Samsung Biologics and TG therapeutics have expanded their existing contract to manufacture Ublituximab, a monoclonal antibody drug to treat multiple sclerosis. Korean Contract development manufacturing organization (CDMO) Samsung Biologics and US-based firm TG Therapeutics have expanded their 2018 contract to produce TG’s ublituximab (TG-1101), a monoclonal antibody (mAb) that targets an epitope on CD20-expressing B-cells. Samsung Biologics did not divulge ublituximab’s manufacturing process due to client confidentiality. However, a spokeswoman for the firm told BioProcess Insider it will “offer large-scale…
Deal-Making
Avectas to develop cell engineering technology for CGT space
Avectas has received funding to develop a cell engineering technology platform to manufacture ‘off-the-shelf’ cell therapies for cancer treatment. Irish cell engineering firm Avectas is leading a project in partnership with the National Institute for Bioprocessing Research and Training (NIBRT) and Bluebridge Technologies, which will invest $8.7 million – including $5.3 million awarded by the Irish Government’s Disruptive Technology Innovation Fund (DTIF) – to develop the cell engineering platform Solupore. “Solupore is a comprehensive end-to-end cell engineering platform that comprises…
Sanofi to fill-finish up to 200m doses of Moderna’s COVID vaccine
Sanofi will supply fill-finish services for up to 200 million doses of Moderna’s COVID-19 vaccine mRNA-1273. French pharma giant Sanofi will use its site in Ridgefield, New Jersey to support manufacturing of Moderna’s cell-free COVID-19 vaccine, 1273, approved under Food and Drug Administration (FDA) emergency authorization. According to the firm, it could help manufacture up to 200 million doses of the COVID-19 vaccine starting from September 2021 through to April 2022. “While our utmost priority remains to advance our two COVID-19 vaccine…
Ins & outs: High level leadership changes at Novavax
Novavax has switched up its leadership with multiple changes. Meanwhile there are changes at Kyverna and Precision BioSciences. Put your feet up and enjoy BioProcess Insider’s Ins & Outs. US-based biotechnology company Novavax develops and commercializes various vaccines to treat infectious diseases such as Ebola, seasonal influenza, and COVID-19. The firm has its own COVID-19 vaccine candidate, NVX-CoV2373, which has not yet received approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and is currently in two Phase III…
CDMO round-up: News from Lonza, MedPacto and Revolo Biotherapeutics
Lonza collaborates with Immunitas to develop candidate; MedPacto signs agreement with Samsung Biologics; Revolo Biotherapeutics chooses CordenPharma to manufacture its peptide and immune system resetting drug candidate. Great to have you here for Bioprocess Insider’s CDMO round-up. First up in our contract development manufacturing organization (CDMO) round-up is Lonza, which recently entered an agreement with Immunitas Therapeutics to support manufacturing of Immunitas’ lead program, IMT-009. IMT-099 is a monoclonal antibody that suppresses NK cells and T cells in the tumor microenvironment and…
Thermo Fisher to buy PPD to build in ‘high growth’ clinical services sector
Thermo says buying PPD will position it as leader in the “high growth†CRO sector and help it win more business from new and existing customers. Thermo Fisher Scientific announced its intention to buy contract research organization (CRO) PPD for $17.4 billion in a statement on Thursday, citing demand from pharma and biotechnology sector customers. Thermo Fisher’s CEO Marc Casper said “The acquisition of PPD is a natural extension for Thermo Fisher and will enable us to provide these customers…
Ori and ATMPS team to lower advanced therapy COGS through blockchain
ATMP’s blockchain-based data sharing platform will be incorporated into Ori Biotech’s cell and gene therapy manufacturing platform. ATMPS, a spin out from Farmatrust, created the Hataali platform to record scheduling and ordering data for advanced therapy treatments within a blockchain system that enables secure and confidential sharing of data between partners. Ori Biotech, a developer of automated and scalable cell and gene therapy (CGT) manufacturing systems, has partnered with ATMPS in efforts to provide improved product tracking, scheduling as well…
Roche secures space at Novartis plant as COVID drives Actemra demand
In the latest example of pandemic-related collaboration, Novartis is prepping to make the drug substance for Roche’s Actemra (tocilizumab), currently being investigated as a treatment for severe COVID-19-associated pneumonia. Novartis has signed an initial agreement with fellow Swiss pharma giant Roche to reserve capacity and implement a tech transfer for the drug substance production of Actemra (known as RoActemra in Europe) from its site in Tuas, Singapore. Actemra, a monoclonal antibody first approved in the US for rheumatoid arthritis (RA)…
Ins & outs: Cavazzoni named as director of FDA’s CDER
The US FDA’s CDER  has named Patrizia Cavazzoni as its permanent director. Meanwhile, there are high level changes at Rentschler Biopharma, Bone Therapeutics, and Imvax. Sit back, relax, and enjoy BioProcess Insider’s Ins & Outs. The appointment comes after Cavazzoni has served as acting director of the US Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER) for the past year after Janet Woodcock stepped away from the role to assist Operation Warp Speed (OWS) in response to…
Lonza to make Junshi Biosciences antibody at China facility
Lonza has expanded its collaboration with Junshi Biosciences to develop and manufacture an antibody candidate at its recently opened, Guangzhou facility. Swiss contract development manufacturing organization (CDMO) Lonza has extended its partnership with Chinese firm Junshi Biosciences to advance and manufacture biologics. The agreement also includes the production of an antibody candidate that will be manufactured at Lonza’s site in Guangzhou, China. Under the agreement, Lonza will provide support to develop and manufacture current and future antibody-based products in Junshi…