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.
Contract research organisation (CRO) ICON has taken a hit to its book-to-bill ratio after Pfizer dropped its anti-cholesterol candidate bococizumab in November.
CMOs will struggle to compete with large in-house capacity investments, according to Results Healthcare which predicts a decline in outsourced biomanufacturing.
Rumours of an Irish expansion freeze have been greatly exaggerated according to Eli Lilly, which says it remains committed to its Kinsale biomanufacturing site.
Amsterdam-based Kiadis Biopharma has received Health Canada approval to initiate a global Phase III trial for an allogenic stem cell therapy for acute leukemia.
Drugmakers have been invited to submit preliminary clinical evidence for cell and gene therapies under the new US FDA Regenerative Advanced Therapy designation
Kite Pharma has formed a joint venture with Shanghai Fosun Pharmaceutical Industrial Development Company to develop and manufacture its cell therapy axicabtagene ciloleucel in the Chinese market.
The development partnership has been extended as GlaxoSmithKline looks to make clinical trial scale batches using Puridify’s Protein A alternative to packed bed chromatography columns.
An automated system co-developed with Cook Regenetec offers a more controlled and repeatable method of thawing cell and gene therapies than traditional techniques, says Asymptote.
WuXi Biologics will make a recombinant soluble LAG-3 protein on behalf of Prima Biomed from its 28,000L single-use facility in China set to open next year.
Plans to build a five-story biomanufacturing plant in Ireland could be shelved following the clinical failure of Pfizer's proposed cholesterol-lowering candidate bococizumab.
Selexis and Xencor have entered into a strategic agreement which strengthens an existing relationship for multi-specific antibody cell line development
Shire says it is closing a plasma fractionating facility in Los Angeles, US but remains positive it can successfully manage its post-Baxalta manufacturing network of 17 sites.
Japan’s early approval process for cell and gene therapies still suffers from clinical recruitment challenges and a solid manufacturing framework, says regenerative medicine group FIRM.
EpimAb Biotherapeutics will combine its bispecific antibody generating technology with Kymab’s mouse mAb production platform in a cross-licensing deal between the two firms.
Lonza and Boehringer-Ingelheim dominate the consolidated biologics CMO space but disposable technologies and improved yields are beginning to change this, says PharmSource’s Jim Miller.
Brexit will not stifle interest in the UK’s cell and gene therapy space, says the CGT Catapult which has reported a tenfold growth in investment since 2012 to £400m ($520m).
GE Healthcare is in discussions with companies looking to buy four fully-equipped ‘off-the-shelf’ facilities as part of a €150m investment into a biomanufacturing campus in Ireland.
Since 2011, Samsung Biologics has built two plants, gained Bristol-Myers Squibb and Roche as clients and launched an IPO. With a third facility under construction, Biopharma-Reporter visited to see the CMO’s ambition in action.
Mammalian cell line developer Selexis has signed a fourth licensing agreement in as many months and is planning a "major expansion" early next year ahead of anticipated demand.
