At the end of your discovery process and having selected your lead candidate, you now need pivotal TOX batches and GMP phase 1 material for IND submission. Medicinal chemistry is done at low gram scale and the focus is finding the right molecular architecture, whereas the scale-up phase requires kilo range amounts often a 100X factor up from MedChem.
Time is of the essence and as regulatory requirements are still forgiving in this early phase the temptation is to try and brute-force the ‘MedChem’ route. The result can be a significant time loss combined with excessive cost and impurity generation leading to a frustrating experience as the chemistry does not behave the way we want it to.
We will be discussing the transformation needed in decision-making, assessment and bringing in scale-up expertise earlier than typically done through PR&D scientists.
Common assumptions seen in practices:
- Why lose time on a new route? “we need it fast, let us make it this way”
- Isolation issues and other purification aspects.
- Impurities.
- Use of flow / photochemistry?
- Solid state characterisation – when to do it?
Meet the speakers
Marcel J. Velterop, as President Drug Discovery Services & CDMO will lead Jubilant Drug Discovery Services and Contract Development & Manufacturing Organisation (CDMO) to provide an integrated solution to our life science customers from drug development to scale-up and then commercial manufacturing designed for maximum speed and compliance.
Dr. Vikas Shirsath is a creative, result oriented medicinal chemist with broad experience in drug discovery operations including medicinal, synthetic chemistry, biology and IP management with major contribution in the area of CNS therapeutics.
Mr. Vandanapu has more than 26 years of experience in Process Development of New Chemical entity and Active Pharmaceutical Ingredients. He started his career from Neuland Laboratories Ltd, Hyderabad where he worked as a Junior Chemist. Post this he was associated with Pharmed Chemicals Ltd, Bangalore, Dr.Reddy’s Laboratories Ltd, CPS, Hyderabad, Glenamark Research Centre, Navi Mumbai, Sai Advantium Pharmaceuticals Ltd, Hyderabad and AstraZeneca India Pvt Ltd, GCD, Bangalore.
