Delivering the Added Dimension in Scale-up - Webinar by Jubilant Biosys
Jubilant Biosys will be conducting a webinar to discuss the transformation needed in decision-making, assessment, and bringing in scale-up expertise earlier than typically done through PR&D scientists.
By: Jubilant Biosys
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. This can work with moderately complex routes but in recent years the majority of the candidates are the result of lengthy and complex synthetic schemes.
In addition, we offer a platform for all attendants to share their best practices and experience so IND submission can be accelerated with better chemistry and technology decisions including the right focus on process impurities in human trials.
Common assumptions seen in practices:
· Why lose time on a new route? "We need it fast, let us make it this way"
· "My route is better"
· Medicinal chemists have been seen to be satisfied with their route in 70 % of the cases (what is the source of this statement?)
Foreseeable Engineering & Technology aspect:
· Need for Column chromatography
· Use of SFC – rather an avoidance of it
· Isolation issues and other purification aspects
Foreseeable regulatory aspects:
· The solvents & catalysts being used
· Use of cleanroom
Applicability of technology:
· Use of flow/photochemistry
· Level of details in the qualification of API – what assay level is best?
· Techniques needed for the qualification of material
· Setting up the limits for impurities, metals, OVI, moisture
· Solid-state characterization – when to do it?
Final recommendation and discussion
1. Marcel Velterop
President – Drug Discovery Services & CDMO – Jubilant Biosys Limited
2. Dr. Vikas Shirsath
Senior Vice President – Global Operations – Jubilant Biosys Limited
3. Purushotham Vandanapu
Director – Scale-up Chemistry Operations – Jubilant Biosys Limited
About Jubilant Biosys Limited:
Jubilant Biosys, a subsidiary of Jubilant Life Sciences Limited, is a Contract Research Organization with its R&D centers in India and business offices in Asia and North America. Jubilant Biosys specializes in comprehensive drug discovery services for the global pharmaceutical industry.
With having strong clinical development, Jubilant Biosys has risen as a fully integrated contract research organization in India (https://www.jubilantbiosys.com/
For more info: www.jubilantbiosys.com