Join us June 1-4, 2020 for TIDES Digital Week, a global 4-day series of live educational webcasts and downloadable resources providing the latest insights for accelerating oligonucleotide and peptide products to commercial success. To sponsor future digital events, contact partners@informaconnectls.com

DAY 1 – MONDAY, JUNE 1, 2020

Oligonucleotide Discovery and Development



Mobile Phase Optimization for Oligonucleotide Analytical Methods by LC-MS
10am EDT / 3pm BST / 4pm CEST

The use of alkylamine ion pair and perfluorinated alcohols in the analysis of oligonucleotides by LC-MS techniques has been the mainstay in characterization and quantitation methods for synthetic oligonucleotides for decades. Often, analytical chemists default to relatively high concentrations of both. But how much ion pair is needed for optimal chromatographic performance? How much does perfluorinated alcohol concentration contribute to electrospray ionization efficiency? In this presentation, we explore modulation of both mobile phase additives, including different options for alkylamine ion pair outside of the commonly used triethylamine.

Speaker:

Brian Rivera
Bioseparations Product Manager
Phenomenex

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Prophylactic and Therapeutic Applications of mRNA Technology for Infectious Diseases
11am EDT / 4pm BST / 5pm CEST

This presentation will provide case -history examples of the Moderna mRNA technology platform for the development of prophylactic vaccines and in situ production of neutralizing antibodies for passive immunity/therapeutic applications.

Speaker:

James Thompson, Ph.
CMC Therapeutic Area Lead
Moderna Therapeutics

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Overcome Sensitivity Challenges in Oligonucleotide Bioanalysis
12pm EDT / 5pm BST / 6pm CEST

You will learn LC-MS solutions to accelerate your oligonucleotide therapeutics development.

  • Single ng/mL LOQ
  • Robust Platform for High-Throughput Analysis
  • Flexible and Compliant Data Processing

Speaker:

Esme Candish, Ph.D.
Biopharma Application Scientist
SCIEX

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Day 2- TUESDAY, JUNE 2, 2020

CMC and Manufacturing: Oligonucleotides and Peptides



New Findings in The Amide Bond Forming Conditions Typically Used in The Peptide Manufacturing Industry
10am EDT / 3pm BST / 4pm CEST

Since the invention of the solid phase peptide synthesis (SPPS) by Merrifield more than 5 decades ago, the technology to make peptides has evolved dramatically. The coupling reaction, so essential to making an amide bond, traditionally had the sole objectives of forming the amide bond effectively, i.e. going to completion, while limiting racemization. Lately, a lot of attention has been given to additional aspects of the coupling reaction in terms of process understanding, greening - hereunder EHS perspectives - as well as control of side reactions. Using in-house examples, this presentation will picture the new insights of the complex coupling reaction.

Speaker:

Jon Rasmussen
Global Director of Development
PolyPeptide Group

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The Use of Parallel Peptide Synthesizers in The Manufacture of Long and Complex Peptides and High Throughput Manufacture with an Intro from Andrew Kennedy Ph.D, Global Product Manager at Gyros Protein Technologies
Description: 11am EDT / 4pm BST / 5pm CEST

Reliance on Solid Phase Peptide Synthesis has increased dramatically over the decades to keep pace with the rise in the use of peptides in diagnostic and therapeutic research. In parallel, approaches to automated synthesis have evolved in order to be compatible with a diverse range of coupling chemistries, reaction conditions and synthesis monitoring. Automated peptide synthesises must be reliable, robust, fast, and easy to use.
Almac as a peptide CMO, has used parallel synthesisers for more than 15 years. In that time, we have developed methodology to manufacture very long and complex peptides, and we will present some examples in this field. More recently, we have applied automated parallel synthesisers in a GMP setting in the manufacture of clinical grade peptides for use in vaccine products.

Speaker:

Alastair Hay
Account Manager – Peptides
Almac Group Ltd

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Liquid Phase Synthesis of Oligonucleotides
12pm EDT / 5pm BST / 6pm CEST

Solid phase synthesis offers rapid synthesis of oligos and is the dominant technology at present. The attachment of the growing oligo to the solid phase enables effective separation of molecular debris during the coupling cycle. However, it is difficult to monitor the reaction progress, mass transfer resistances inside the resin can make achieving complete reactions difficult, and when it’s time to increase capacity, numbering out of synthesizers or scale up of packed beds is required. This talk will present Nanostar Sieving, an alternative approach in which two or more growing oligos are linked to a hub molecule, forming a high molecular weight, macro-molecular nanostar. This nanostar is soluble, and is readily separated from molecular debris using a solvent stable nanofiltration membrane. The coupling cycles are carried out entirely in the liquid phase, with diafiltration to remove debris at each coupling and deprotection step. This allows further building block or other reagents to be added at each cycle, if any incomplete reaction is detected, and generally promotes a high degree of in-line quality control using uPLC-MS and other analytical techniques. The synthesis of a 2'-methyl RNA phosphorothioate 20 mer sequence using this approach at the 10-20 mmol (50-100 g) scale will be discussed, and the high purity of the crude material produced by Nanostar Sieving compared to the purity obtained by solid phase synthesis with similar excesses of phosphoramidites. Scale-up from the 1-2 g scale to the 50-100g scale has been achieved with spiral wound membrane modules and will be described with an approximate economic comparison made with solid phase synthesis.

Speaker:

Andrew Livingston, Ph.D.
Professor of Chemical Engineering
Queen Mary University of London

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Day 3 - WEDNESDAY, JUNE 3, 2020

mRNA Therapeutics and Vaccines



Development of a Quality Control Strategy for Vaccines
10am EST / 3pm BST / 4pm CEST

Join the session to learn how to create and manage an effective strategy for vaccines

Speaker:

Ashleigh Wake
Technical Expert
Intertek

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Individualized Neoantigen-Specific Therapy Against Cancer Using Messenger RNA
11am EDT / 4pm BST / 5pm CEST

One of the obviously biggest challenges in fighting cancer is that every patient has a unique cancer. One reasonable approach to overcome this is to target the unique molecular signature of each cancer and to adapt treatment to the patient’s disease and immune system dynamics. To deliver the genetic information of antigens into antigen-presenting dendritic cells of the immune system the mRNA platform technology offers plenty of new options. The presentation will deal with conducting a clinical trial with a neoantigen-specific therapy using mRNA.

Speaker:

Christoph Kröner, Ph.D.
Head of Lead Structure and DNA Template Development for Individualized RNA Products
BioNTech AG

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Day 4 - THURSDAY, JUNE 4, 2020

Peptide Therapeutics: Discovery, CMC and Manufacturing



High-throughput Identification of Intracellular Targets for Solid Tumors
10am EDT / 3pm BST / 4pm CEST

Target identification in solid tumors can help enable therapeutic development against indications of high unmet need and across a wide patient population. Checkpoint therapy has shown that CD8+ T cells are responsible for driving patient responses, and yet the specificities of these T cells cannot be directly determined in an unbiased manner. We have developed a high-throughput platform to directly determine the specificities of clonally enriched and shared patient T cell responses. This information can be used to link clinical responses, immune biomarkers, and T cell specificities to evaluate the most promising shared targets in solid tumors and understand the mechanism of action of current anticancer drugs. These targets can be used to develop T cell therapies or other therapeutic modalities that can be used to improve the outcomes of clinical treatment in an array of solid tumor indications.

Speaker:

Marvin Gee Ph.D.
Co-Founder and Head of Target
3T Biosciences

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Green Solid-Phase Peptide Synthesis, Closing the Gap with the Conventional Strategies
11am EDT / 4pm BST / 5pm CEST

Solid-phase is the methodology of choice for the synthesis of peptides in both industrial and research modes. In this presentation, we will demonstrate that the use of green solvents as a replacement of reprotoxic DMF and DCM does not hamper at all the synthetic process, but it rather makes it environmentally friendlier and better.

Speaker:

Fernando Albericio, Ph.D.
Research Professor, School of Chemistry
University of Kwazulu-Natal

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Breaking Bottlenecks: Adjusting mobile phase modifiers to improve peptide purity with minimal chromatographic method development
12pm EDT / 5pm BST / 6pm CEST

Recent technological advances enable non-biased screening of tens of millions of peptidic compounds containing natural or non-natural amino acids and frequently secondary chemistries, further expanding the use of peptides in drug discovery campaigns. While many automated synthesis platforms can expedite the follow up synthesis demands, peptide purification often creates a bottleneck, slowing delivery of the final purified compounds for evaluation. High Performance Flash Chromatography (HPFC) is gaining traction within the peptide community as a strategy to reduce the impact of the purification bottleneck, primarily due to the flash column’s larger column loading capacity In today’s presentation, attendees will learn how changes to the mobile phase modifier impact selectivity for the desired peptide, leading to a highly pure sample while minimizing the time committed to chromatographic method development.

Speaker:

Elizabeth Denton, Ph.D.
Sr. Scientist, Peptide Chemistry
Biotage

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