TIDES Asia (formerly AsiaTIDES) has been completely re-imagined (for 2021 only) due to the continuing pandemic. The 2021 TIDES Asia Virtual Scientific Forum is FREE to attend and consists of 4 world-renowned keynote speakers and several cutting-edge technology company and CMO speakers who will present some of the latest R&D and CMC/manufacturing developments in the field. TIDES Asia 2021 is not a virtual conference.

All speaker presentations are pre-recorded and will run as a series of webinars on JST (Japan Standard Time). The webinars will also be available on-demand post event for anyone with a scheduling conflicts, so be sure to still sign up!

DAY 1 – TUESDAY, MARCH 2, 2021



How Antisense Drugs Work: Molecular Mechanisms of Cellular Pharmacokinetics, Pharmacodynamis and Toxicity
&
N-Lorem a New Charitable Foundation: Creating Individualized Treatments for Patients with Ultra-Rare Diseases using Antisense Technology.
8:30am - 10:00am JST

How Antisense Drugs Work: Molecular Mechanisms of Cellular Pharmacokinetics, Pharmacodynamis and Toxicity

Describing the educational value of attending your webcast session Antisense technology is beginning to deliver on the broad therapeutic promise of three decades and the technology continues to advance at a rapid pace yielding ever better performing therapeutic agents. The technology has progressed to this exciting moment and continues to advance because of long term investment in basic research into the technology itself. Today, the molecular mechanisms by which PS ASOs enter and distribute in cells, the molecular mechanisms of action and molecular mechanisms of toxicity are well understood and provide the basic understanding to use medicinal chemistry to enhance their performance and versatility even more. In this presentation we focus not on what PS ASOs do, but how and why they do what they do and look to the future of the technology to be shaped by todays knowledge.

Speaker:

Stanley T. Crooke, M.D., Ph.D.
Executive Chairman
Ionis Pharmaceuticals


N-Lorem a New Charitable Foundation: Creating Individualized Treatments for Patients with Ultra-Rare Diseases using Antisense Technology.>

Describing the educational value of attending your webcast session n-Lorem is a charitable foundation that is bringing experimental ASO treatments to patients with ultra-rare diseases (n: 1-30 worldwide) for free for life. Though each patient may be unique or a member of a very small cohort of patients, in aggregate there are millions of such patients identified worldwide. To do this n-Lorem collaborates with Ionis Pharmaceuticals to create precision ASOs designed to address the specific mutation of each patient, one patient at a time. n-Lorem has systems that assure that patients are exposed to only prudent risks and importantly n-Lorem plans to publish the results of our efforts in scientific literature annually. in n-Lorem currently focuses on patients with mutations that cause symptoms in the CNS (I.T. dosing), the liver or kidney (SC dosing), the lung (aerosol dosing) and the eye (Intravitreal dosing) as for these organs Ionis has substantial experience, the doses needed are low and there are substantial safety margins, for ASOs used in these organs. In our first year of operation, we have helped two investigators treat >10 patients with several neurological diseases with experimental ASOs and received more than 50 applications for treatment and proceeding to create experimental ASO treatments for >20 patients.

Speaker:

Stanley T. Crooke, M.D., Ph.D.
Chairman and CEO
n-Lorem

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Oligonucleotide Manufacturing from Small to Large Scale
10:00am JST

Oligonucleotide therapeutics has been one of the hottest drug discovery area. The number of approved drugs is tripled over the past five years.

However, with this developing market comes some considerable challenges for drug manufacturers in the ability to cost effectively, quickly and easily scale from research-use amounts to commercial needs.

In this presentation you can understand how Ajinomoto Bio-Pharma Services meets this seamless supply challenge by providing development, scale-up and synthesis capabilities of research to commercial quantities of customized oligonucleotides.

Speaker:

Toru Okamatsu
Acting General Manager of Business Development
Ajinomoto Bio-Pharma Services Osaka

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Advancing and enabling commercial-scale manufacturing of nucleic acid based medicine
11:00am JST

As a worldwide leader in serving science, Thermo Fisher Scientific invites you to explore our portfolio of high-quality reagents designed for your oligonucleotide and mRNA synthesis.  We will review the advances in mRNA Cap, manufacturing innovation and scaling to support global demand in raw material for nucleic acid therapeutics.

Speaker:

Anil Kore, Ph.D.
Director Chemistry
Thermo Fisher Scientific

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DAY 2 – WEDNESDAY, MARCH 3, 2021



A Strategic Vision for Therapeutic Development: The PeptiDream Story
9:00am JST

This presentation will provide an overview of the strategic vision and business philosophy that has guided PeptiDream’s evolution into one of the leading peptide drug discovery and development companies in the field.

Speaker:

Patrick C. Reid Ph.D.
President, CEO and Chairman of the Board
PeptiDream, Inc.

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Microspheres and Nanoparticles for Peptide Delivery
10:00am JST

Delivery of peptides is a challenging task due to their poor stability toward proteolytic enzymes, their large size and poor penetration into cells. The great innovation in this field relies on the formulation of microspheres and nanoparticles to encapsulate the peptide in order to enhance its bioavailability and therapeutic efficacy. Microparticle formulation has been successfully applied in a number of commercial products containing peptides as active pharmaceutical ingredients. The use of nanoparticles for delivering proteins and peptides are still in early stages of development and is expected to mature in near future.

Speaker:

Jyothi Thundimadathil, PhD
Associate Director
Bachem Americas

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Solubility-directed Development of Trileucine Process
11:00am JST

The excipient Trileucine is applied for improving aerosol performance and stability of spray-dried powders for inhalation. The peptide Trileucine can form different polymorphs, which show large variations in water solubility. In this presentation, the development of a new and straightforward manufacturing process in solution is shown. Based on the results of a polymorph screening study, Trileucine material with optimal solubility properties in water was obtained.

Speaker:

Wolfgang Seufert, PhD
Director Production
Bachem AG

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GC-LPPS: Aspen’s Green Continuous Liquid Phase Peptide Synthesis – Green, Lean and Clean
12:00pm JST

Aspen API has developed a Green Continuous Liquid Phase Peptide Synthesis, which combines the advantages of classical solution-phase synthesis and solid-phase synthesis. The process consists of repetitive cycles of coupling and deprotection in a permanent green organic phase (ethyl acetate), in which the growing peptide is anchored due to the presence of hydrophobic protecting functions. It is further characterized by the fact that intermediates are not isolated. These distinctive features account for a significant reduction of organic waste streams with respect to the classical methods of peptide synthesis. Processes according to this highly efficient synthesis method are easy to scale up and yield products of reproducible high purity.

Speaker:

Ivo Eggen
Section Lead
Aspen API

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Diastereomer control strategy - Teriparatide Case study
1:00pm JST

Teriparatide (PTH 1-34) is a peptide hormone utilized for the treatment of osteoporosis. In this case study, analytical control strategy considerations are discussed in traversing from the innovators recombinant (bio-synthetic) PTH 1-34 to chemically synthesized PTH 1-34 (solid phase peptide synthesis). Special emphasis is given on the control of diastereomer impurities in relation to recent regulatory expectations. Batch analysis characterization data combined with a risk assessment was performed to understand the occurrence of diastereomers within the sequence of PTH 1-34 and to demonstrate the detectability and utility of the process and analytical control strategy in ensuring a highly purified drug substance, with diastereomers controlled below specified limits.

Speaker:

Eran J. Benjamin Ph.D.
Global director QC AD
PolyPeptide Group, Torrance CA

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DAY 3 – THURSDAY, MARCH 4, 2021



RNA Therapeutics: Importance of Nucleotide Sequence and Modifications on the Mechanism of Action
9:00am JST

Describing the educational value of attending your webcast session RNA Therapeutics are finally taking their place as a main drug platform alongside small molecules and proteins. In this platform drug candidates are composed of modified synthetic oligonucleotides. While the intended target of these compounds is RNA, they can also be recognized by pattern recognition receptors. I will discuss the twists and turns on their road to success and highlight areas of ongoing research.

Speaker:

Sudhir Agrawal, D.Phil
Founder and President
Arnay Sciences

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Preparative Separation of Oligonucleotide by Ion-Exchange and Hydrophobic Interaction Chromatography
10:00 AM JST

Production capacity for synthetic oligonucleotides are becoming more important and critical due to increase in global demand. While preparative separation of oligonucleotide is well applied by reversed-phase chromatography (RPC), RPC using organic solvents has problems in safety in production facility and environmental protection. To overcome these problems, ion-exchange chromatography (IEC) and hydrophobic interaction chromatography (HIC) would be considered with aqueous eluent and with less organic solvent. Recent application to oligonucleotide by IEC and HIC will be discussed.

Speaker:

Yosuke (Oscar) Yamasaki
Marketing Department, Product Management Unit
Bioscience Division
Tosoh corporation

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Sample Preparation Strategies for Oligonucleotide Bioanalytical Workflows
11:00 AM JST

In this presentation, we will give an overview of sample preparation strategies for synthetic oligonucleotides, including how to adjust experimental design depending on the oligo and sample matrix. Additionally, we will discuss approaches for other challenging oligos, such as peptide nucleic acids or morpholinos, which are unique in that they do not have the negatively charged backbone associated with other nucleic acid chemistries.

Speaker:

Brian Rivera
Senior Product Manager – Biologics
Phenomenex

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New Oligonucleotide GMP Manufacturing Facility from API to Filling & Finishing
12:00 PM JST

Guangzhou RiboBio Co., Ltd (RiboBio), founded in 2004, is a leading nucleic acids-based biotech company in China. RiboBio established a comprehensive oligonucleotide manufacturing facility that supports small to large scale GMP production. RiboBio has a state-of-the-art analytical lab accommodating various analytical instruments.

In 2013, RiboBio built the first GMP oligonucleotide manufacturing facility in China and was issued the Oligo API Drug Manufacturing Permit by the CFDA in June 2016. Currently, RiboBio completed its expansion project in 2020 which is now operating. A large-scale API GMP manufacturing facility and an aseptic fill/finish facility with approximately 10,000 sq. meters of production space, equipped with 2 synthesis skids, 3 purification suites, and one 3 in 1 filling/finishing line with RABS.

Speaker:

Michael Zhang
BD Mangaer
Guangzhou RiboBio Co., Ltd (RiboBio)

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DAY 4 – FRIDAY, MARCH 5, 2021



Usage of an mRNA Platform Technology for “Light Speed” Development of a Vaccine against SARS-CoV-2”
9:00am JST

Describing the educational value of attending your webcast session Messenger (m)RNA is increasingly investigated as a platform technology for multiple therapeutic applications including as a vaccine against infectious diseases. With respect to manufacturing, mRNA has several advantages compared to other biopharmaceuticals. Most importantly, one process can be essentially used to manufacture any RNA sequence, significantly shortening development time for a new project. With the recent outbreak of COVID-19, our mRNA platform was thus ideally suited to develop an mRNA-based vaccine in “light speed”. In this talk, the approach that was used and the current status will be presented.

Speaker:

Andreas Kuhn, Ph.D.
Senior Vice President RNA Biochemistry & Manufacturing
BioNTech RNA Pharmaceuticals GmbH

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LGC’s Development of a Novel, Modular, GalNAc Access, and Conjugation Strategies for Nucleic Acid Medicines
10:00am JST

Which GalNAc ligand you want to choose? LGC Nucleic Acid Chemistry (NAC) group enables a novel, modular access to a proprietary GalNAc ligand system without affecting the phosphate backbone of the corresponding oligonucleotide. It takes advantage of the sugar unit (deoxyribose) utilised to naturally fit into the sugar-phosphate backbone, and, beyond, since it is a proprietary technology, it avoids complicated IP negotiations with 3rd parties. LGC Nucleic Acid Therapeutics unit (NAT) offers multiple conjugation strategies on solid support or post synthesis depending on the respective GalNAc system chosen. Direct access to LGC’s in-house developed GalNAc ligand reduces the burden for external sourcing efforts. A brief introduction of LGC’s NAT group services and LGC’s NAC group products and locations is given.

Speakers:

Dr. Catherine McKeen
Site Operational Director & Head of Chemistry
LGC

Dr. Juergen Mueller
Commercial & Strategic Development Director Oligo-Therapeutics
LGC Axolabs

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CMC Considerations for mRNA Based Therapeutics
11:00am JST

mRNA characterisation and analysis is a critical requirement to assess drug product or drug substance quality and efficacy. The complex approach to manufacturing mRNA as well as the intracellular delivery method can bring impurity risks that impact the efficacy and safety of the drug. This presentation discusses analytical approaches to characterise mRNA in early-stage development to support effective therapeutic programs including specification tests for batch release and stability study testing of mRNA drug substances and drug products.

Speakers:

Ashleigh Wake
Business Development Director, UK
Intertek Pharmaceutical Services

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