Audio Interview

Challenges and solutions of scaling up

Published on March 21, 2024   8 min

Other Talks in the Playlist: Research and Clinical Interviews

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Interviewer: This is an interview with Dr. Shaukat Ali, Senior Director, Scientific Affairs and Technical Marketing Ascendia Pharma Inc. on important decisions that must be made when seeking to meet the challenges of scaling up in five key areas, solubilization, choosing excipients, selecting adjuvants, gene therapy, and nanoparticle production. For clarity, Dr. Ali has submitted written answers to my questions. Dr. Ali, thank you for taking the time to answer my questions. To get started, we all know that there are challenges when seeking to scale up from laboratory-scale production to commercial-level manufacturing. What are the particular problems and potential solutions when seeking to solve issues in solubilization? Dr. Ali: Over 80% of new molecules coming out of discovery research are poorly soluble which has resulted in a bottleneck for bringing innovative drugs to market while keeping in mind finding an appropriate technology that's easier to scale up for manufacturing from smaller R&D batches. It's a common problem that could be a complex one at a much larger scale. Thus, the pharma industry continues to struggle and is weighing all options in assessing innovative technologies easily adaptable at the continuous manufacturing level, including solid amorphous dispersions, co-precipitation, self-emulsifying drug delivery systems, long-acting injectable delivery, and drug layering