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Biotech-based therapies and a move to single-use processes highlight recent industry changes.
Maik W. Jornitz, CEO, G-Con Manufacturing, Inc., and member of Pharmaceutical Technology’s Editorial Advisory Board, gives his insight on how the pharmaceutical industry has evolved over the years, especially with the move to personalized medicine.
PharmTech: During your 30 years working in the pharmaceutical industry, how has it evolved? What advances have been made? What were some factors that hindered advances?
Jornitz: A multitude of changes happened; from the dominance of small-molecule drug products to biotech-derived therapies and now the move into patient-based personalized medicines. These shifts also required the introduction of new process technologies, for example the conversion from re-usable stainless-steel processes to single-use process technologies. These processes will be further refined by patient-based therapies, as the volumes are much smaller and, in instances, cold sterilization methods like sterile filtration are not any longer applicable. With new processing technologies, cleanroom and facility designs shifted, and we see now smaller, standardized facility solutions, which are by far faster to deploy than the previous, often single-product lifecycle, large scale ‘monuments’.
PharmTech: How have regulations and standards advanced or hindered advances?
Jornitz: It is primarily by the motivation of the industry to initiate technology advances, and we have seen so with new treatment solutions coming from our industry. Having said this, a globally unified post-approval change approach would most definitely support technology advancement decisions, which would help our industry greatly to become more efficient and deploy the newest technologies rapidly.
PharmTech: What are the top three innovations that have changed the industry the most over the past 40 years and why?
Jornitz: [The following have changed the industry:]
PharmTech: What do you foresee for the next 10 years in pharma innovations, regulations, and/or markets?
Jornitz: We will see new patient-based therapies being more widespread introduced, and with this we will see very different process technologies and facility designs. Flexibility for multi-product, multi-purpose, and capacity scaling will become a prevalent need, but also the urge for a faster time-to-run for smaller footprint facilities. Such facilities will probably not any longer centralized systems, but deployed in-country/for country and potentially within a country on a regional level.
Maik W. Jornitz has been a member of the Pharmaceutical Technology Editorial Advisory Board since April 2016.
Vol. 41, No. 7
When referring to this article, please cite it as PharmTech, “Perspective: The Effect of Personalized Medicine,” Pharmaceutical Technology 41 (7) 2017.