidation strategy, a spokesperson from the firm told BioProcess Insider. “AstraZeneca has made the decision to consolidate…

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

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

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

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

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…