Manufacturing

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

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.

Negotiations for a final advance purchase agreement where the Government of Canada purchases the vaccine candidate on a not-for-profit basis for emergency pandemic use are underway.

The vaccine will be supplied by Moderna and distributed in Japan by Takeda Pharmaceutical starting in the first half of 2021 if the vaccine candidate receives regulatory approval.

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

Novavax and the Government of Canada will finalize an advanced purchase agreement under which Novavax will supply doses of NVX-CoV2373 to Canada beginning in the second quarter of 2021.

Oxford Biomedica will reserve capacity for AstraZeneca in three of its manufacturing suites in its new commercial manufacturing center, Oxbox, for 18 months.

The new facility, located in Lenexa, KS, will rapidly expand production of viral transport media.

How real estate can accelerate productivity as life sciences companies prioritize COVID-19 therapeutics, vaccines, and new diagnostics R&D amidst new guidelines.

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.

The contract is valued at $106.3 million and is supported by Operation Warp Speed.

Medical management services provider, Europital, has announced the opening of a new site in Oxford, United Kingdom, in response to demand from small and medium innovators within the biotech industry.

The European Commission (EC) and Moderna have concluded exploratory talks on the potential purchase of Moderna’s COVID-19 vaccine candidate for Europeans.

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

The Phase II trial is a randomized, placebo-controlled, observer-blinded study that will include patients aged 18 to 84 years.

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.

SK bioscience will manufacture the vaccine antigen component for use in the final drug product at its vaccine facility in Andong L-house, South Korea.

In combination with BARDA’s previous award, the commitment for early access to Moderna’s vaccine candidate has now reached to up to $2.48 billion.

The companies will collaborate on the manufacturing, clinical development, and regulatory activities for Novavax’s COVID-19 vaccine in Japan.

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.