Partnerships

NanoMab Technology has signed heads of terms with a supplier of Tungsten-188/Rhenium-188 generators, OncoBeta.

The companies have signed a Statement of Intent with Gavi to make 200 million doses of their adjuvanted recombinant protein-based COVID-19 vaccine available for distribution.

Delivery will commence over the course of two months following the EUA and the government will have the ability to purchase up to 650,000 additional vials of the treatment through June 30, 2021 based on product availability and medical need.

The companies will work to provide development strategy consultations, system-building, and clinical trial operations, while lessening development time and reducing risk by centralizing project tasks between companies.

Under the partnership, Catalent has ordered visual inspection machines from Stevanato Group to install at its Bloomington, IN and Anagni, Italy facilities to support customer programs.

Roche will use Dyno’s CapsidMap platform to develop next-generation adeno-associated virus vectors for gene therapies for central nervous system diseases and liver-directed therapies.

The company will supply its LIMS to the Walter Reed Army Institute of Research (WRAIR) to support vaccine production programs for COVID-19 at WRAIR’s pilot bioproduction facility.

The companies are entering into an agreement for the late-stage development and large-scale manufacturing of AZD7442, AstraZeneca’s investigational product for treatment and prevention of COVID-19.

The partnership aims to provide a platform of hiPSC-based assays, drug discovery technologies, high-throughput screening, and high-content screening.

Rentschler will handle the downstream processing to provide highly purified drug substance at its headquarters in Laupheim, Germany.

Through the acquisition, Bristol Myers Squibb will gain access to MyoKardia’s mavacamten, a cardiovascular drug for the treatment of obstructive hypertrophic cardiomyopathy, a chronic heart disease.

The 60,000-ft2 facility was built using CRB’s ONEsolution project delivery method and was designed to expand GRAM’s large-scale fill/finish capacity.

Par Sterile will produce the vaccine for use in Novavax's Phase III clinical trial in the United States, while also providing fill/finish services for commercial distribution in the US.

GRAM is expanding fill/finish capacity and is working with Janssen on tech transfer in preparation for production of Janssen’s SARS-CoV-2 vaccine candidate at GRAM’s Grand Rapids, MI facility.

The companies plan to increase the production output of Ligand’s Captisol for the formulation of Gilead’s COVID-19 treatment Veklury (remdesivir).

Thermo Fisher will handle the technical transfer of the lenzilumab bulk drug substance process, with commercial scale production potentially beginning before the end of 2020.

Samsung will offer large-scale commercial manufacturing for drug substance and drug products to support AstraZeneca’s biologics therapeutics capabilities in the Asia-Pacific region.

Catalent will use T-knife´s TCR platform for a T-cell receptor-based cell therapy at its Gosselies, Belgium, site in order to manufacture clinical batches for European trials in 2021.

BioNTech plans to produce up to 250 million doses of its COVID-19 vaccine candidate, BNT162b2, in the first half of 2021.

Valneva will supply the UK government with an initial 60 million doses of the vaccine in the second half of 2021, if successful, and will provide more doses thereafter.

The funding will help advance the vaccine’s clinical evaluation, potential marketing authorization, development and manufacturing in Germany, and the number of participants in late-stage clinical trials.

Vectura will support the product from Phase I through to commercial launch.

The companies have signed an agreement for the production of two plasmids needed for the manufacture of CG01, a gene therapy for the treatment of drug-resistant focal epilepsy.

Catalent’s Redwood Bioscience subsidiary will develop antibody-drug conjugates (ADCs) for Exelixis using Catalent’s proprietary SMARTag site-specific bioconjugation technology.

AMRI will provide AstraZeneca with manufacturing capacity and sterile fill/finish services at its drug product manufacturing facility in Albuquerque, NM.