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© 2020 MJH Life Sciences and BioPharm International. All rights reserved.
© 2020 MJH Life Sciences™ and BioPharm International. All rights reserved.
FDA releases vaccine EUA guidance; distribution presents challenges
October 20, 2020
Orgenesis has completed its previously announced acquisition of Koligo Therapeutics with the additional acquisition of Tissue Genesis’ cell isolation technology, Icellator.
The company’s new closed cell therapy processing system enables scalable, cost-effective development and manufacturing of cell therapies.
OptiGel DR softgel capsules are formed by the combination of pectin, a naturally derived polysaccharide, and gelatin, which eliminates the need for a separate capsule coating step.
The company was selected because of its nucleic acid platform which, when combined with virotherapy, has the potential to treat liver cancer by using a lipid nanoparticle delivery system.
Rigaku is featuring its latest x-ray instrumentation at three virtual booths at the virtual 27th International Trade Fair for Laboratory Technology, Analysis, and Biotechnology conference.
Branching out from roots in industrial biotechnology, Riffyn Data Systems (and its CEO Tim Gardner) is taking the message of data-driven process improvement to biopharma.
October 19, 2020
The facility will include a high-speed sterile line for live virus filling, a line for standard fill/finish, cleanroom capacity, labs, warehousing, and offices to support production.
The much-anticipated meeting of FDA’s vaccine advisory committee this week is slated to address a number of critical issues related to testing and approval of vaccines to prevent COVID-19 infection.
October 16, 2020
The new VirusExpress lentiviral production platform increases dose yields and reduces process development time for cell and gene therapies.
The new facility at the company’s San Diego, CA, site will be for late phase and commercial CGMP manufacturing.
October 15, 2020
Recent data, from BIA and Clarivate, has revealed that investment in UK biotech continues to be strong.
The UK's MHRA has joined the Australia-Canada-Singapore-Switzerland (ACSS) Consortium of regulators.
AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.
Cytiva will provide the first FlexFactory to be used in the manufacture of pDNA to Akron Bio.
Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.
The approval comes after a Phase III trial that showed Keytruda reduced the risk of disease progression or death by 35%.
Regeneron will distribute Inmazeb treatment doses over the course of six years to BARDA.
The judges chose Sheng from a shortlist of seven candidates and highlighted his work in the Taiwanese and global markets while guiding the company through “pivotal changes” that demonstrated his abilities as a “top CEO.”
Ongoing and emerging cyber-risks to legacy operational technology systems in bio/pharmaceutical manufacturing must be addressed.
Analysts should understand how a monograph, together with the associated general notices and general chapters, relate to their responsibilities under good manufacturing practices.
October 14, 2020
Roche will use Dyno’s CapsidMap platform to develop next-generation adeno-associated virus vectors for gene therapies for central nervous system diseases and liver-directed therapies.
October 13, 2020
Virtual Touring allows companies to inspect and visit vendor and contract partner sites remotely during the COVID-19 pandemic.
The unexplained illness in a study participant is being reviewed and evaluated by an independent data safety monitoring board and internal clinical and safety physicians.
The company will supply its LIMS to the Walter Reed Army Institute of Research (WRAIR) to support vaccine production programs for COVID-19 at WRAIR’s pilot bioproduction facility.
October 12, 2020
The companies are entering into an agreement for the late-stage development and large-scale manufacturing of AZD7442, AstraZeneca’s investigational product for treatment and prevention of COVID-19.
October 09, 2020
The partnership aims to provide a platform of hiPSC-based assays, drug discovery technologies, high-throughput screening, and high-content screening.
Rentschler will handle the downstream processing to provide highly purified drug substance at its headquarters in Laupheim, Germany.
October 08, 2020
Independent research performed at the University of St. Andrews in the UK has reportedly demonstrated the effectiveness of Alfacyte in-vitro against SARS-CoV-2.
Under the contract, Pharm-Olam will offer routine and response clinical services for the development of medical countermeasures.
October 07, 2020
The guidance provides recommendations for data and information needed to support an EUA for COVID-19 vaccines.