Archives: Seminars.

Culture Media Validation as a Tool to Reduce Non-Conformities

Culture media validation is frequently seen as something to be avoided due to the time it takes. It is not as bad as it is perceived and spending a little time getting this right will pay dividends. Sometimes the pudding is over egged. Tests done which do not make any sense and because others have… Read more »

A Process Modelling Approach to Predict Commercial Scale Tableting Performance

During the development and manufacture of commercial drug products, it is challenging to optimise formulations during early-stage formulation development to achieve maximum commercial output (tablets/year). From an operations perspective, the greater the output the better. A second challenge encountered is the ability to use studies generated on pilot scale equipment during scale-up development. As a… Read more »

Identification of Biopharmaceutical Drug Substances

The ability of protein-based therapeutics to provide highly specific, effective therapies make them suitable candidates for the treatment of chronic diseases. According to good manufacturing practice guidelines, protein therapeutics, so-called drug substances, need to be identified before manufacturing of the drug product. However, considering their complex structure, it is challenging to correctly identify therapeutic proteins… Read more »

Modelling-led Accelerated Biologic Drug Formulation at SSPC

In this presentation I will describe how at SSPC we are developing predictive modelling methods to guide experiment in developing special requirements of new, more complex active ingredients. Through the example of Trastuzumab (Herceptin®), an antibody used to treat breast cancer, I will show how rationally designed drug carrier materials can potentially improve therapeutic activity… Read more »

Industry 5.0 – Human Factors and Digital Technology

What is Industry 5.0? It places the wellbeing of the worker at the centre of the production process and uses new technologies to provide prosperity beyond jobs and growth while respecting the production limits of the planet.” – European Commission One of the less fortunate features of current life sciences manufacturing is that the procedures and processes… Read more »