News

The document includes recommendations for the reporting and implementation of changes to container closure system components.

Matthew Lauber, senior director—Cell and Gene Therapy, Consumables & Lab Automation, at Waters Corporation highlights how current technologies are enabling oligonucleotide development.

Matthew Lauber, senior director—Cell and Gene Therapy, Consumables & Lab Automation, at Waters Corporation, considers that status of oligonucleotides on the market.

Matthew Lauber, senior director—Cell and Gene Therapy, Consumables & Lab Automation, at Waters Corporation highlights the company’s motivation behind their new bioanalysis kit for oligonucleotides.

Matthew Lauber, senior director—Cell and Gene Therapy, Consumables & Lab Automation, at Waters Corporation discusses the analytical and downstream purification challenges of oligonucleotides.

Chris Spivey, editorial director for BioPharm International, discusses mRNA advances and the background for the leading scientific conference for the field, with host and co-organizer CureVac CEO Dr. Alexander Zehnder.

The Alliance for mRNA Medicines (AMM) was officially launched at the 11th International mRNA Health Conference in Berlin, Germany.

Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, talks about the differences in designing E&L testing for combination products vs. conventional pharmaceuticals.

Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, discusses the differences in how E&L study design should be approached based on whether the study is following ISO or USP standards.

This is the second biologic approved to treat HS, a painful and reoccurring skin disease.

The EC is calling for interested parties for their safety and orphan drug committees.

According to USP, the products will advance quality and reduce risk in the development and manufacture of biologics and vaccines.

Hollie Barton, senior director, Chromatographic Services, for the PPD clinical research business of Thermo Fisher Scientific, highlights one approach to ensuring the continuation of analytical expertise.

Hollie Barton, senior director, Chromatographic Services, for the PPD clinical research business of Thermo Fisher Scientific, reviews the company’s latest moves in targeting automation.

Hollie Barton, senior director, Chromatographic Services, for the PPD clinical research business of Thermo Fisher Scientific, discusses ways that labs are addressing the pressure of rapid analytical turnaround times.

The new centralized hub will provide advanced testing of nucleic acids, which is expected to simplify mRNA substance testing.

As part of a $30 million investment, Aragen is setting up a new biologics manufacturing facility in Bangalore, India.

Sara Fathollahi, PhD, product application specialist at DFE Pharma, makes the case of how excipient suppliers can support the transition from batch to continuous manufacturing.

Sara Fathollahi, PhD, product application specialist at DFE Pharma, discusses a major challenge in the adoption of continuous manufacturing.

The guidance describes the agency’s procedures for performing remote interactive evaluations at drug manufacturing and bioresearch monitoring facilities.

Sara Fathollahi, PhD, product application specialist at DFE Pharma, points out important redesign concepts critical to adapting continuous manufacturing.

A recent AAPS Salary Survey shows a rising trend in compensation for pharmaceutical scientists since 2022.

CPHI Barcelona has strong showing as bio/pharma industry moves confidently into 2024.

PENBRAYA combines components from two meningococcal vaccines, Trumenba and Nimenrix.

As CMOs continue to invest in cell culture capacity, some are expected to surpass top in-house companies.

Bettersize US showcases their BeNano Series, Bettersizer 2600, and BetterPyc 380 instruments at the AAPS 2023 PharmSci 360 event.

The winners of the 2023 CPHI Pharma Awards were announced on October 25 at the CPHI Barcelona event.

The agency’s solidarity mechanism allows Member States to support each other when there is a shortage of a critical medicines.