TIDES Asia

20 November 2024

Venue: Westin Miyako, Kyoto, Japan
Dates: 26-28 February 2025
Booth: #25

Presentations:

Workshop Co-Moderators’ Opening Remarks: Workshop #2
Robert Hagopian, Director Business Development
26 February, 9:00am

Challenges of Raw Material Acquisition for Peptide Synthesis
The increased complexity of peptides leads to the usage of new building blocks and raw materials in manufacturing of peptides for clinical application. This leads to unanticipated challenges in qualification of the vendors as well as qualification of the raw materials used in the production process. Examples will be presented including potential solutions that would help overcome these challenges.

26 Feb, 9:10am

Chairperson’s Remarks: Track 2
El Djouhar Rekaï, PhD, Head of Process & Analytical Development
27 February 10:55am and 1:40pm

Overcoming Aggregation Challenges in Peptide Manufacturing: Technical Approach and Case Studies
Peptide-based therapeutics have emerged as a significant class of drugs due to their specificity and efficacy. However, the synthesis of peptide presents unique challenges, particularly with respect to aggregation which can occur at various stages of production and compromise product quality, yield and bioactivity. This presentation explores the critical issue of aggregation in peptide synthesis focusing on the influence of process parameters and methods to mitigate. Case studies on complex peptide sequences prone to aggregation will be shared.

27 Feb, 2:15pm

Impurities in Peptide Drug Substance and Challenges Faced during Registration (in US, EU, Brazil and China Markets) and Commercial Phase
Dinesh Parmar has 16+ year of working experience in API Regulatory affairs and currently associated with PolyPeptide Group for last 4 years. In his career he has filed 50+ USDMF and worked on critical deficiencies from various Health authorities including but not limited to US, EU, Canada, China, and South Korea. His expertise in Life cycle management of product have been helping organization to strategize the future changes in effective manner, bring quicker consensus with customer and faster approval with regulatory agencies, which results in smooth commercialization of product.

He believes Regulatory intelligence is key for business continuity and aids in keeping organization ahead of time.

27 February 11:30am