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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 01, 2024
The partnership will allow for both companies to provide end-to-end biopharmaceutical manufacturing solutions.
CordenPharma’s new starter kits are designed to enable effective formulation in the development of mRNA-based therapeutics.
While Catalent’s acquisition is definitely about making drugs, it’s also very much about making money.
The license holder should negotiate, educate, contract, and then oversee the transportation contractor, says Siegfried Schmitt, vice president, Technical at Parexel.
February 28, 2024
The company is investing more than $250 million into its Bloomington, Ind. Manufacturing site.
Nona Biosciences and Boostimmune will collaborate to develop ADCs against novel targets using Nona’s proprietary platform technology.
Steffen Thirstrup, chief medical officer, EMA, emphasizes the importance of transparency in investigating potential safety issues of CAR-T therapies, while highlighting the need to balance regulatory diligence with maintaining trust within the community and among stakeholders.
February 27, 2024
CSL will share access to Cytegrity, its proprietary stable production system for lentiviral vector production, with Genezen.
The agency has recommended granting marketing authorization to ALS treatment, Qalsody (tofersen), for adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.
February 23, 2024
Steffen Thirstrup, chief medical officer of the EMA, discusses manufacturing supply, drug shortages, commercial incentives, politics, and patient wellbeing.
February 22, 2024
Daiichi Sankyo is investing approximately €1 billiion (US$1.08 billion) to expand its Pfaffenhofen an der Ilm, Germany, site for ADC development and production.
February 21, 2024
FDA's Drug Safety Priorities FY23 describes the center’s key safety programs and activities involved in promoting and protecting public health.