Manufacturing

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.

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.