Oxford BioMedica saw its share price jump 21% after the US FDA approved Kymriah, the gene modified cell therapy made with the firm’s lentiviral vectors.
CSL Behring will launch itself into the stem cell gene therapy through the acquisition of Calimmune, adding a preclinical candidate and two manufacturing efficiency technologies.
The US FDA has warned a Florida-based clinic and seized vials of a smallpox vaccine in California used to create an unapproved product in a crackdown against "unscrupulous" stem cell firms.
The US FDA has approved its sixth biosimilar and second version of AbbVie’s best-selling monoclonal antibody Humira (adalimumab): Cyltezo, made by Boehringer-Ingelheim.
Industry is feeling the low yield and high cost limitations of the CHO cell line and must look to alternatives to make next-generation biological products, says fungal-based protein expression firm Dyadic International.
Lonza will feed demand for its drug quality testing and formulation capabilities through an expansion at its Drug Product Services site in Basel, Switzerland.
Imraldi becomes the second version of AbbVie’s best-selling biologic Humira (adalimumab) to be approved and the fourth biosimilar success for Samsung Bioepis in Europe.
Oxford Genetics will expand its bioproduction services in the UK and target the US market through an office in Boston after receiving a £7.5m ($9.6m) investment.
Agilent Technologies says it is benefitting from increased antibody and biosimilar R&D and manufacturing, reporting a double-digit growth for its third quarter.
Bioprocessing suppliers have recently expressed optimism in the sector despite a slowdown in growth, and one expert believes this will drive investment in new tech and markets.
A shortage in expertise is causing bottlenecks in the biomanufacturing space with around half of drugmakers struggling to fill processing positions, an industry report finds.
“One of the most productive arrangements in the history of the biotechnology industry” will end, says Regeneron on its monoclonal antibody collaboration with Sanofi.
The EMA has revised its reflection paper on API starting materials to clarify what information drug firms should provide about their starting materials under ICH Q11.
Human tissue-focused products and services firm Reprocell Europe has opened headquarters in Glasgow, Scotland, which it says will boost business and create jobs.
Pfizer has chosen a site in Sanford, North Carolina for a gene therapy production plant, just 40 miles from its recent acquisition Bamboo Therapeutics Inc.
Researchers at US-based North Carolina State University and Duke University have developed a ‘microbot’ which they say could capture and transport single-cells for drug production.
Public Health England has reserved NHS hepatitis B vaccine stocks for people at high risk of infection, citing shortages caused by production interruptions at Merck & Co and GSK.
Kite Pharma has submitted the first CAR-T candidate axicabtagene ciloleucel to the EMA for review and says it is evaluating manufacturing options in Europe.
Filtration drove a record quarter for Repligen which says the addition of Spectrum Pharmaceuticals will further grow its bioprocessing portfolio and geographical presence.
Celltrion Healthcare will purchase more biosimilars from biomanufacturing partner Celltrion Inc. and expand its distribution network after raising one trillion Won ($888m) in an IPO.
Horizon Discovery will allow researchers to modify a genome sequence based on its knock-out CHO K1 cell line in a bid to drive innovation in bioproduction.
Modular facilities and single-use systems are fast becoming a standard part of the bioproduction infrastructure as industry looks to mitigate future capacity constraints.
Seattle Genetics paid Bristol-Myers Squibb $17.8m for the biomanufacturing site and says it will spend a further $25.5m on equipment and improvements to support antibody production.
The US FDA has accepted submission of two further Herceptin (trastuzumab) biosimilars: ABP 980 developed by Amgen and Allergan, and Teva and Celltrion’s CT-P6.
