Panel discussion: From formulation development to commercialisation of complex generics: Challenges and mitigation strategies

FDD Conclave, a one-of-its-kind platform for formulation development and drug delivery professionals, is a thought leadership forum which aims to facilitate sustained progress for India’s pharma sector and take it to greater heights. Therefore, in its recently held third edition, several crucial topics which are very relevant to the current scenario in FR&D were discussed and deliberated upon by experts and veterans of this industry. ‘From formulation development to commercialisation of complex generics: Challenges and mitigation strategies’ was one such topic under discussion. The esteemed panelists for this discussion were Dr Pavan Bhat, Executive Vice President – Technical Operations, Natco Pharma; Dr Girish Jain, Head – Global R&D, Slayback Pharma; Dr Rakesh Bhasin, Vice President – Generic Formulation, Biocon and Dr Ramakrishna Bangaru, Sr Vice President, Mylan.

Dr Bhatt, the moderator for this session, set the context for this discussion and informed that the major objective of the discussion is to examine various aspects of complex formulation development, understand the challenges and discuss strategies to deal with them effectively. He pointed out that Indian pharma is developing and successfully filing a lot of modified release products and probably experiencing a lot of issues post e-batches and hence the idea was to examine the whole process, share learnings and take them to their work labs for better results.

Each of the panelists shared some examples from their own experience and the lessons from each of these instances. They also deliberated on appropriate designs for development of complex formulations and also examined issues that are being addressed, post approval, during commercialisation. They advised that it is important to take every single detail ranging from material attributes and process controls to product quality into account while developing complex formulations. Even the smallest of deviations, like humidity levels in the input
atmospheric air, can put the efficiency and efficacy of the product at risk.

The panelists unanimously urged the industry to adopt QbD in a big way to ensure reproducibility and robustness of processes and products, thereby effectively leveraging the opportunities in complex formulations.

The discussion also touched upon the fact that regulatory agencies have increased their scrutiny and ask for a lot of data nowadays. Hence, experts advised pharma companies to anticipate these demands and characterise their products completely to optimise time and efforts as well as ensure better compliance. They cautioned the audience that a step taken at the right time can save a lot of time and money in future. Design the right systems and think long-term was their recommendation.

Key takeaways for those involved in development of future modified released products were procure right, choose the apt equipment, put a rigorous monitoring system in place, design and implement an extensive bioequivalence study, anticipate regulatory demands and think innovatively to become a leader in complex formulations.