Ram Kouda
Scientific Associate Director
Ram Kouda has more than 10 years of experience of leading Validation and engineering teams in Pharmaceutical/Biopharmaceutical and Medical Device industries. Ram holds PhD in Chemical Engineering.
As an Associate Scientific Director in Amgen, Ram is leading Amgen Cleaning program as an SME, his team is supporting the assessment of Amgen clinical and Commercial Biological Molecules prior to manufacturing in Multiproduct facility. He has experience of successfully defending Validation programs as SME of different regulatory agencies in Biopharmaceutical and Medical Device industry.
Ram led several scientific initiatives supporting multiproduct manufacturing in same facility, it resulted in several industry-first scientific data and multiple Manuscripts.
DAY 2: May 29th, 2026
SESSION: Extending Visible Residue Limits to Potent Therapeutic Proteins: Replacing TOC Swab Testing with a Scientifically Justified Visual Approach
◆ Assessed whether VRL-based visual inspection can replace TOC swab testing for protein cleaning validation.
◆ Tested mAbs, fusion proteins, and BiTEs under controlled worst-case viewing conditions.
◆ Native vs Degraded protein Visual residue limit assessment.
◆ Demonstrated VRLs translate to TOC values within current acceptance limits, supporting VRL as a viable alternative.
DAY 2: October 2nd, 2025
SESSION: Immunogenicity and Permissible Daily Exposure of Cleaning-Induced Protein Fragments
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DAY 1: October 1st, 2024
SESSION: Biopharmaceutical molecule degradation during the Cleaning Process
◆ Bench Scale studies to demonstrate the Biological protein degradation during the cleaning process.
◆ Application of cleaning induced fragments in MAC(maximum allowable carryover) and acceptance limit calculation.
◆ Application of sensitive Analytical method to demonstrate greater than 99% degradation during cleaning process.
