Facilities & Capacity

Series A funding to expand Wheeler Bio OK drug substance plant

Wheeler Bio has closed a Series A financing round, which it says will fund the expansion of its biologics drug substance facility in Oklahoma. Wheeler Bio, a contract development and manufacturing organization (CDMO) that uses its open-source platform, Portable CMC, to produce clinical batches of biologics and reagents says the financing round, led by Charles River Laboratories and various others, will expand its facility in the Ziggurat building in Oklahoma City. According to the CDMO, it is solving “the momentum drop”…

MilliporeSigma opens €50m France antibody production plant

The facility in Martillac will make commercial monoclonal antibody drug substance up to 2,000 L and is part of a wider MilliporeSigma investment in France. In June 2021, MilliporeSigma – the life sciences division of Germany’s Merck KGaA – announced plans to invest €175 million ($174 million) and create 500 jobs at its sites France. As part of that, a €50 million facility has opened its doors, adding a 2,700 square-meter single-use drug substance plant at the Martillac site, south…

Kite receives US FDA nod for California viral vector plant

The US FDA has approved Kite’s retroviral vector manufacturing plant in Oceanside, California for commercial production. According to Gilead company Kite Pharma, the authorization received from the US Food and Drug Administration (FDA) concerning its retroviral vector (RVV) facility in California supports its worldwide chimeric antigen receptor (CAR) T-cell therapy production network and helps meet demand of the firms’ blood cancer treatments. “With today’s approval, we’ll begin transitioning viral vector supply to our inhouse Oceanside manufacturing facility, while maintaining our…

Modular systems make facility delivery fast, says Tenaya

Scott Bertch from heart disease gene therapy developer Tenaya Therapeutics told BWB delegates modular systems have the ability to accelerate facility delivery. When thinking of gene therapies “manufacturing is one of the biggest problems,” Bertch, executive director, clinical manufacturing site head at Tenaya Therapeutics told delegates at the BPI conference, part of Biotech Week Boston 2022. While there are pros and cons associated with both inhouse and outsource manufacturing models (Tanaya has previously spoken positively about the former for cell…

MilliporeSigma opens its first viral clearance lab in China

MilliporeSigma has completed the first construction phase of its China Biologics Testing Center, opening a viral clearance (VC) laboratory in Shanghai. MilliporeSigma, the life sciences division of Merck KGaA, says the 5,000 square meter center is the “first of its kind” for the firm in China. And according to the company, the $28 million VC laboratory helps meet the double-digit demand for VC services in the country as it enables its customers to locally conduct viral clearance studies from pre-clinical…

Fujifilm breaks ground at microbial plant in UK

Fuljifilm Diosynth Biotechnologies has started the expansion of its large-scale microbial manufacturing plant located in Billingham, UK. The company confirmed in December 2021 that £400 million ($443 million) of a previously announced investment would be spent expanding its contract development manufacturing organization (CDMO) operations in Billingham. Now, Fujifilm has broken ground at the location and says it will include over 20,000 square feet of modular clean room space, as well as two purification suites, a column packing room, refolding suites,…

Catalent hit with FDA 483 at Bloomington plant

A US FDA Form 483 has revealed visible foreign particles in certain batches of drug product at Catalent’s Bloomington, Indiana facility. The Bloomington plant, which offers fill and finish services and commercial scale production, was handed a Form 483 from the US Drug and Food Administration (FDA) following an inspection at the facility between August 1 and September 1. The 483 detailed that the FDA identified 179 occasions where particles, like black specks, foreign matter, particular matter, and foreign objects…

MeiraGTx opens first commercial-scale gene therapy plant in Ireland

MeiraGTx has opened what it claims is the first commercial-scale gene therapy manufacturing site in Shannon, Ireland. Clinical stage gene therapy firm MeiraGTx Holdings has “unveiled” its 150,000 square-foot production facility in Shannon, Ireland with Micheál Martin, the Head of the Irish Government in attendance. “The plasmid facility has been operating actively since early this year and is now reaching a level of maturity to achieve full GMP standard and application for commercial licenses,” a spokesperson for the firm told…

AbCellera continues antibody scale-up at Vancouver plant

AbCellera has begun the second phase of expansion at its Vancouver, Canada plant aimed at supporting antibody demand from its biopharma partners. According to the firm, the 380,000 square-foot site will support AbCellera’s capabilities to develop antibody-based medicines to the clinic. “We have already developed a world-leading antibody discovery engine that finds optimal clinical antibody candidates for our partners,” Murray McCutcheon, senior vice president corporate development at AbCellera told BioProcess Insider. “The second phase of our expansion will extend those…

Celyad plant buy to accelerate growth for cell therapy CDMO Cellistic

Cellistic has agreed to buy Celyad Oncology’s capabilities in Mont-Saint-Guibert, Belgium to support its “rapidly growing” allogeneic iPSC manufacturing business. The deal will see Cellistic, the cell therapy contract development and manufacturing organization (CDMO) business of Ncardia BV, add the 11,000 square-foot facility located in Mont-Saint-Guibert – around 25km southwest of Brussels – from CAR-T developer Celyad. The site achieved GMP approval back in 2012 when Celyad was known as Cardio3 BioSciences. “The purchase price for the assets in the…