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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.

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

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

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.

Pharmaceutical Technology Europe® spoke with Ole Wiborg from Zerion Pharma, a Danish pharmaceutical development company, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

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.

Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, recommends some key issues that pharma manufacturers should consider when formulating products that require a medical device.

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.

Pharmaceutical Technology Europe® spoke with Gustavo Ferrer from Dr. Ferrer BioPharma, a US company focused on innovative intranasal medications, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

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

Pharmaceutical Technology Europe® spoke with Leonardo Vincenzi from CONTINUUS Pharmaceuticals, a US company that specializes in process development, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

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.

Pharmaceutical Technology Europe® spoke with Joren van der Horst from Luo Automation, a Dutch company focused on automated visual inspection solutions, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

Pharmaceutical Technology Europe® spoke with Carlos Rial Calvo from FABRX, a pharmaceutical 3D printing company, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

Pharmaceutical Technology Europe® spoke with Dr. Tom Kamperman from IamFluidics, a Dutch high-tech company that develops customized microencapsulation solutions, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

Pharmaceutical Technology Europe® spoke with Gautam Shetty from Congruence Medical Solutions, a US drug delivery device company, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

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.

Pharmaceutical Technology Europe® spoke with Dr. Rainer Schmidt from Galvita AG, an excipient manufacturer based in Switzerland, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

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