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200 employees will be hired by the end of 2020, with 300 more planning to be hired by 2023.

Subsequent guidance and manufacturing realities make portions of USP Chapters <62 >and <111> significantly less relevant. The authors suggest formal chapter revisions.

Joerg Ahlgrimm has left Lonza and is now leading The Discovery Labs’ mission to establish a powerhouse for cell and gene therapy development and manufacturing in the Philadelphia area.

FDA sent a warning letter to LEC Custom Products for a variety of CGMP violations including use of inappropriate equipment and processes.

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.

FDA issued guidance for applicants that must report annually on the status of postmarketing studies and clinical trials under section 506B of the FD&C Act.

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.

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.

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.

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.

Cytiva will provide the first FlexFactory to be used in the manufacture of pDNA to Akron Bio.

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.”

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.

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.

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.

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.

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.