Manufacturing

The European Medicines Agency recently approved two European Novartis sites in France and Switzerland for the commercial manufacturing of chimeric antigen receptor T-cell cell therapies.

The award will help a bioanalytics startup commercialize instrument technology for pharmaceutical antibody manufacturers.

The company is working to ensure broad global access to its COVID-19 vaccine candidate, following approval from regulators.

Sanofi and GlaxoSmithKline have been selected to supply the US government and the European Union with millions of doses of their COVID-19 vaccine candidate.

The expansion will involve using the facilities’ existing central utilities and labs to supplement its small-scale and large-scale assets.

The therapy, indicated for a rare form of B-cell non-Hodgkin’s lymphoma, was developed by Kite, a Gilead company, which will manufacture the therapy at its facility in El Segundo, CA.

New therapeutics modalities and the need for greater process efficiency are driving technology development.

Process modeling offers an opportunity to troubleshoot for and anticipate difficult aspects of a bioprocess.

It is critical to evaluate specific considerations, from design to application, for the benefit of downstream bioprocessing and manufacturing.

Filling and packaging of primary containers is a crucial piece of COVID-19 vaccine production.

Technologies in use and on the horizon could change aseptic processing in ways that seemed inconceivable years ago but approaches to aseptic process validation still need to move beyond their 1970s roots.

Efforts are already underway to harmonize standards and regulatory approaches for testing of raw and ancillary materials, but continuous improvement is required.

Glycoengineering is growing in importance as a technique to improve antibody therapeutic efficacy, safety, and product quality.

Fujifilm Diosynth Biotechnologies’ North Carolina site will be used to manufacture Novavax’ NVX‑CoV2373 vaccine candidate for a Phase III clinical trial.

GSK and CureVac will collaborate on mRNA-based vaccines and mAbs. Separately, the EIB and others provided CureVac with financing for development of its CVnCoV vaccine candidate and expansion of manufacturing.

GSK and CureVac will collaborate on mRNA-based vaccines and mAbs. Separately, the EIB and others provided CureVac with financing for development of its CVnCoV vaccine candidate and expansion of manufacturing.

The agreement will accelerate production of SiO2’s plastic vials for vaccines and therapeutics for Operation Warp Speed.

Stevanato Group’s Vision Robot Unit uses AI-based machine learning capabilities for particle and cosmetic inspection of biopharmaceutical drug products.

BARDA and DOD have awarded a $450-million contract to Regeneron Pharmaceuticals to manufacture and supply an investigational double antibody cocktail in development for treating COVID-19.

The acquisition will give the CDMO additional clinical filling options in Europe, which is expected to come online in 2021.

The new facility in Grand Rapids, MI, is part of the CDMO’s aggressive expansion plan.

Innovative approaches, including ready-to-use materials and in-line dilution, can significantly streamline overall bioprocessing operations.

Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach.

Manufacturers must address scale-out challenges of autologous cell therapy for commercial manufacturing.

The ISPE FOYA 2020 category awards included biologics facilities.