The Netherlands and India have signed a MOU (Memorandum of Understanding) under which a government-based institute of the Netherlands will extend technical support for the development and manufacturing of the measles-rubella vaccine.
Novartis has partnered with Google-backed Rani Therapeutics to assess an oral platform which delivers biologics through the intestinal wall using needles made of sugar.
Alexion will expand its manufacturing network with a €450m ($507m) biologics facility in Ireland, a week after entering an $8.4bn agreement to acquire Synageva.
AstraZeneca has inked a development and commercialisation deal with Celgene for its haematology programmed cell death ligand 1 (PD-L1) candidate, MEDI4736.
A new round of €8.4m ($8.9m) in grants will help develop a scalable manufacturing process to wean vaccines off of their cold-chain dependency and help ensure they can be manufactured as stable and temperature independent.
Sartorius has launched a cell harvesting technology, the first to incorporate diatomaceous earth filtration more commonly associated with the brewing industry.
Ensuring drugs, APIs and excipients are safe will be a focus for the EMA, which says it will explore supplier inspection databases and using trade deals like TTIP to promote GMP standards globally.
Biosimilar firms seeking US approval will not have to commit to share manufacturing data with reference drug firms before reviews, after the FDA rejected Amgen’s request for such a rule.
US desire for an alternative to the current multi-shot anthrax vaccine is a boon for delivery systems firm Glide Technologies, which had its contract extended by Pfenex this week.
Repligen has finished an expansion at its US filtration system facility eight months after bolstering its offering in this area by buying a platform from Refine Technology.
US government scientists told a House subcommittee on oversight and investigations on Tuesday that the six months production time necessary for flu vaccine manufacturers can create difficulties for health experts selecting the appropriate virus strains...
Researchers have used shear stress to repair misfolded proteins in an approach that could help biopharmaceutical firms bypass expensive refolding techniques and time-consuming cell line optimization.
Turkey’s efforts to increase local biopharmaceutical production have prompted GE Healthcare Life Sciences to set up a biopharmaceutical technology training centre in Istanbul.
The petition with the US FDA signals Amgen’s anger over Sandoz’s failure to disclose certain information from its biosimilar application, including how the biosimilar is manufactured.
GSK is keeping its Ebola vaccine production in-house, despite previously leaked documents which suggested the company could not ramp up volume of BS-2 manufacturing without impacting its other vaccine lines.
Emergent BioSolutions has initiated a non-clinical study to demonstrate it can scale-up production of its anthrax vaccine, BioThrax, without making it less effective.
Ampio Biopharmaceuticals will delay the release of Ampion trial data after discovering the drug was damaged by temperature fluctuations during shipment.
Second quarter sales of cryopreservation media grew 14% but BioLife Solutions says it expects revenues to skyrocket as clients’ biologics move out of the clinical stage..
Formulations that stop biopharmaceuticals being degraded by vials and syringes could help biopharmas avoid recalls and improve product shelf life says the UK team behind an industry focused research collaboration.
As part of an effort to meet a rising demand for biopharmaceuticals, Germany-based Merck has agreed to invest about $68m (€50m) in its Italian production site in Bari.
The UK manufacturing sector covers all of its bases in terms of the current cell therapy manufacturing requirements and includes “a strong manufacturing base” to bring early phase academic research into the clinic, according to a survey conducted by Cell...
Biopharma is ramping up the outsourcing of some of the easier tests while tasks such as downstream process development and QbD services are being outsourced less, according to a new survey.
Thermo Fisher has launched a pump technology designed for applications across the bioprocessing production line and usable with "all" bioprocessing tech.
Adaptimmune has selected Biolife’s cryopreservation media for its genetically modified T-cell receptor (TCR) product citing its ability to retain viability and potency.
Janssen has asked Novozymes Biopharma to help it reduce drug dosage “from daily to every two weeks or monthly” using its half-life extension technology.
When Frank Sinatra sang "If you can make it there, you can make it anywhere" in New York, New York he probably wasn't talking about biopharmaceutical production.
The US FDA says that it “becomes concerned” when excess volume in an injectable vial is greater or less than what the US Pharmacopeia (USP) recommends without proper justification, according to new draft guidance.
Patheon brings fill/finish capabilities to DSM’s biomanufacturing services, President of Biopharma at the recently merged company DPx told Biopharma-Reporter.com in an exclusive interview.
Bayer is investing over €500m ($700m) in manufacturing recombinant factor VIII (rFVIII) products citing growing demand for long-term prophylactic treatment rather than ‘on-demand’ haemophilia drugs.
Cobra Biologics is looking for more scientists with plasmid production skills after BioCancell became the fifth firm in a year to ask the CMO to manufacture a DNA-based gene therapy candidate.
The US FDA has issued draft guidance to help the biopharmaceutical industry assemble information and present data to support its analytical methodologies.
The US Food and Drug Administration (FDA) has issued Amgen with a Warning Letter at its Thousand Oaks, California plant citing violations in the production of monoclonal antibody combination products.
Shipments of chicken pox vaccines from a troubled Belgian facility should recommence in early Q2 2014, says GSK, though the root cause of the manufacturing issues are still unknown.
