In this roundtable from the new Q2 2022 issue of Pharma's Almanac, a distinguished panel of industry experts discusses the biggest challenge currently faced by the pharma/biopharma industry. The panel represents a diverse range of companies, including Ypso-Facto.
The biopharmaceutical industry has fostered undeniable scientific and technical progress in the last decades, placing the sector on the cutting edge of innovation. However, there is one domain that the biopharma industry has paid only minimal attention to so far: ecology. Indeed, developing and operating a biopharmaceutical process requires massive amounts of raw materials and consumables; several thousand liters of raw materials like cell culture media, buffer, and cleaning solutions, together with an impressive amount of plastics, are necessary to produce one kilogram of biopharmaceutical product. Besides being detrimental to the environment, this also raises the question of supply and the associated risks of shortages. Sustainability is thus an outstanding challenge that the biopharmaceutical industry needs to face. This will require developing greener processes — i.e., consuming fewer resources and generating less waste. This will also require reducing the number of experimental trials necessary to develop a process. Part of the solution may lie in digital initiatives along three focus areas: (i) the structuration and standardization of experimental results in order to ensure data completeness and reusability; (ii) the implementation of predictive simulation to virtually test a wide range of process conditions; and (iii) the rational evaluation and comparison of various process scenarios based on well-defined criteria to select the most appropriate options.