Author Archives: Millie Nelson

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,…

Polyplus bolsters mRNA portfolio with LNP-alternative reagent

Polyplus has launched an in vivo-jetRNA transfection reagent, which uses a preformed liposome to support and expand its messenger RNA (mRNA) portfolio. Polyplus, a French biotech firm focused on providing biologic and cell and gene therapy research and production, says its in vivo-jetRNA transfection reagent is efficient, stable, and offers a safe delivery system alternative to lipid nano-particle (LNP) delivery. “Non-viral mRNA delivery methods have already proven their efficiency in vaccination through antigen presenting cell modification and in anti-cancer therapy…

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…

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…

Forge Bio bags $90m funding to expand CGT capabilities

CDMO Forge Biologics has completed a $90 million Series C financing round, which will be used to expand its technologies, manufacturing systems, and cell lines. The gene therapy contract development manufacturing organization (CDMO) Forge Bio has raised $90 million with finances led by Aisling Capital, Drive Capital, and an undisclosed strategic investor. According to the CDMO, it will expand the number of its service offerings available to customers in order to scale its gene therapy programs from research to clinical…

Biden pledges $2bn to launch US biomanufacturing initiative

The US government will invest over $2 billion to launch its biomanufacturing initiative, which aims to expand manufacturing capacity in the country and ensure pandemic preparedness. The Executive Order was signed by President Biden on Monday and outlines the key goals of the biomanufacturing initiative. Overall, the Order looks to strengthen the country’s supply chain in the biopharma space and to reduce reliance on foreign manufacturing for the drug industry. Biden said it is the policy of his Administration to…

Beckman Coulter bolsters analytical capabilities with ValitaCell buy

Beckman Coulter Life Sciences has acquired ValitaCell, an analytical technologies and product provider for the biopharmaceutical industry. Under the terms of the deal, US-headquartered laboratory and automation firm Beckman Coulter Life Sciences — a subsidiary of Danaher Corporation, which owns bioprocess vendors Cytiva and Pall — has bought Dublin-headquartered ValitaCell for an undisclosed fee. ValitaCell has an aim of decreasing the cost of therapeutics and the time it takes to get to market. And according to ValitaCell, its ValitaTiter product…