Executive Vice President & Head
API R&D at Dr. Reddy’s Laboratories Limited, Hyderabad
Rajeev is currently working as Executive Vice President & Head – API R&D at Dr. Reddy’s Laboratories Limited, Hyderabad. He holds a Masters and a Ph.D. degree in Organic Chemistry from Maharaja Sayajirao (M.S.) University of Baroda. He brings with him over 30 years of experience in the areas of academic research at M.S.University, followed by Process Chemistry of generic APIs at Sun Pharma’s R&D centre at Baroda, leading to numerous DMF/ANDA filings for a gamut of molecules of varying complexities, including Peptides. Rajeev is very passionate about R&D collaboration cutting across cross-functional domains, both within and outside the company, including external subject matter experts. He also has a number of patent publications to his credit and has delivered talks on emerging frontiers in Pharma Science and Technology.
In this Webinar, Dr. Rajeev Rehani Budhdev, Executive Vice President & Head – of API R&D, Dr. Reddy's Laboratories Limited, speaks about peptide capabilities – Research and development, quality control, synthesis, purification, complex characterization techniques, cGMP manufacturing facilities, and regulatory prerequisites accompanied by live case studies.
In the introduction of the webinar, Dr. Rajeev emphasizes the peptide market overview that includes the global pharmaceutical market of peptides, peptide portfolio and capabilities in synthesizing complex peptides, peptide API manufacturing, and Dr. Reddy's expertise in handling peptides – peptide drug development, discovery, and chemical synthesis.
The following section covers the various steps to overcome the challenges of solid-phase peptide synthesis, identification, and quantification of peptide-related impurities in peptide manufacturing. Unique approaches in peptide synthesis - technology used in peptide development, solid-phase synthesis, purification, product isolation, peptide workflow, complex characterization techniques, packaging storage, and transport.
In the next section, Dr. Rajeev provides insights on analytical and regulatory approaches - analytical attributes, peptide API manufacturing, the interplay of physicochemical and biological characterization, release specifications (tests, methods, and instrument techniques), and sameness studies. In the final section of the webinar, Dr. Rajeev shares the success story with a live case study on Semaglutide, a fully synthetic peptide API that is a notable example of peptide product development capabilities of Dr. Reddy's. This webinar section provides information on Semaglutide – Product overview, line extensions, new indications, capabilities, regulatory strategy, and availability, followed by a Q&A session.
Dr. Reddy's is well-positioned to support its API customers with APIs and services for peptides with extensive peptide development capabilities. It is leveraged based on state-of-the-art process development facilities, supported by formulation optimization platforms and cGMP manufacturing capabilities. We provide a unique end-to-end product offering for Semaglutide that includes the business models - API purchase, API + device purchase, a combination of API and Salcaprozpate sodium (SNAC) for oral formulation and finished formulations purchase, etc.
To know more about how we can meet your peptide formulation requirements, contact us at: email@example.com.