Pharma Product Aggregation: Delivering Business Benefits Beyond Serialization

As we develop new methods to create more biologically relevant models for research in understanding disease etiology and innovating new treatment options, one of the most requested areas for educational materials is 3D cell models such as organoid and spheroid systems. Thermo Fisher Scientific is proud to present our webinar series on 3D culture & analysis, and more importantly, how you can get started, how to monitor and analyze 3D models and what to do with these once you have successfully cultured your organoid or spheroid model of interest. In this series we will specifically cover the following areas and after taking part in the presentations, hopefully you will be better equipped to answer the basic questions and feel enabled to get started using 3D culture systems.

Nanomaterial continues to be a hot topic among regulatory agencies globally. The recent ban on TiO2 (E171) as a food additive in Europe has highlighted the need to have a comprehensive understanding of the global regulatory environment related to the presence of nanoparticles in food additives and excipients.

Manufacturing has been paid dividends for many years through the use of quality tools such as statistical process control, quality function deployment, vendor audit management, hazard analysis critical control points (HACCP), value stream analysis, and other valuation methods. In the highly regulated industries that manufacture pharmaceuticals, foods, and cosmetics, the quality control ‘scientists’ have been typically known to perform sampling and testing for determining the acceptability of finished products. During the past decade, the pharmaceutical industry has seen a significant regulator-industry aligned paradigm change and an important leap into the formality of quality improvement using quality tools. The paradigm of final product testing (and the myth of ‘testing quality into products’) has been challenged by both the industry and regulators. Recent industry and regulatory support of ‘risk-based’ concepts and principles are intended to produce a ‘desired state’ of industry development and production of pharmaceuticals that have a higher level of consistency in meeting purity, safety, and efficacy than in prior history.

What does the future of your drug discovery program look like? Many industry leaders are finding themselves in uncharted waters: the science is more sophisticated than ever, producing paradigm-altering treatments. But, historically high R&D costs and low success rates has emphasized the need to identify drugs focused on translationally-relevant targets in the most cost and time efficient way.