Facilities & Capacity

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…

Lonza ups ADC capabilities with Visp expansion

CDMO Lonza has added development and manufacturing capacity for antibody-drug conjugate (ADC) payloads at its Visp, Switzerland facility. Contract development manufacturing organization (CDMO) Lonza has completed the expansion of its Highly Potent API (HPAPI) multipurpose site in Visp, which will support the full development and production pipeline from studies to commercial supply of ADC payloads. “Lonza’s expanded multipurpose suite enables customers to meet the growing demand for targeted cancer treatments by developing and manufacturing ADC payloads with increased speed, capacity…

Takeda invests nearly $300m to expand Belgium plasma-derived therapy site

The close to $300 million expansion will include a manufacturing facility and a carbon net-zero emissions warehouse in Lessines, Belgium, says Takeda. The firm announced its biggest investment to date in Belgium during the 50th anniversary celebration at its manufacturing facility in Lessines and according to Takeda, the investment signals the importance of Belgium as a location for the worldwide production and distribution of plasma-derived therapies. “Takeda is building on an 80+ year pioneering legacy in producing plasma-derived therapies. The…

Rubius weighs up RI plant sale as part of pipeline restructure

Rubius Therapeutics will also cut 75% of its staff as it discontinues its solid tumor programs in favor of developing a next-generation red blood cell-based cell conjugation platform. Massachusetts-based Rubius announced yesterday it is scrapping clinical programs RTX-240 and RTX-224 for solid tumors and instead focusing on improving the efficacy of the tech platform they were based on. “Following careful review of recent technical progress in an alternative format for making Red Cell Therapeutics, we believe that this process has…

Novartis looks beyond mAbs with $270m manufacturing spending spree

Novartis is making a multi-year investment across three European manufacturing sites to support a growing early-stage pipeline of next-generation biologics. Pharma giant Novartis announced the investments this week, with facilities in Switzerland, Slovenia, and Austria set to see increased drug substance and drug product capabilities. Specifically, $110 million will be injected in clinical manufacturing and technical development capabilities at the firm’s Mengeš, Slovenia site, while $60 million will be used to add technical manufacturing capacity at the Schaftenau campus in…