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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
A structured assessment process can determine compliance for lifecycle process validation.
Technologies advance security efforts for drug supply chain.
December 06, 2021
Following mixed results from clinical trials, a panel of outside experts voted 13-10 to recommend Merck’s pill for Emergency Use Authorization.
Fully automated enzyme analysis can ease a persistent bottleneck in biocatalyst development for bio/pharmaceutical applications.
December 03, 2021
Subtitle FDA approved rituximab in combination with chemotherapy for pediatric patients with previously untreated, advanced stage, CD20-positive DLBCL/BL/BLL/B-AL.
High price tags threaten to block patient access to potentially life-saving cures and treatments.
December 02, 2021
EMA has fully validated the marketing authorization application for Atara Biotherapeutics’ off-the-shelf allogeneic T-cell therapy, tab-cel (tabelecleucel), with an approval decision expected in 2022.
Timing is everything, and it might be ideal for acceleration of real-time monitoring solutions.
Defining expectations, such as GMPs, is paramount for sourcing the right biopharmaceutical raw materials.
Confounding signals pose challenges to analytical methods necessary for managing residual impurity removal in biotherapeutic manufacturing.
December 01, 2021
While supply chain disruptions have resulted in many alterations to workplace practices, they have also presented an opportunity to get ahead of changes to the EU’s upcoming revision of Annex 1.
Glycosylation monitoring has been heavily dependent on manual processes, but the automation of sample preparation streamlines the overall workflow.