A structured assessment process can determine compliance for lifecycle process validation.

Manufacturing Process Robustness

Technologies advance security efforts for drug supply chain.

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Following mixed results from clinical trials, a panel of outside experts voted 13-10 to recommend Merck’s pill for Emergency Use Authorization.

FDA Panel Recommends Merck’s COVID-19 Pill 

Hari Narayanan, PhD, is product marketing manager at Thermo Fisher Scientific.

Fully automated enzyme analysis can ease a persistent bottleneck in biocatalyst development for bio/pharmaceutical applications.

Advancing Enzyme Analysis

Subtitle FDA approved rituximab in combination with chemotherapy for pediatric patients with previously untreated, advanced stage, CD20-positive DLBCL/BL/BLL/B-AL.

Rituximab Plus Chemotherapy Approved by FDA for Select Pediatric Cancers

 Washington Editor, jillwechsler7@gmail.com.

High price tags threaten to block patient access to potentially life-saving cures and treatments.

FDA Grapples with the Promise and Perils of Gene Therapy

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.

Atara Biotherapeutics' MAA for Allogeneic T-cell Immunotherapy Gets EMA Validation

Cynthia A. Challener, PhD, is a contributing editor to BioPharm International.

Timing is everything, and it might be ideal for acceleration of real-time monitoring solutions. 

Process Analytical Technologies for Manufacturing Cell and Gene Therapies

Defining expectations, such as GMPs, is paramount for sourcing the right biopharmaceutical raw materials.

Ensuring Quality When Sourcing Biopharmaceutical Raw Materials 

Feliza Mirasol is the science editor for 

Confounding signals pose challenges to analytical methods necessary for managing residual impurity removal in biotherapeutic manufacturing.

Managing Residual Impurities in Complex Biotherapeutics

Grant Playter is the Assistant Editor for 

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.

Looking Past the Pandemic: The Future of GMPs in Aseptic Processing

Glycosylation monitoring has been heavily dependent on manual processes, but the automation of sample preparation streamlines the overall workflow.

Quality/GMPs

Manufacturing Process Robustness

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