THE NEXT 25 YEARS

It was perhaps more important to understand how these global experts felt about how biomanufacturing will change the industry over the next 25 years. Many see the improvements in biomanufacturing today as having a profound effect on global healthcare. Improved manufacturing will permit greater global accessibility to drugs, will dramatically reduce manufacturing costs, and will ultimately increase the overall number of biological products going into clinical trials. Thus, the changes and improvements in manufacturing operations today are being directly translated into improvements in how patients will be treated over the next quarter century.

This page and the previous page include quotes that are representative of how current trends will affect the industry during the next 25 years, according to experts.

“Higher titers are transforming the way we do and think about downstream purif ication and will continue to drive innovation in this area.”—Dr. Ajish Pot ty, development eng ineer I I I, Process Solutions, EMD Millipore

“Biotech products [will become] more affordable. Addressing the needs of the patients by producing (affordable) products for smaller segments and further optimizing and standardizing the unit operations.”—Hans Engels, president and CEO, DSM Pharmaceuticals

“The focus [will continue to be] on consolidation, and a renewed focus on designing robustness (e.g., QbD, PAT) and being able to deploy processes to all parts of the globe. This means bioprocesses will be simpler, smaller, disposable, requiring minimal utility and energy inputs, while capable of standing up to increased regulatory and quality requirements.”—Jose Manuel Otero, manager/group leader, Upstream Process Development, Merck

“The standardization and harmonization of vaccines will allow us to better evaluate the effectiveness of one product compared with a similar product produced by a different institution or a different process, allowing better choices to be made for continued production. The product produced, released, and marketed will be of a higher quality.”—Janet Lathey, director, Immunology and Assay Validation, Emergent BioSolutions

“Big changes are already happening. Now I’m looking forward to the new different, big changes! Which ones? No idea!”—Dr. Fausto Vellani, COO, Cerbios-Pharma SA

“Industrialization of antibody-drug conjugate products. I expect to see many more products in this class on the market in the next 25 years – with indication expanding well beyond traditional oncology applications.”—Anonymous, director, global bio/pharma

“The cost of human health care will decrease with increased productivities and highly efficacious products coming out of these advances. Green manufacturing will be part of new human health care with the expansion of eco-friendly disposable use.” — Semsi Ensari, associate director, Process Development, Upstream, Ambrx

“Automation and miniaturization will increase in the future.”—Eric Halioua, CEO, Promethera Biosciences

“Making smalle r manufac tur ing facilities, fewer and platformed unit operations, and making biopharmaceutical manufacturing more portable and clonable at any part of the world.”—Sourav Kundu, director, Process Development, Amgen

“More products on the market much more quickly. Hopefully, we will address the waste management of all of these “disposable” it ems. The re are opportunities for advances to be made in recycling technology as we address this issue.”—Michael Larson, downstream process development, CMC Biologics

“Better controlled commercial manufacturing processes providing more reliable and sustainable delivery of new biopharmaceuticals for the treatment of life-threatening diseases to improve patients’ lives.”—Dr. Denny Kraichely, associate director and CMC Team Leader, Port folio Management, Janssen

“Increased product titers and the worldwide adoption of process will lead to price reductions and increased access of [drug] products to the worldwide community. The changes will also lead to a wider range of products being taken forward to clinical trials.“—Tony Hitchcock, head of manufacturing technologies, Cobra Biologics

“Over the next 25 years, improved [production] economics will allow for the development of therapeutics and vaccines designed to treat more targeted and specific diseases.”— Michael LaBreck, global product manager, TangenX TFF Products, Novasep

“The higher titers are driving two fundamental changes: To smaller bioreactors and the possible use of 2000-L single-use bioreactors for full-scale production, and to transfer of the process bottleneck from upst ream to downst ream, which is driving a need for improved or new downst ream processing technologies.”— Jeffrey C. Johnson, engineering director, BioVaccine Process Engineering, Merck