This fall TIDES USA returned to Boston for a live, in-person event, aimed to bring attendees strategies to accelerate their therapeutics from laboratory to market. TIDES Europe was live in Brussels, Belgium in November 2021. The presentations shared leading strategies for expediting research and development and improving chemistry, manufacturing, and control (CMC) efficiencies.
In this ebook, we look at not only how to improve process efficiencies and overcome challenges in process development and scale-up, CMC and manufacturing, but also take a look at regulatory expectations, new technologies and alternative approaches for emerging complex molecules. This includes a look at mRNA therapeutics and vaccines from industry-leading companies.
The next pages include presentation overviews from the recent TIDES events, with insights from Asahi Kasei Bioprocess, BfArM (The Federal Institute for Drugs and Medical Devices, Germany), GSK, Editas Medicine, BioNTech and more.
1. CMC Regulatory Considerations for Oligonucleotides and Peptides: Similarities and Differences
Dr. Rene Thurmer, Deputy Head of BfArM in Germany discussed the presence of impurities and importance of starting materials and what documentation is needed in IND applications.
2. Effectively Scaling up the Oligonucleotide Manufacturing Process
Asahi Kasei Bioprocess America’s Scott Merz explains how to effectively scale up the Oligonucleotide Manufacturing Process.
3. Refractive Index: The Ultimate Tool for Real-Time Monitoring of Solid-Phase Peptide Synthesis
Dr. Beatriz G. de la Torre, Research Professor from the Laboratory of Medicine at the University of KwaZulu-Natal presented a promising method for monitoring solid-phase peptide synthesis (SPPS) using UV absorption measurement.
4. Development of Complementary LC/UV and LC/MS Methods for Quantifying ASO-Related Organic Impurities
Chris Gripton, Principal Scientist at GSK shares methods for anti-sense oligonucleotide impurity detection.
5. CMC Perspectives on mRNA Therapeutics
Julia Schlereth from BioNTech gave an overview of CMC issues, specifically RNA integrity, in mRNA vaccine manufacture.
Jump to any article using the contents on the following page, or at any time using the Contents menu in the top left. There you can also download this eBook as a PDF.
6. mRNA Development and Manufacturing
Dr. Ulrich Blaschke, Vice President of Technical Development at BioNTech AG shares insights from Project Light Speed, the United States government's initiative to streamline a COVID-19 vaccine, and how the industry may benefit from the initiative in the future.
7. IND-Enabling Small-Scale Guide RNA Production Under GMP for CRISPR-Based Cell Therapies
Keith Jarvis, Senior Director of Process Chemistry at Editas Medicine discusses ex vivo CRISPR-based cell therapy production including analytical testing for product release.
