TIDES USA

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about the Event

Bachem is an event partner at the Industry’s largest & most renowned event to accelerate your therapeutics to market: leading strategies for expediting R&D and improving CMC efficiency.  

Unparalleled access to new data & case studies from globally recognized speakers across the entire landscape of oligonucleotides, peptides, mRNA, genome editing, drug delivery, and partnerships – from discovery to market.
 
Come visit our booth #681 and have an ice cream while speaking with our experts on Wednesday and Thursday.
 

Preconference Workshop Presentation

Speaker

Gerhard Haas, PhD, Vice President, Quality Assurance and Regulatory Affairs at Bachem AG

Gerhard joined Bachem in 1992 after having completed his doctorate in organic chemistry at the University of Stuttgart in Germany. Having held various roles at Bachem including R&D, Production, QC, QA, and RA he is a seasoned expert of all areas related to synthetic peptides.

Abstract

Experience with the FDA Guidance ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin

When the FDA Guidance was published, many public comments from industry expressed concerns regarding the feasibility to comply with the guidance expectations. In the meantime, experience has been obtained with some of the peptides covered by the guidance. This presentation will reiterate the guidance requirements together with Bachem’s respective experience obtained so far.

September 20, 3:15pm

Preconference Workshop Presentation

Speaker

Ralf Eisenhuth, PhD, Process Manager Technology Transfer and Chromatography at Bachem AG

Dr. Ralf Eisenhuth spent the last decade at Bachem in positions ranging from small scale development to director of the large scale API purification department. In his current position as Process Manager Chromatography and Technology Transfer, his main focus is cutting edge technologies and automation of existing manufacturing processes.

Abstract

Purification of Synthetic Oligonucleotides: A CMO Perspective

Purification of synthetic oligonucleotides is a very material intensive process, consuming huge amounts of solvent per kg of drug substance. Different purification strategies and their impact on the PMI of the manufacturing process and the applications of MCSGP for process intensification and solvent reduction will be discussed.

September 20, 3:30pm

Main Conference Presentation

Speaker

Joseph Fraone, Business Development Manager, Oligonucleotides

Joe joined Bachem Americas business development team in June of 2020.  With a primary focus on Bachem’s Oligonucleotide API manufacturing business, he brings 13 years of direct experience in the synthesis, purification, modification, and analysis of oligonucleotides in both research and GMP settings.  In 2021, Joe made the move from the bench to customer-facing roles and sales by building and leading the scientific applications group for novel technology and engineering firm, CryoXtract Instruments, and leading the business development activities for an aptamer discovery CRO, Base Pair Biotechnologies.

Abstract

Turning Tides Together. Manufacturing of Peptides and Oligonucleotides

Bachem known as the leading CMO for pharmaceutical grade peptides is expanding its technology platform to offer chemical manufacturing services for nucleic acid based APIs. We would like to take the opportunity to present Bachem’s capabilities as the first CMO servicing the global TIDES market.

September 21, 12:05pm

Main Conference Presentation

Speaker

Stefan Eissler, PhD, Director, API Manufacturing at Bachem AG

Stefan Eissler, Ph.D., joined Bachem AG in 2010 after a doctorate in Organic Chemistry (Synthesis of Cryptophycins for SAR Studies) at Bielefeld University, Germany, and a post-doc position at the Laboratory for Process Research (LPF) at the University of Zurich, Switzerland. After several positions as team leader and director in liquid phase peptide synthesis and solid phase peptide synthesis, he currently holds the position of Senior Director at Bachem AG in Bubendorf. In this position he is responsible for the large scale manufacturing of peptides.

Abstract

DMF Replacement in SPPS: Key Findings and Latest Results

The main SPPS solvent for complex peptides is DMF. Even though DMF is an excellent and well-established solvent for SPPS, replacement for a less toxic solvent (or solvent mixture) is advisable in the light of recent REACH regulations. Bachem has been working on that topic for some time now. Results have been published recently together with our cooperation partners. In this presentation, we will present our key findings and latest results.

September 23, 10:45am

 

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