Facilities & Capacity Archives - Page 64 of 73 - BioProcess InternationalBioProcess International

Catalent pumping $200m into biomanufacturing expansions

Catalent plans to double fill/finish capacity at its Bloomington site and add a fourth and fifth train at its Madison drug substance facility. During its fourth quarter FY2018 call, contract development and manufacturing organization (CDMO) Catalent said it was eyeing up a fourth and fifth biomanufacturing train at its Madison, Wisconsin plant. And during its Q1 FY2019 investor call, CEO John Chiminski confirmed the board has approved both the expansion in Madison and a doubling of capacity at its Bloomington,…

Singapore swing: Lonza transfers Tracon Ab to single-use plant

by Dan Stanton

CDMO Lonza has produced the first 2,000 L batch of Tracon Pharmaceuticals’ antibody TRC105 from its Singapore facility after transferring production from the UK. Californian biopharma firm Tracon has been using Swiss contract development and manufacturing organization (CDMO) Lonza for the manufacture of its lead candidate TRC105 (carotuximab) since the pre-clinical phase of development. The candidate is an antibody to endoglin – a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel…

Astellas invests $256m in Japanese and US antibody and cell therapy sites

by Dan Stanton

Astellas says it is responding to the supply needs of future pipeline by constructing two multi-modality Japanese sites and relocating a regenerative medicine plant in Massachusetts. Both R&D and manufacturing are being looked at through the expansion of sites in Toyama and Tsukuba, Japan, and Massachusetts, US to progress the development and commercialization of Astellas’ portfolio. “Astellas is responding to the progress being made in the development and launch of new drugs from its existing portfolio and pipeline,” a spokesperson…

GSK to ramp-up Shingrix vaccine as demand outstrips supply

by Dan Stanton

GSK says it is pleased with the launch of its shingles vaccine Shingrix but supply going forward is limited by a lack of manufacturing capacity. In October 2017, GlaxoSmithKline received approval from the US Food and Drug Administration (FDA) for Shingrix (Zoster Vaccine Recombinant, Adjuvanted), its non-live, recombinant subunit vaccine for the prevention of shingles (herpes zoster). A year on, the Big Pharma firm announced Shingrix sales of £286 million ($372 million) for its third quarter, helping to boost its…

Biocon investing $200m into second MAb plant in India

by Dan Stanton

Construction is under way on a hybrid biomanufacturing plant at a site in Bangalore, set to support Biocon’s growing monoclonal antibody (MAb) portfolio. Indian drugmaker Biocon has a growing pipeline of biological products, including Ogivri, the first biosimilar of Roche’s Herceptin (trastuzumab) to be approved by the US Food and Drug Administration (FDA) last December, and Fulphila, the first US biosimilar of Amgen’s cancer drug Neulasta (pegfilgrastim), approved in June. Both are marketed by Mylan, but including products developed in…

Avid to triple process dev capacity on early-stage demand

by Dan Stanton

Since becoming a pure-play CDMO, Avid Bioservices says it is experiencing growing demand for process development services and has begun expanding capabilities at its site in California. At the turn of the year, Avid Bioservices became a pure contract development and manufacturing organization (CDMO) by selling off its internal monoclonal antibody programs to Oncologie and dropping its Peregrine Pharmaceuticals nametag. To grow the business further, Avid has begun a project to expand its process development services by adding 6,000 square feet…

Deal-making digest: IDT’s $80m US contract, WuXi’s strategic partership

by BPI Staff

The US National Institutes of Health (NIH) has awarded IDT Biologika a ten-year contract to make biologics and vaccines worth up to $80 million. IDT Biologika has been contracted by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) – an agency of the United States Department of Health and Human Services – to provide process development, manufacturing and characterization of vaccine and biologic products. The German drug and vaccine maker will receive…

Merck & Co. pumping up to $16bn into biomanufacturing

by Dan Stanton

Merck & Co. has upped its capital expenditure plans through 2022 to increase manufacturing capacity in areas including oncology and vaccines. At the beginning of the year, tax changes in the US led to a wealth of potential investment promises by Big Pharma looking to benefit from lower corporate rates and to repatriate cash from overseas. Merck & Co. (known as MSD outside North America) was one such firm, and in its February earnings call it announced plans to invest…

Janssen closing in on ‘holy grail’ through $82m HIV vaccine plant

by Dan Stanton

Janssen has opened a single-use manufacturing facility in Leiden, the Netherlands to support the commercialization of its preventative HIV vaccine candidate. Commissioned in 2014, the multipurpose vaccine production facility is being inaugurated today (Thursday October 25) in Leiden, the Netherlands and will initially be used to manufacture the firm’s investigational mosaic HIV-1 preventive vaccine. The facility represents an investment of €72 million ($82 million). The facility came about following the 2014 Ebola outbreak in West Africa, Dirk Redlich, VP of…

Thermo Fisher services biz up 28% as Patheon enters the mix

by Dan Stanton

Construction is underway at the ‘largest outsourced single-use site in North America’ says Thermo Fisher, a year after acquiring CDMO Patheon. In April 2018, Thermo Fisher Scientific announced a $50 million (€44 million) expansion at a plant in St Louis, Missouri to add 16,000 L of single-use capacity. The facility is run by contract development and manufacturing organization (CDMO) Patheon, acquired by Thermo Fisher in August 2017 for around $7.2 billion. And during a Q3 financial call, Thermo Fisher CEO…