A warning letter at manufacturing partner Celltrion could delay approvals of the potential migraine prevention monoclonal antibody fremanezumab and two biosimilar candidates, says Teva.
GigaGen has relocated laboratory and office space in San Francisco to boost development of antibody therapeutics for patients with immune dysregulation.
Novo Nordisk has called on the board of directors at Ablynx to engage in negotiations after the antibody-fragment tech firm rejected its €2.6bn ($3.1bn) acquisition offer.
Teva Pharmaceuticals Australia has selected Berkeley Lights’ biological workflow platform to develop therapeutic antibodies at its R&D site in New South Wales.
GSK will look to optimise its induced pluripotent stem cell (iPSC) differentiation processes through collaboration with high throughput tech firm Plasticell.
OncoQR says its two-part therapeutic vaccines help the immune system to attack cancerous cells more effectively and with fewer side effects than conventional immunotherapies.
Campaigning group People for the Ethical Treatment of Animals (PETA) picketed a conference in Boston on Tuesday to protest the use of animals in drug research and development.
ChromaTan will develop an integrated and continuous downstream purification platform through provisions in the 21st Century Cures Act to support manufacturing initiatives.
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.
Novartis has scaled up manufacturing of wet age-related macular degeneration (AMD) monoclonal antibody RTH258 ahead of a potential regulatory submission next year.
Samsung Biologics wants Big Pharma to up biomanufacturing outsourcing and says lessons learned from the semiconductor industry will give it the advantage in the CMO space.
Shire will consolidate both R&D and biomanufacturing facilities in Massachusetts to establish a rare diseases hub in Cambridge and a ‘Technology Center of Excellence’ in Lexington.
CEO Ken Frazier has told investors investments and partnerships, such as collaboration with messenger RNA firm Moderna Therapeutics, have bolstered Merck & Co.’s vaccine division.
Its new Singapore single-use plant is a fraction of the size of a conventional commercial facility but next-generation biomanufacturing at Amgen points to even smaller, more integrated sites.
Novartis will add around 350 Swiss jobs to support its innovative biologics pipeline as it looks to cut 500 more “traditional” development and manufacturing roles.
A second single-use production line could offer commercial-scale capacity for bispecific antibodies but Glenmark says it would need to scale-up further to support more traditional biologics.
Vaxart says its tablet delivery platform has simplified vaccine production so significantly it may bring manufacturing currently contracted to Lonza back in-house.
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.
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.
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.
Xenetic Biosciences says success for Shire’s haemophilia A candidate SHP656 will validate its PolyXen drug delivery technology platform and could net the firm up to $100m.
Dispatches from the 1st Stem Cell Community Day, Hamburg
Process automation should be incorporated early when developing large scale cell therapy manufacturing platforms, according to a lead scientist from the UK Catapult.
Novartis and Kite Pharma have both submitted autologous leukemia candidates for review, paving the road for the first available chimeric antigen receptor (CAR) T cell therapy.
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.
Hitachi Chemical Co. America will increase its presence in the cell therapy development and manufacturing space through the $75m acquisition of Caladrius Biosciences subsidiary PCT.
'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.
Humacyte has received one of the first US FDA regenerative medicine designations for its investigational human acellular vessels (HAVs) candidate Humacyl.
The investment at the Gödöllö manufacturing site adds 104 jobs and comes a week before GSK breaks ground on a $170m meningitis B vaccine facility in Germany.
Two Bill & Melinda Gates Foundation grants will be used to develop a polio and measles rubella vaccine delivered through microneedles on a sustained-dermal patch.
