Tableting Oily APIs
Speaker
Dr Gernot Warnke Head of R&D - JRS PHARMA
Speaker
Speaker
Speaker
Speaker
Drug product development involves various activities such as drug substance characterization, excipient selection, formulation development, process identification, process development, scale up, process robustness, technology transfer, process validation, regulatory submission and commercialization. All these steps involve fundamental science and Process Engineering application. Lot of techniques have been developed for material characterization and recently tools have been developed for process modelling for critical unit operations.
In this presentation, case studies will be presented to highlight the key principles related to formulation development and application of first principles approach for process development. Drug development activities related to late phase product development and some of the troubleshooting for critical process and formulation issues will be discussed.
Speaker
Speaker
Speaker
Speaker
Speaker
Speaker
Speaker
Speaker
Speaker
Richard Tarrant was responsible for the final QP certification of the first batch of COVID-19 vaccine to enter clinical trials in Europe, the Oxford-AstraZeneca vaccine, and provided various support in efforts relating to material supply for clinical trials and emergency use authorisation. In this talk, Richard will discuss the role of a clinical trial QP and how the small team at the Clinical BioManufacturing Facility (CBF) in Oxford were able manufacture, QP certify and release clinical trial material so rapidly and the various challenges encountered up until the point of emergency use authorisation.
Speaker
Speaker
Assuring successful aseptic manufacturing of sterile requires an understanding of the difficulties and limitations of test methods employed.
Various current methods are discussed as to their strengths and weaknesses.
Speaker
Speaker