Who we are

Process Engineering and Formulation Focus Group.

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.

Examples include:

ADDoPT (Advanced Digital Design of Pharmaceutical Technologies)

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Manufacturing Classification System (MCS) working party.

Take a look at the papers published

Leane M, Pitt KG, Reynolds G. A Proposal for a Drug Product Manufacturing Classification System (MCS) for Oral Solid Dosage Forms. Pharmaceutical Development and Technology 2015; 20: 12-21 . .http://informahealthcare.com/doi/abs/10.3109/10837450.2014.954728

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

Paediatric Initiative.

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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.

I am interested in formulation and process design and putting numbers to phenomena to get medicines to the patient as readily as possible. Hence why I joined PEPF Focus Group and so have the opportunity to meet like-minded individuals.”

“The PEPF Focus Group is perfectly aligned to my role as a formulation scientist, striving for greater understanding of established and new formulations and manufacturing processes. The group offers excellent opportunities for networking and collaborations; and is a forum to discuss activities and advances across industry, academia, vendors and regulatory agencies.”

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