By Bachem AG
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Bachem bringing innovative tide development and manufacturing technologies to TIDES USA
Bubendorf, Switzerland: –Peptide and Oligonucleotide technology specialist Bachem AG will again be a high profile presence at the prestigious TIDES USA conference in Boston during May, both as a leading partner and also a contributor to the scientific program.
Bachem will exhibit from Booth 423 at the Hynes Convention Center, showcasing its ever-expanding portfolio of CMO capabilities in oligonucleotides, now supplementing its long-established leadership in peptide-based therapies and new chemical entities (NCEs).
MS characterization of synthetic RNA
Bachem’s relationship with the TIDES event extends back to 2008, both as a sponsor and featured contributor. For TIDES USA 2022, Bachem is an event partner, hosting a Spotlight Presentation Luncheon on Day Two of the conference (Tuesday, May 10, from 1130 hrs.). The lunchtime session will feature a presentation from Dr. Giovanni Calderisi, Project Chemist for Quality Control at Bachem Bubendorf in Switzerland responsible for establishing routine workflows for characterization of oligonucleotides and peptides by ultra-high resolution mass spectrometry (MS).
Dr. Calderisi will discuss ‘Novel Approaches In MS Characterization of highly-modified Synthetic RNA’, showing how Bachem has overcome the challenge of characterizing sense strand RNAs with more than 30 nucleotide building blocks and labile modifications such as N-acetylgalactosamine residues. He will explain Bachem’s direct, robust and easy-to-use techniques to fully characterize the nucleotide sequence of highly modified single-stranded RNAs using top down tandem MS, showing how the approach can be applied on single strand level, as well as on siRNA duplex level in a single electrospray ionization MS (ESI-MS) experiment.
Dr. Calderisi will also outline how Bachem has used the MS-based technique to develop an efficient and highly sophisticated LC-MS/MS workflow for the characterization of product-related impurities in oligonucleotides such as methylation, and PS-PO and rC/rU substitution, allowing it to support process development with important structural information.
Peptide CMC Case Study
The following day (Wednesday, May 11, 0930 hrs., Hall B) Bachem will contribute to the scientific track dealing with Peptide Chemistry, Manufacturing and Controls (CMC). Its presentation ‘CMC Development of Peptides: A Case Study’ will focus on recent development and technology transfer of a Peptide API process for Lanreotide as a textbook example of tailoring projects to specific regulatory routes or applications, highlighting the desirability of incorporating risk mitigation approaches suitable for the intended clinical or commercial phase into the CMC strategy for any peptide API.
The presentation will be delivered by Dr. Jyothi Thundimadathil, Associate Director of Technical Operations and CMC Development at Bachem Americas, focusing primarily on NCE pipeline support of peptides and related molecules. Dr. Thundimadathil has more than 20 years of experience in peptide chemistry, and has published more than 40 papers, including book chapters and patents.
Industry 4.0 Tides Manufacturing Concepts
On the final day of TIDES USA, as part of the CMC Strategies for Oligonucleotides and Peptides track (Thursday, May 12, 0900 hrs., Hall B), Bachem’s Head of Oligonucleotides Dr. Daniel Samson will show how Bachem is now incorporating Industry 4.0 concepts into its typical manufacturing processes for ‘Tides-based drug substances. His presentation ‘Implementation of Industry 4.0 Concepts for Manufacturing of Oligonucleotides and Peptides’ will discuss how Bachem’s innovative manufacturing technologies are able to align with the Industry 4.0 (Fourth Industrial Revolution) vision for automation and digitalization of traditional industrial processes through advanced technology and integration to create a ‘smart factory’ in which interconnected and interoperable machines are able to process data autonomously and act with very limited human decision making or intervention.
Dr. Sampson leads Bachem’s oligonucleotide unit including innovation projects, R&D and manufacturing activities. Previously, he was a lab head for process optimization, technology transfer, Quality by Design, and scale-up of synthetic peptide manufacturing procedures and from 2012 was a Vice President API Manufacturing with responsibility for all large-scale solid phase peptide and oligonucleotide syntheses, downstream operations, and CMC activities within Bachem AG.
Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise, Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services.
Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com.
About TIDES USA 2022
The TIDES USA Oligonucleotide and Peptide Therapeutics conference is billed as the pharma industry’s largest event focused on accelerating peptide-based therapeutics to market, featuring leading strategies for expediting R&D and improving CMC efficiency
This annual conference’s scientific agenda includes more than 150 speakers, including the industry’s leading scientists, presenting latest science and industry updates across the entire spectrum from discovery, preclinical, clinical development through CMC, Manufacturing and commercialization of therapeutics and vaccines for oligos, peptides, mRNA and genome editing products.
TIDES USA 2022 will be delivered as a four day hybrid event, with live conference opening May 9 at Boston’s Hynes Convention Center, with a parallel digital event that will be available on demand for two weeks after the main conference closes.
The 2022 conference will feature six parallel discussion tracks on Oligonucleotide CMC, Oligonucleotide Discovery, Peptide CMC, Peptide Discovery, mRNA Therapeutics, and Drug Delivery Innovations.
The event is organized by Informa Connect, with further information at: https://informaconnect.com/tides/.
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