Pharmaceutical Technology Editors

The 6th-generation Eclipse FFF system handles analytes such as proteins, polymers, viruses, gene vectors, and liposomal drug nanoparticles.

The companies will work to accelerate the clinical development and manufacturing of the treatment, while determining its safety and efficacy.

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

The name change touches on the company’s AI and machine learning proficiencies, while including the expansion of the company’s mission to serve additional regulated industries including animal health, cosmetics, medical devices, specialty chemicals, nutraceuticals, and food and beverage.

Vetter has moved into new headquarters located in Ravensburg, Germany, and plans to continue its long-term investment for corporate development.

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.

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.

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.

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.

The lab, which is currently available to customers, can handle highly potent compounds.

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 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.

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.”

The approval comes after a Phase III trial that showed Keytruda reduced the risk of disease progression or death by 35%.

Shimadzu, has opened a new branch office in Copenhagen, Denmark.

Cambrex has completed the expansion of its solid form screening and crystallization process development facility in Edinburgh, Scotland.

Oxular has been granted rare pediatric disease and orphan drug designations by the US FDA for its proprietary drug, OXU-003.

The UK's MHRA has joined the Australia-Canada-Singapore-Switzerland (ACSS) Consortium of regulators.

Recent data, from BIA and Clarivate, has revealed that investment in UK biotech continues to be strong.

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.

The winners were announced during day seven of CPhI Festival of Pharma.

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.

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 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.