The new $50m facility will house 450 scientists in Rockville, Maryland to work across 12 vaccine development programmes, alongside the non-profit Biopreparedness organisation (BPO).
Newly identified impurities in sugar excipients pose a risk to patients and could explain why some drugs fail safety tests according to scientists from the Netherlands.
While in its early stages, the three-dimensional printing device enclosed in a disposable system could ensure sterile manufacturing of miniaturised organ models or even bioprocessing equipment parts, says Sartorius.
Synthetic biology firm Synpromics will use its PromPT promoter platform to increase stability and reduce the lead time for Sartorius Stedim Cellca’s CHO expression platform.
Arrowhead Pharmaceuticals Inc. has also laid off its Chief scientific officer David Lewis - as part of the 34 staff cull - after several trials using delivery vehicle Ex1 were stopped by the firm.
Eagle Pharmaceuticals Inc. has announced its intention to buy Arsia Therapeutics citing its formulation viscosity reduction platform as the driver for the deal.
The US FDA has cleared Adaptimmune to start a trial of its fat cancer cell therapy, lifting the clinical hold imposed in August when the agency asked for more manufacturing data.
Selexis and Xencor have entered into a strategic agreement which strengthens an existing relationship for multi-specific antibody cell line development
Bespak says the availability of the autoinjector version of UCB’s Cimzia on the UK National Health Service (NHS) is a validation of its delivery technology.
PPD has added 4,300 square feet of new laboratory space for analytical testing of biopharmaceuticals and inhalation devices to the company’s Athlone, Ireland-based GMP facility.
Terms such as ‘copycats’ and ‘knock-offs’ are inaccurate and misleading, say drugmakers. We ask therefore how industry and the media should refer to biosimilar products?
Recipharm has said it will spend SEK5m ($567,000) on a bioanalysis laboratory in Sweden citing the lack of capacity in the Nordic region as a driver for the investment.
Catalent will continue to develop and manufacture a non-Hodgkin’s Lymphoma antibody-drug conjugate (ADC) for Triphase Accelerator Corporation after licensing out the candidate.
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.
Fixed-bed, high cell density bioreactors and a naturally occurring attenuated viral strain will be used by Batavia Biosciences in an attempt to produce an affordable rotavirus vaccine.
Horizon Discovery says flexibility and openness helped the UK’s Centre for Process Innovation (CPI) and Ireland’s NIBRT choose to provide its GS null CHO cell line to the biologics industry.
Lonza has licensed rights to synthetic adeno-associated viral (AAV) vectors developed by scientists at US hearing research centre, Massachusetts Eye and Ear.
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.
Germany's Merck says gene editing can make CHO cells resistant to a tiny mouse virus that continues to be a problem for even animal component-free production processes.
Aluminium adjuvants should not be used in trial placebos according to UK scientists who say the differing physical and biological properties of alum salt forms makes some safer than others.
The International Society for Cellular Therapy (ISCT) has called for a streamlined manufacturing regulatory pathway for cellular therapies to overcome the high upfront costs of manufacturing such products.
A device that isolates and sprays a patient’s own stem cells onto serious burns could have significant implications in the organ regeneration industry, says developer RenovaCare.
Phages, peptides and live biotherapeutics could help combat antibiotic-resistant bacteria but don’t expect heavy R&D investment until people start dying from post-operative infection, says EpiBiome.
Catalent and Zumutor Biologics have combined their technologies to create antibodies with enhanced Antibody Dependent Cellular Cytotoxicity (ADCC) without compromising production levels.
Pfizer pays $150m for Bamboo Therapeutics, and post-merger Shire terminates a Baxalta haemophilia programme. Welcome to Biopharma-Reporter’s gene therapy focus.
Charles River says it is capitalising on the growing number of biologics in development, with its manufacturing business seeing double-digit growth led by demand for biosafety and cell banking services.
Regulatory approvals are driving interest in West's Smartdose and Crystal Zenith delivery technologies, the firm says ahead of the launch of a monthly-dose version of Amgen's Repatha.
Axol Biosceince has teamed up with Metrion Biosciences to provide drug developers with a more accurate means of testing drugs' cardiac safety using stem cells.
