Acceleration of peptide drug substance development
On-Demand Webinar Recording - Now Available
ペプチドベースの医薬品は、毎年 400 億ドルと予測される製薬業界の重要なセグメントです。治療効果と標的選択性の向上は、特に腫瘍学と代謝性疾患におけるペプチドベースの治療の成長を後押ししてきました。その結果、ペプチドベースの薬が製薬業界を支配しています。現在、何百ものペプチド医薬品が市場に出回っており、これは製薬上販売されているすべての医薬品の 10% に相当し、この数は今後さらに増えると予想されています。 フォーミュレーター企業の成功を支援する重要な要素は、ペプチドの開発において極めて重要な役割を果たす高品質の製品を提供することです。これは、ペプチドの合成、精製、特徴付け技術、製品の分離、梱包、輸送などのプロセスを監督し、すべての製造施設が効率的に稼働し、最新の品質、安全性、規制、および生産性の基準に従っていることを確認することで達成できます。 このウェビナーでは、研究開発、品質管理、合成、精製、複雑なキャラクタリゼーション技術、cGMP 製造施設、およびライブ ケース スタディを伴う規制の前提条件など、当社のペプチド機能について学びます。
What you
will learn:
Application of various particle engineering techniques to tailor API powder properties
The structured problem solving approach in achieving the right particle for your formulation needs
Dr. Reddy's capabilities involved in particle engineering and characterization
Speakers
Srividya Ramakrishnan
Head - Process Engineering, API R&D
Srividya Ramakrishnan earned her B.Tech from Indian Institute of Technology, Madras, and a Ph.D. from Princeton University in Chemical Engineering. With 20+ years of experience, she currently heads Process Engineering (Drug substance) at Dr. Reddy's Laboratories. She has presented her research at international conferences and has several publications and patents to her credit. She is also an ASQ-certified Six Sigma Black Belt.
Suhas Jawlekar
Process Engineering Expert, API R&D
Suhas Jawlekar is a chemical engineer from ICT, Mumbai and has 17 years of experience in the process development and scale-up of APIs. He has worked closely on crystallization, polymorph development and particle engineering aspects of APIs. He currently leadsa teamfocused on particle engineering, scale-up and flow manufacturing technologies.
Amuthan Ramar
Characterisation Expert, Analytical R&D
Amuthan graduated with a master's degree from Anna University, followed by a doctorate degree in material science from EPFL (Swiss Federal Institute of Technology) from Lausanne, Switzerland. Amuthan is now working as a solid-state characterisation expert focused onthe area of structure property correlation and leads a team of engineers. He has more than 14 years of experience in the field of solid-state characterisation. His microscopy and scattering-based analytical skills are well-known through his scientific publication and presentation.
In the webinar, experts from Dr. Reddy's - Srividya Ramakrishnan head - process engineering, API R&D, Suhas Jawlekar, process engineering expert, API R&D, and Amuthan Ramar, characterization expert, analytical R&D address the importance of API particle size on formulation success that includes application of various particle engineering techniques and API powder properties, The structured problem-solving approach in achieving the right particle for formulations and Dr. Reddy's capabilities in particle engineering and characterization.
The first section of the webinar covers the relation between pharma API powder properties and drug product attributes – particle size distribution, API formulation, mechanical properties, morphology (drug product attributes), solid form, surface properties, followed by crystal morphology, size, and surface properties.
The next section of the webinar emphasizes particle engineering technologies spectrum, PAT tools to understand crystallization (PVM, FBRM, Raman, FTIR), and particle engineering capabilities – powder processing, API formulation process, control of PSD in slurry and downstream processing.
The concluding section of the webinar showcases the case studies and success stories related to API formulation – Flowability improvement, the outcome of crystallization design, dissolution performances, and case studies on customer requirements regarding the particle size, followed by orthogonal verification for robust and faster PSD methods and image analysis.
Want to learn more about our capabilities in particle engineering and characterization? Then feel free to contact our product experts by filling the form here https://api.drreddys.com/contact-us (Or) at [email protected].
