FDD Conclave 2019 focussed on the theme, ‘Preparing for the next frontiers in FDD’. And, a great deal of being future-ready involves optimising our current systems, adopting best practices and expanding our capabilities. Therefore, a panel discussion titled, ‘Bridging the gap between exhibit batches and day-to-day manufacturing’; focussed on oft-encountered challenges during scale-up of exhibit batches and the methods to deal with them.
The main role of an R&D formulation and drug delivery scientist is to research, develop and optimise product formulations to fulfill the company’s market strategy. And, a crucial part of this role is to ensure these formulations adhere to regulatory mandates for patient safety, efficacy and quality. But, often during scale-up of the exhibit batches, several glitches are encountered which can delay commercialisation and cause loss of time and money.
Hence, the panelists in this session, N Ravikumar, Senior Vice President -Formulation Development, MSN Laboratories; Kiran AV, Head – R&D, Sanofi India; Sandhya Shenoy, Associate Vice President, FDC; and Sapna Ramesh, Associate Vice President, Indoco Remedies shared their inferences and learnings from their considerable experience as formulation development scientists to explore more strategies which will help in glitch-free scaling up and commercialisation of exhibit batches.
They shared several case studies which highlighted some of the common errors that FR&D professionals make and recommended their peers to choose the right processes and optimise the resources. At the same time, they also highlighted how pivotal it is to collaborate with internal teams to avoid any flaws and problems in scale up. They were emphatic that only through cooperation can these issues be tackled effectively.
They also advised setting up the right specifications to meet dissolution requirements and stressed that the onus of designing and devising robust processes lie with the formulation scientists first. The experts also elaborated on the help rendered by QbD in tackling many of these challenges.
Another takeway from this discussion was that technology transfer should be done in the utmost scientific manner to smoothen the commercialisation process. The experts
recommended formulation scientists to work with the manufacturing teams to ensure
that the gaps in scale up are mitigated. The panelists unanimously emphasised that it is
important to identify and anticipate gaps in the formulation stage and devise strategies to resolve them to bridge the gaps between exhibit batches and day-to-day manufacturing. They advised their peers to document them properly so that they can be avoided during manufacturing and commercialisation.
Thus, it was a session which had several actionable insights which would definitely help improve our formulation processes, if implemented effectively.
What are the regulatory requirements in case of batch scale down where approved batch size is less than 1,00,000 tabs. E.g. 20,000 tabs.