Manufacturing

For certain APIs, including semi-synthetic antibiotics, continuous filtration and drying improves productivity and quality.

Increased use of nested and ready-to-use primary packaging has resulted in a need for more validation data on container-closure integrity. This article describes efforts to develop these data for new and traditional containers and closures.

The facility offers office, production, sampling, and warehouse space and delivers products to all major global markets.

The collaboration includes an integrated program that encompasses formulation development, drug substances, and drug product manufacturing.

In the study, GigaGen presents a novel technology for producing a new class of drug, recombinant hyperimmunes, that may potentially generate new COVID-19 therapies.

Catalent will manufacture drug substance for AZD1222 at its Harmans, MD facility.

CDMO Avid Bioservices will provide development and drug substance manufacturing for Oragenics’ novel COVID-19 vaccine candidate, Terra CoV-2.

CARBOGEN AMCIS has announced significant investments to increase manufacturing capacity in Switzerland and France.

The collaboration will increase the supply of the potential treatment to at least three and a half times the current capacity.

Plastic primary packaging could help prevent supply chain shortages associated with high demand for COVID-19 vaccines.

Early adopters and equipment manufacturers refine their equipment and processes, paving the way for broader use.

The Optima FPA assembles pen injectors either fully or semi-automatically.

Experts at Hovione describe progress being made in understanding how to optimize continuous processes for oral solid-dosage drug products.

The company has made several moves in recent weeks to expand manufacturing capacity and cell line services.

The CDMO will offer capacity for manufacturing and distributing COVID-19 vaccines and therapeutics at its Grand Rapids, MI, fill/finish facility.

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 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 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.

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.

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.

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.