Manufacturing

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.

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

The new site will offer initial design and development, low-volume manufacturing, and scalable high-quality production of wearable drug delivery devices.

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

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

Using a specific addition method to wet the powder bed in twin-screw granulation using a foam binder improves robustness for continuous solid-dosage drug product manufacturing.

RNA is easier to manipulate than DNA but challenging to deliver to the right cells.

Real-time monitoring and the principles of quality by design were used to optimize an OSD coating process.

Cambrex has invested in an expansion of its flexible manufacturing facility in Sweden, which will increase the company’s flexible drug substance manufacturing capacity.

Find connections to suppliers of the materials, equipment, and services you need to develop, manufacture, and distribute crucial therapies, treatments, and vaccines in the 2020 Pharmaceutical Technology Buyers' Guide.

Aji Bio-Pharma launched Ajility, a flexible platform for manufacturing vaccines and therapies.

The site can now support customized product and bioprocess development and custom cell and gene therapy reagent manufacturing.

The expansion included adding new softgel encapsulation lines at its Strathroy, Canada and Sorocaba, Brazil sites for Catalent’s Vegicaps plant-based capsule and its CosmoPod twist-off capsule technologies.

The refurbishment provides enhanced glass melting power, improved glass distribution, and the production of transparent and amber type I glass bottles to meet the increase in demand for glass vials for vaccines and life-saving medicines.

Honeywell Forge Cybersecurity Suite’s improved industrial-grade remote access and added protection and risk monitoring aids remote operations.

The expansions included enhancing high-speed automatic syringe assembly and labeling, vial labeling and cartoning, and auto-injector assembly.

The continuous manufacturing platform can be used for individual unit operations or a complete solid-dosage manufacturing line and can be integrated with third-party equipment.