Formulation and Drug Delivery

Under an expanded agreement with J&J, Catalent Biologics will increase manufacturing capacity at its Anagni, Italy, site to accommodate the large-scale commercial supply of Janssen’s COVID-19 vaccine.

The companies will use capacity at IDT previously reserved for Takeda’s dengue vaccine candidate, TAK-003, to manufacture Janssen Pharmaceutical’s single-shot COVID-19 vaccine.

Lonza will provide a manufacturing suite at its facility in Houston, TX, for the clinical and commercial production of AdCOVID, Altimmune’s single-dose intranasal vaccine candidate.

WuXi will produce SARS-CoV-2 s-proteins for BioVaxys’ COVID-19 vaccine candidate, BVX-0320, and for its Covid-T immunodiagnostic program.

Currently, supporters of the plan include the governments of Germany, Norway, and Ethiopia; Wellcome and the Bill and Melinda Gates Foundation; the World Economic Forum; and WHO, Gavi, and UNICEF.

Rokote Laboratories Finland, an academic spin-out located in Finland, is working to develop a nasal spray vaccine against COVID-19 based on research from the University of Helsinki and the University of Eastern Finland.

USP is collaborating with Phlow to build a new lab that will develop test methods and standards to facilitate broader adoption of continuous manufacturing.

Manufacturing of the vaccine will take place at Baxter’s fill/finish sterile manufacturing facilities located in Bloomington, IN.

The European Medicines Agency has begun a rolling review based on laboratory and clinical studies of the Sputnik V (Gam-COVID-Vac).

The European Medicines Agency and Health Canada have published clinical data used to support the authorization of Moderna’s COVID-19 vaccine.

With funding from the federal government, Merck will expand capacity to produce J&J’s COVID-19 vaccine.

In a pandemic, genetic vaccines offer several advantages over traditional approaches.

Various strategies to improve bioavailability are being continuously evaluated, affording greater commercial prospects for the future.

RDIF has announced that the Sputnik V vaccine for COVID-19 has been approved in Slovakia under the emergency use authorization procedure.

The 3M Polisher ST from 3M Health Care is a single-use anion exchange (AEX) chromatography solution intended to replace the reusable AEX polishing column for biologic drug manufacturing.

FDA moves recommended timeline for API and drug manufacturers to assess impurity risks to March 31, 2021.

Distribution of the first one-dose vaccine for COVID-19 to start in early March.

To prevent future production delays of critical products, the Biden administration is examining supply chain vulnerabilities for pharmaceutical ingredients as part of a longer-range consideration of products important to public health.

The company will join the network of approved manufacturers of the lipid excipients.

New data shows that the COVID-19 vaccines can be stored at standard freezer temperatures for up to two weeks.

Aprecia's compression-free 3DP manufacturing platform and Glatt’s multiparticulate technologies offer solutions to pharmaceutical dosage design challenges.

The agency issued guidance for developers of vaccines, diagnostics, and therapeutics to address variants of the COVID-19 virus.

Once the vaccine has been authorized, Sanofi will provide Johnson & Johnson with access to its vaccine manufacturing plant in Marcy l’Etoile, France, to formulate and fill vials of the vaccine, at a rate of 12 million doses per month.

The companies have expanded their existing partnership to include 40 Million Doses of COVID-19 vaccine for South Korea.

The EC has granted marketing authorization to Celltrion Healthcare for its adalimumab biosimilar, Yuflyma (CT-P17).

The US government will pay $1.95 billion for the additional 100 million doses, bringing the total number of doses supplied by the companies up to 300 million.

Nanoform and Herantis have signed a biologics proof of concept agreement for formulation proof of concept projects aimed at improving nasal drug delivery to the brain.

Lessons learned from the pandemic can advance future biologic drug development and manufacturing.

The agency is developing guidance to help manufacturers make changes to existing COVID-19 vaccines to treat new variants in the coronavirus.

FDA’s Vaccines and Related Biological Products Advisory Committee will meet on Feb. 26, 2021 to discuss the request for emergency use authorization for Janssen Biotech’s COVID-19 vaccine candidate.