Facilities & Capacity

Catalent commits to pDNA, buying Delphi and expanding a Maryland plant

Having its own plasmid DNA capabilities will launch Catalent into areas like mRNA and non-viral gene delivery, the CDMO says. Catalent has entered into an agreement to buy fellow contract development and manufacturing organization (CDMO) Delphi Genetics, adding – if the deal goes through – a plasmid DNA (pDNA) platform and supporting production services from preclinical to Phase III. The deal, financial details of which have not been divulged, will also bring Catalent a 17,000 square-foot facility in Gosselies, Belgium,…

CDMO to build $490m MAb plant as GSK exits UK site

Lakes BioScience has received permission to begin building a £350 million biomanufacturing facility at a site in Ulverston, UK, currently owned by GSK. Last week, South Lakeland District Council granted permission for Lakes Bioscience, a recently formed biomanufacturing firm, to build a new facility on GlaxoSmithKline’s (GSK) site located on North Lonsdale Road, Ulverston, Cumbria. Lakes BioScience director, Pat McIver told BioProcess Insider it is investing £350 million ($490 million) to build a new site which will produce monoclonal antibodies…

Emergent CDMO biz ‘thriving’ in COVID-19 environment

The COVID-19 pandemic has highlighted the growing mammalian and viral vaccines market and placed Emergent in a “leading position†in the CDMO space, says CEO Bob Kramer. The fourth quarter 2020 produced record revenues for Emergent BioSolutions, with the firm reporting sales of $583 million, up 62% on the year prior. For the full year, sales tallied $1.56 billion, up 41% on 2019. While Emergent has its own product line (contributing $340 million in the quarter, with its smallpox vaccine…

Charles River to reenter CDMO space in $875m Cognate buy

The proposed acquisition of Cognate BioServices will bring services firm Charles River Laboratories autologous and allogeneic cell therapy, plasmid DNA and viral vector manufacturing capabilities. The agreement announced yesterday will see Charles River pay $875 million in cash for the contract development and manufacturing organization (CDMO). Through the deal, Charles River has propelled itself into the manufacturing space, entering a lucrative cell therapy and plasmid production market. “The addressable market for Cognate’s CDMO services principally cell therapy and plasmid production…

Takeda to expand cell therapy facility in Ireland

Takeda has invested €36 million in its Grange Castle facility to support the expansion of its cell therapy manufacturing facility. Takeda Ireland, a subsidiary of Takeda Pharmaceutical Company, said its facility, located about 10km west of Dublin, will become the first commercial-scale cell therapy producton facility in Ireland, following the €36 million ($43 million) expansion.. “The expansion of the cell therapy manufacturing line in Grange Castle will help us to serve more patients worldwide,†a spokesperson for Takeda told BioProcess…

Resilience bags Sanofi-Genzyme plant in Boston

Newly formed CDMO Resilience takes over the once-troubled Allston facility in Massachusetts from Sanofi, retaining all 250 staff. Last November, ‘National Resilience’ – less formerly known as Resilience – raised over $800 million in funding and launched itself as a contract development and manufacturing organization (CDMO). At the time, the firm said it will provide “new, better, faster ways†to manufacture cell and gene therapies and alluded to having capacity at multiple facilities to carry out this mission. Now the…

Recipharm expands biologics offerings at German plant

CDMO Recipharm has extended its drug product manufacturing license to include immunology products, expanding its biologics offering. The license applies to the firm’s facility in Wasserburg, Germany. It covers microbiological testing which allows Recipharm to carry out bacterial endotoxin testing on its customers’ products. “Certain bacteria (gram negative bacteria) can release constituents of their cell membrane,†general manager of Recipharm’s facility, Michael Isele told BioProcess Insider. “Bacterial endotoxins can only be destroyed by dry heat exceeding 300°C. Constituents of drug…

Vigene upping viral vector capacity by 50% through Maryland facility

CDMO Vigene Biosciences has leased a 52,000 square foot facility in Maryland to support ongoing demand for viral vectors. The contract development and manufacturing organization (CDMO) has entered a lease agreement, adding a facility in Rockville, Maryland with supporting infrastructure, including HVAC and flooring and Water for injection (WFI) system in place The additional manufacturing space will complement Vigene’s nearby GMP manufacturing plant, acquired in 2016 through the purchase of assets from Omnia Biologics. The lease brings Vigene’s total lab…

Orchard Therapeutics talks the benefits of HSC therapy

Having raised $150 million, Orchard hopes to expand its therapy pipeline into larger indications and says its HSC approach is not limited to the vector it uses. The firm has said the funding will also aid the launch of gene therapy Libmeldy in Europe. Last year, the firm received approval for the one-time treatment which is used to treat children with metachromatic leukodystrophy (MLD). Though often viewed as a single technology, the delivery mechanism, the vector, and the type of…

Rentschler catapults into the cell and gene therapy space through UK investment

German CDMO Rentschler will set up manufacturing capabilities at the UK’s Cell and Gene Therapy (CGT) Catapult, launching itself into the regenerative medicine space. Family-owned contract development and manufacturing organization (CDMO) Rentschler offers mammalian manufacturing and fill and finish services for biologics but has now expanded into cell and gene therapy production through a deal with the CGT Catapult, based in Stevenage, UK. Rentschler will establish its manufacturing capabilities – including adeno-associated virus (AAV) vector production – through “a significant…