The pharmaceutical industry was founded on small molecule products, where active ingredients were manufactured by fine chemical companies using long-established industrial processing. That meant the final dosage forms had excellent stability profiles with a typical shelf-life between two to five years. The simple chemical structures meant that different producers’ products could be tested against specifications and proven to be equivalent and therefore interchangeable. Storage conditions, in the main, were controlled room temperature (20°C), which was relatively easy to maintain within the required +/- 5°C in pharmaceutical warehouses of the day.
Fast forward to today’s industry and the emergence of biologics—products made from living things. With the success of biologics such as monoclonal antibodies in treating certain diseases, rapid growth in this new type of drug ensued. The latest development in biologics is advanced therapy medicinal products (ATMPs).
This presentation delves into the specific supply chain and regulatory compliance challenges, and risks to patient safety, associated with biologics and ATMPs.
Hedley Rees has been running the UK-based consultancy PharmaFlow since 2005, specialising in operations and supply chain management in the biopharmaceutical industry. Hedley’s expertise is in the three phases of clinical trials (and preclinical if required) and ongoing distribution of products that have gained regulatory authorisations to market. Prior to that, he spent 16 years in senior roles in Big Pharma (Bayer) and 10 years in biotech (British Biotech, Vernalis and OSI Pharmaceuticals, now Astellas). Hedley is also a long-term advocate of paradigm shifting modernization in the biopharmaceutical industry, authoring Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics, published by Wiley, NJ in 2011. His next book for Wiley has the provisional title A Systems-Based Approach to Transforming Pharmaceutical Supply Chains: Transitioning from Patents to Patients, to be published in response to the many questions that have arisen during the C19 enigma.