Emergent Biosolutions says higher demand for CDMO services for COVID-19 related products helped it in the first quarter. Emergent total saw revenues of $192.5 million in Q1, a slight increase over 2019. The firm said total revenues reflect a decline in product sales partially offset by an increase in CDMO and contracts and grants revenues. The firm also maintained its full year guidance – revenues of $1.175 billion to $1.275 billion and net income in the $169 million to $210…
AstraZeneca plans to leverage its global network to support production of an adenovirus vaccine vector (AAV) currently in Phase I trials against COVID-19. Based on an adenovirus vaccine vector (AAV) and the SARS-CoV-2 spike protein, the ChAdOx1 nCoV-19 entered clinical trials in Oxford, UK last week. Developed by the Jenner Institute and the Oxford Vaccine Group, at the University of Oxford, trial material has been produced by the Clinical BioManufacturing Facility (CBF) for the Nuffield Department of Medicine and speaking…
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…
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…
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 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 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 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…
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…
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…