Deal-Making

Catalent to provide large-scale fill/finish for J&J coronavirus vaccine project

Catalent, the latest CDMO to support Johnson & Johnson’s COVID-19 vaccine candidate, will carry out aseptic vial filling and packaging from its site in Bloomington, Indiana. Johnson & Johnson (J&J) began working on its vaccine strategy to combat COVID-19 – caused by the novel coronavirus (SARS-CoV-2) – in early January, identifying last month a lead candidate and two backups based on Janssen’s AdVac viral vector and PER.C6 cell line technology. As the programs move towards the clinic, J&J has been…

Pierre Fabre offloading MAb plant as it moves away from contract manufacturing

French drugmaker Pierre Fabre says contract manufacturing is not a priority as it looks to sell two facilities to CDMO Fareva. The two facilities Pierre Fabre is hoping to offload are an oncology injectable plant in Pau, and a monoclonal antibody production plant in Saint-Julien-en-Genevois, both in France. Both have been making products for others. Pierre Fabre focus is not on being a contract development and manufacturing organization (CDMO), said spokesperson Valérie Roucoules and so the decision to sell the…

Fujifilm licenses AAV vector tech to speed gene therapy production

CDMO Fujifilm Diosynth Biotechnologies (FDB) says partnering with OXGENE could reduce the lead time of its customers’ gene therapy projects by up to 25%. The technology, licensed from UK-based OXGENE for an undisclosed fee, consists of Helper, Rep/Cap and Gene of Interest plasmids, used in combination with a clonal suspension a HEK293 cell line. The AAV system is expected to reduce the length of the supply chain gene therapy customers, according to contract development and manufacturing organization (CDMO) FDB, with…

Evotec extends Takeda pact to gene therapy

Evotec is building a gene therapy R&D center manned by ex-Takeda scientists and has already landed a multi-year drug discovery pact for it with their former Japanese employer. Evotec is expanding into the field of gene therapy by building an R&D center in Austria using scientists previously employed by Takeda, whose first project will be a long-term research and discovery project with their former Japanese employer, exploring oncology, rare diseases, neuroscience and gastroenterology. The entry by the German discovery alliance and…

Sanofi and GSK will use Flublok and AS03 tech to make coronavirus vaccine

Sanofi is aiming to manufacture hundreds of millions of doses of the coronavirus (SARS-COV-2) vaccine it is working on with GSK and BARDA and is targeting a late 2021 launch. Sanofi and GSK announced the deal on Tuesday, explaining they signed a letter of intent and a materials transfer agreement to assess the technical path to develop and produce a COVID-19 pandemic vaccine. Sanofi spokeswoman Marion Breyer said “Our goal is to initiate Phase I clinical trials in the second…

Orgenesis signs muscle-derived stem cell pact with Revatis

Orgenesis has added muscle-derived stem cells to its offering through a manufacturing joint venture with Revatis. The partnership will supply developers of autologous cell therapies with exosomes and other cellular products obtained from muscle-derived mesenchymal stem cells (mdMSCs). The firm told us “The objective is to spin-off Revatis technology developed in the vet field into the human field; the JV  is currently planned to be  called “REVACEL. “After technology transfer, REVACEL will conduct development of muscle derived MSCs first and then as sourcing of…

Vir and GSK add CDMO Samsung Bio to COVID-19 MAb program in $362m deal

Speed and mass production capacity are key when manufacturing potential COVID-19 treatments, says Samsung Biologics as it becomes the latest CDMO to support Vir’s SARS-CoV-2 monoclonal antibody programs. Vir Biotechnology has a technology that identifies antibodies in people who are protected from, or who have recovered, from infectious disease. The firm is using this platform to tackle the novel coronavirus, and has partnered with GlaxoSmithKline (GSK) to bring lead candidates VIR-7831 and VIR-7832 through the clinic. The company says both…

Establish gene therapy tech early says Daiichi as it inks Ultragenyx deal

Daiichi Sankyo has licensed a commercial-scale gene therapy manufacturing technology from Ultragenyx Pharmaceutical in a $200m deal. The Japanese firm will use Ultragenyx’s HeLa producer cell line and HEK293 transfection system for adeno-associated virus (AAV) manufacture in its gene therapy development programs. Masayuki Yabuta, head of Daiichi’s biologics division, set the deal as part of a wider investment in the firm’s gene therapy business. “In order to provide these drugs to patients in the future, manufacturing technology must be established…

Allogene turns to MaxCyte’s tech for its off-the-shelf CAR-T therapies

MaxCyte says its clinically validated electroporation technology will help increase efficiency and improve yield of Allogene’s allogeneic CAR-T therapy candidates. Pfizer-backed biotech Allogene launched in 2018 with a focus on developing allogeneic, or off-the-shelf, chimeric antigen receptor (CAR) T-cell therapies. To achieve this, the firm has regularly stressed the importance of manufacturing, devoting “considerable time and resources” to the process. Now the firm has inked a deal to use MaxCyte’s ExPERT platform to develop and advance its candidates through to…

J&J to expand vaccine capacity as part of $1bn BARDA coronavirus collaboration

Johnson & Johnson (J&J) says it will leverage and expand facilities in The Netherlands and Pennsylvania in efforts to reach one billion doses of a potential COVID-19 vaccine. In February, J&J teamed up with the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services (HHS) to develop a vaccine against the novel coronavirus (COVID-19). At the time the company said it would work to upscale production and manufacturing capacities, leveraging its AdVac and PER.C6…