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September 09, 2020
The new facility will be adjacent to Thermo Fisher’s newly expanded biologics manufacturing facility.
Catalent’s Redwood Bioscience subsidiary will develop antibody-drug conjugates (ADCs) for Exelixis using Catalent’s proprietary SMARTag site-specific bioconjugation technology.
The new line has the ability to aseptically fill powder, liquid, suspension, and combination forms into vials in clinical or commercial batch sizes.
The Faciliflex Express product line can be commissioned in six months, making it ideal for cell and gene therapy companies that need to rapidly bring their therapies to patients.
AMRI will provide AstraZeneca with manufacturing capacity and sterile fill/finish services at its drug product manufacturing facility in Albuquerque, NM.
September 08, 2020
The clinical trials of the AstraZeneca Oxford COVID-19 vaccine, AZD1222, have been paused for a safety review as a result of an incident of an unexplained illness in a UK trial patient.
As public confidence in the drug development process waivers, leading vaccine developers promise to adhere to scientific and regulatory principles.
Industry leaders insist they will maintain high standards for clinical trials and regulatory submissions for new vaccines and therapeutics to combat COVID-19.
September 03, 2020
The companies have signed a partnership agreement to provide extractables and leachables testing at the SG US Technology Excellence Center in Boston, MA.
The new line will add capacity to Catalent’s pipeline of clinical programs and commercial launches at the site.