Manufacturing

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

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

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 companies have agreements to supply its mRNA-based COVID-19 vaccine to Japan and Canada, pending regulatory approvals in those countries.

The expanded facility will feature two new 40-L and 300-L manufacturing vessels, a capsule filling line, and six drying tunnels that will add more than 10 million doses per annum to the site.

The new facility will give the company’s Australian customers access to tablet formulation and coating services in order to shorten supply chains and increase the region’s pharmaceutical sector capacity.

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.

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

Healthcare groups met in late July 2020 to discuss the state of the US pharmaceutical supply chain and the impact of COVID-19.

This article presents the results of a survey conducted to gain insight on the impact of the COVID-19 pandemic on biomanufacturing operations.

The investment will allow for the expansion of analytical R&D efforts and will support the company’s reference materials business.

Pharmaceutical Technology spoke with Matthew Woodcock, director of LLamasoft, a supply chain analytics company that assists companies in their decision-making and supply chain challenges, about the impact the COVID-19 pandemic has had on the pharmaceutical supply chain.

Understanding and overcoming excipient variation are crucial for successful continuous processes.

Even though many companies are at early stages of digital automation, more are evaluating BioPharma 4.0 tools and leveraging built-in automation to speed scale-up and boost efficiency.

Regulatory, analytical, and process concerns must be taken into account.

COVID-19 has brought to light the issues of European manufacturing capabilities, leading industry to question whether it is now time to reinvest in domestic medicines supply.

The early success seen on the market for approved cell and gene therapies poses both technical and manufacturing challenges for pipeline candidates on the road to commercialization.

Outsourcing partners provide capacity and tech transfer expertise in the pharmaceutical industry response to the COVID-19 pandemic.

For pharmaceutical manufacturers and their contract partners, blockchain and the Internet of Things promise to enable return on investment, not only by preventing counterfeiting and verifying returns but by enabling real-time condition monitoring and automating supply contracts.

CMOs and CDMOs expanded their services and facilities in 2020.

The companies will utilize Avid’s upstream and downstream process development and drug substance manufacturing services in conjunction with Argonaut’s parenteral drug product fill-finish services for the delivery of CGMP parenteral drug products for use in clinical studies.

The UK government is committing a further £100 million (US $127 million) to ensure that there is capability to manufacture a successful COVID-19 vaccine at scale in the UK.

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.

Data and software identify optimum pharmaceutical packaging choices for the required shelf-life.

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

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.

CordenPharma added a 3000-L solid-phase peptide synthesis vessel to its GMP API facility in Boulder, CO.

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.