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Despite a growing number of biosimilar approvals, market uptake remains a challenge.
The authors evaluated the potential of direct filtration for multiple biopharmaceutical candidates. This article is Part 2 of the study.
Proprietary cell lines offer opportunities for achieving high AAV titers.
A tidal wave of questions floats the need for more upstream automation.
Given the criticality of fill/finish processes, it is clear that automation is the next technological step.
March 29, 2024
J&J’s nipocalimab is in development for reducing the risk of FNAIT in alloimmunized pregnant adults, a rare disease that may risk the life of the fetus or newborn.
March 28, 2024
AstraZeneca notes that Ultomiris is the first and only long-acting C5 complement inhibitor that offers NMOSD patients the potential to live without relapsing.
The new Verafit products from STERIS are designed to help manufacturers conform to regulatory requirements laid out in Annex 1.
March 27, 2024
AbbVie’s acquisition of Landos includes a lead asset that boosts its portfolio in autoimmune and inflammatory diseases, while the ADC, ELAHERE, gets full FDA approval.
March 25, 2024
With the Vacaville, Calif., site acquisition, Lonza gains one of the largest biologics manufacturing sites for mammalian cell-based therapeutics.
March 21, 2024
CDMO White Raven aims to reduce contamination risk and gain the capability to handle multiple product formats with the installation of Cytiva’s SA25 Aseptic Filling Workcell.
The health data science division of Optima Partners, bioXcelerate, has released a tool aimed at accelerating the drug discovery process.
March 20, 2024
AstraZeneca’s acquisition of Amolyt Pharma includes eneboparatide, a Phase III therapeutic peptide for the treatment of hypoparathyroidism.
March 19, 2024
Orchard Therapeutics’ Lenmeldy (atidarsagene autotemcel) marks the first gene therapy approved in the US for treating children with metachromatic leukodystrophy.
March 18, 2024
In a non-exclusive licensing agreement, Ricoh will have access to ERS Genomics’ CRISPR/Cas9 genome editing technology to create novel disease models.
March 16, 2024
FDA published the draft guidance to support sponsors in developing treatments for the states of sporadic Alzheimer’s disease.
The digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.