The group focuses on drug product formulation and manufacturing processes; including solid, semi-solid and liquid dosage forms. Established processing operations (e.g. mixing, comminution, granulation and compaction) and new formulation and process technology approaches are in scope. Further interests include Quality by Design strategies, PAT applications, and Quality Risk assessments that demonstrate product and process understanding to the regulatory authorities.
The Focus Group steering committee has representation from industrial scientists in a number of large pharma companies including Pfizer, GSK, AstraZeneca and Bristol-Myers Squibb; academics from De Montfort and Leeds Universities; and specialist technology companies such as Colorcon. Focus Group members are participants in a number of cross-academia and cross-industry collaborations.
ADDoPT (Advanced Digital Design of Pharmaceutical Technologies)
Leane M, Pitt KG, Reynolds GK, Dawson N, Ziegler I, Szepes A, Crean AM , Agnol RD. Manufacturing Classification System in the real world: factors influencing manufacturing process choices for filed commercial oral solid dosage formulations, case studies from industry and considerations for continuous processing Pharmaceutical Development and Technology 2018 https://www.tandfonline.com/doi/abs/10.1080/10837450.2018.1534863
The Focus Group will promote scientific education and training in the field of PEPF to meet the needs of scientists and engineers working in both industrial and academic sectors. The Focus Group will provide an active community of practice for those interested in the science of formulation and process development, and through this network seek to develop opportunities for cross-sector pre-competitive collaboration. The Focus Group will contribute to the scientific programme for the annual APS PharmSci meeting and organise additional symposia to promote awareness of innovative approaches for formulation and process development.
Dr. Stuart Charlton is an Associate Scientific Director in Drug Product Development at Bristol Myers Squibb, focused on oral drug product development. He has been a member of the APS for over 15 years and is co-lead of the Process Engineering and Formulation Focus Group. Stuart graduated from the University of Bath with a degree in Pharmacy, and was later awarded a PhD by the University of Nottingham in 2002. Stuart is particularly interested in paediatric drug product development, and is engaged in projects and initiatives across the company and externally. Other research interests include mechanistic understanding and mini-piloting techniques for roller compaction and film-coating.
Dr. Ranjit Dhenge is Investigator in the Product Development and Supply group at GlaxoSmithKline (GSK) R&D (Ware, UK). He is also Associate Fellow at GSK and co-chair of APS’s Process Engineering and Formulation focus group.
Ranjit is PhD from The University of Sheffield, UK where he also worked as Post- Doctoral Researcher in the area of Continuous Pharmaceutical Granulation with special attention to process development. Ranjit’s current focus at GSK is on platform and process development of dry granulation operation (roller compaction). This involves developing small scale prediction tools, modelling framework and application of tools into the projects. The work also involves technical troubleshooting and process de-risking.
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