Vaxart says its tablet delivery platform has simplified vaccine production so significantly it may bring manufacturing currently contracted to Lonza back in-house.
An inconsistent lot of excipient Poloxamer 188 cut biologic yield 30%, but working with supplier BASF was key to prevent future problems, according to Roche.
The Chinese hamster ovary (CHO) cell line is not the future for biomanufacturing says Biogen, which will publish results from a study of alternative hosts later this year.
Sanofi Pasteur says heavy investment in messenger RNA (mRNA) is warranted as such technology could revolutionise vaccine development and manufacturing.
Samsung Bioepis’ Renflexis has become the second biosimilar of rheumatoid arthritis biologic Remicade (infliximab) to be recommended for approval in the US.
European biotech companies Valneva and Bavarian Nordic have entered a commercial agreement to develop cell-based vaccines using production methods that are faster and cheaper than methods that use hen’s eggs.
Scottish synthetic biology firm Synpromics has received £5.2M ($6.6M) to enhance its synthetic promoter design technology used in gene therapy development.
Manufacturing tweaks have severe effects on the quality and yield of stem cells, says Pluristem which has successfully scaled-up production through a decade of process development evolution.
Abeona Therapeutics says it plans to file its single injection adeno-associated virus (AAV) gene therapy for Sanfilippo syndrome in the US in late 2018.
GE Healthcare has agreed to help Cellular Biomedicine Group (CBMG) develop CAR-T and stem cell production technologies to support its aim of making 10,000 cancer cell therapies a year.
Sumitomo Dainippon Pharma Co Ltd has ordered cell culture technologies from Hitachi as part of its effort to develop a treatment for Parkinson’s disease.
Medcision has started pushing its cell therapy thawing technology through an early adopter scheme designed to encourage adoption by firms with candidates in trials.
The only practical way to scale-up volumes of mesenchymal stem cells (MSCs) is by using microcarriers in single-use bioreactors, say scientists from A*STAR and Instituto Superior Técnico.
Morphotek Inc has launched an antibody-drug conjugate (ADC) services business incorporating its RESPECT site-specific conjugation technology and eribulin-linker toxin platform.
Lonza's biopharma business grew faster than other divisions in 2016 with a drug firm becoming the Swiss life science supplier's biggest customer for the first time since 2013
Plasticell has partnered with Singapore’s Agency for Science, Technology and Research (A*STAR) and the Nanyang Technological University (NTU) to advance its stem cell pipeline.
A two-step manufacturing process makes antibody-drug conjugate production expensive and causes stability issues, says Eleven Biotherapeutics which is fusing antibody fragments to cytotoxic proteins.
'One-litre bioreactor scale currently the maximal for stem cell expansion and differentiation'
Stem cell therapy developers are lacking production scale-up technologies, says the chair of an upcoming conference bringing industry and academia together to address the problem.
The European Commission has rejected PIC/S criticism of a plan to develop GMP for advanced therapies and stressed that separate rules will not mean a lowering of standards.
Separate GMP rules for advanced therapies would put patients at risk according to the PIC/S, which has called on the European Commission (EC) to rethink the idea.
Roquette says investments in packaging, documentation and testing requirements have helped the firm move into the biologics excipient and reagent space.
Assuring anaerobic conditions in a fermenter design for aerobic organisms will be key in making Ondek’s Helicobacter pylori-based immunotherapy, says 3P Biopharmaceuticals.
Canada-based Tonix Pharmaceuticals has developed a novel live-virus vaccine for smallpox, which the firm claims is a safer alternative for biodefense stockpiles.
Russia’s Ministry of Health has awarded Biocad marketing authorisation for a biosimilar version of EMD Serono’s Multiple sclerosis drug Rebif (interferon beta-1a).
Sartorius’ third acquisition in the bioanalysis space in the past year will add Essen BioScience’s real-time live-cell analysis platform to its portfolio.
Lot-to-lot consistency is key for fetal bovine serum (FBS) supply, says Nucleus Biologics which is offering clients stable volumes and prices on its single-sourced serum.
Cell therapy developers can source “regulator ready” stem cells from the UK Stem Cell Bank (UKSCB) for a £500 per vial fee under a scheme announced by the MHRA.
Sanofi and Lonza will construct a large-scale mammalian cell culture manufacturing site in Switzerland, with an initial investment of CHF 290m ($288m).
CellGenix GmbH has started expanding its cell and gene therapy reagents facility in Freiburg, Germany citing the progression of customer projects into clinical development and commercial launch.
BriaCell Therapeutics Corp. has submitted a chemistry, manufacturing and control (CMC) amendment to the US FDA before its planned stem-cell based vaccine trial for late stage breast cancer.
GE Healthcare has teamed up with the Austrian Centre of Industrial Biotechnology (acib) in an effort to remove trial and error from the cell line optimization process.
If reinstated, Donald Trump’s order restricting travel to the US would hurt the cell therapy sector according to the International Society for Cellular Therapy (ISCT).
The Novo Nordisk Foundation has awarded a DKK118m ($17m) grant to fund development of a fermentation pilot plant for cell line scale up experiments at the Technical University of Denmark.
GE Healthcare says a new inflatable bioreactor bag configured in perfusion mode can achieve a cell density over four times that of the current industry standard.
Shark antibodies are an attractive way to deliver biologics to the brain, says Ossianix which is using its blood-brain barrier (BBB) crossing technology in collaboration with Lundbeck.
Merck has announced plans for process and cell line development centres in the US and China citing biopharmaceutical industry demand for integrated services.
Absorption Systems has announced a technology licensing agreement with Pfizer Inc., in which the pharma company will use the preclinical CRO’s cell lines to test potential drug candidates.
GE Healthcare hopes to increase the yield of biopharmaceuticals made using its Chinese Hamster Ovary (CHO) expression system through a partnership with synthetic biology firm Synpromics.
