Dr Sachin Patil, Associate VP, AR&D, Caplin Steriles addressed a very crucial topic at ADL Conclave 2022. He spoke in detail on analytical strategies for complex therapeutics. Dr Patil shared insights gained from over 18 years of experience in analytical method development in the pharma industry and characterisation of different complex drug delivery systems with data interpretation and satisfactory response to regulatory agencies.
His session emphasised on the importance of reliable, robust analytical methods for successful drug development and commercialisation of complex therapeutics. He spoke on the role of method development, qualification, and validation in understanding the critical quality attributes of the molecules of complex drugs and biologics.
He also drew attention to the CMC issues in analytical methodologies that include lack of standardised analytical methodologies for characterisation of complex products in his session. Highlighting that the requirements of the FDA mentioned in the product specific guidelines are very extensive, he emphasised that it is important to meet those requirements before submitting the dossier.
He pointed out that novel, more discriminative methodologies developed by the industry are not accepted by the agency since they don’t match USP and urged the industry to look closely at regulatory requirements while developing
analytical methods for complex therapeutics.
He advised that analytical method development for complex formulations should consider sample viscosity, sample dilution, particle refractive index and sample temperature to get the best outcomes.