Process Development of New Chemical Entities — Overcoming Challenges of Safety and Quality for a Seamless Technology Transfer

Life Sciences, Pharmaceutical Regulation, Pharma Manufacturing & Supply Chain,
  • Thursday, July 25, 2024 | 11am EDT (NA) / 4pm BST (UK) / 5pm CEST (EU-Central)
  • 60 min

Discover an informative webinar focusing on the latest developments in chemical manufacturing and innovative techniques that can be used for the efficient, sustainable development of new chemical entities.

Right from pre-clinical to clinical to commercial deliveries, the expert speakers will discuss about how to make phase-appropriate development decisions while keeping safety and quality at the center, particularly during technology transfer, to ensure that delivered products meet all quality attributes. They will also highlight the latest advancements, innovative techniques and practical applications to enhance efficiency and sustainability in chemical manufacturing of new chemical entities.

Moreover, they will address the important elements of a process development program designed to support the establishment of a robust process that aligns with product progression through clinical trials. They will also cover the adoption of a holistic approach to process development and emphasize the safety, quality and anticipation of future development needs. Finally, strategies for managing risks, in addition to making necessary compromises and trade-offs to accelerate the process development program, will be explored.

Register for this webinar today to gain insights from expert speakers on the process development of new chemical entities and learn about the latest advancements and innovative techniques in chemical manufacturing.

Speakers

Mr. Kumaran Moghilly, Aragen Life Sciences Ltd

Mr. Kumaran Moghilly, Associate Vice President, Manufacturing Site Head, Aragen Life Sciences Ltd

Mr. Kumaran Moghilly is the current Manufacturing Site Head, leveraging his experience from previous roles at Biocon and Dr. Reddy’s Laboratories Ltd. He earned an MBA in Manufacturing Management from Birla Institute of Technology and Science, Pilani (2015-2017). With expertise in validation, life sciences, SOPs, biotechnology and GMP, Mr. Kumaran brings valuable insights to the industry.

Message Presenter
Dr. Lokesh S Pawar, Aragen Life Sciences Ltd

Dr. Lokesh S Pawar, Senior Director, Aragen Life Sciences Ltd

Dr. Lokesh S Pawar has more than 17 years of industrial and nine years of academic experience in research and development. Having worked for major CRO, drug discovery and PR&D companies, he has experience in designing synthetic routes for medicinally active and custom organic molecules. He also has experience in the synthesis and scale-up of medicinally active and complex organic molecules, as well as in method development, process development and handling of NMR, LCMS, HPLC, GCMS, UV-Vis, FTIR, DSC and TGA data.

Message Presenter
N Sreedhar Gupta, Aragen Life Sciences Ltd

N Sreedhar Gupta, Deputy General Manager, QA and DQA, Aragen Life Sciences Ltd

N Sreedhar Gupta has more than 18 years of experience in different areas of the pharma industry (OSD, Sterile & API R&D). He also has experience in quality management systems, document control, audit and compliance, vendor qualification, review and evaluation of analytical systems and implementation of 21 CFR part 11 compliance.

Message Presenter

Who Should Attend?

This webinar will appeal to:

  • Clinical Research/Formulation/Process Development/Pharmaceutical Scientist
  • Process Safety/Bioprocess/Validation/Chemical Engineer
  • Production/Lab/Project/R&D Manager
  • Technical Operations/Quality Assurance Manager
  • Technology Transfer/Safety/Regulatory Affairs Specialist
  • Manufacturing Site Head
  • Analytical Chemist

What You Will Learn

Attendees will learn about:

  • The essential elements of a process development program to support developing a robust process in line with the product progression in clinical trials
  • How to ensure quality and safety as integral parts with technology transfer to ensure delivery of products meet quality attributes
  • How to take a holistic approach to developing processes with an eye on safety, quality and future development
  • How to manage risk, make compromises and trade-offs to expedite your process development program

Xtalks Partner

Aragen Life Sciences

Aragen Life Sciences is a leading R&D and manufacturing solutions provider for the life sciences industries worldwide. It offers end-to-end integrated or standalone solutions for small and large molecules. Established in 2001, the Company operates through a network of sites located globally with a team of 3700+ scientists and 450+ PhDs. Its expertise and experience have enabled over 400 customers to advance their research programs from discovery through commercialization. Aragen’s innovative mindset, infrastructure, flexible business models have enabled us to serve large pharma, biotech, agrochemical, animal health and performance chemical industries globally. Visit www.aragen.com for more details

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