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A review of key industry shifts and promises for the future.
The biopharma industry remains a vibrant and exciting segment, partly because of the promise it holds for a better future for each of us. Much of the energy comes from the dedication of this industry's participants: from its inventors, to its managers, to its innovative suppliers.
Twenty-five years may seem like a long time, but many of the 275 industry experts represented in BioPlan's Biotechnology Industry Council have been in the field for that time span, and have dedicated their careers to meeting the challenge of helping to bring innovative products to market. Here, the experts share their opinions about what's changed over that time, and where they see the promise and opportunity for the future. These perspectives from the industry experts, are tied to trend data from BioPlan's recently released 9th Annual Report and Survey of Biopharmaceutical Manufacturing (1).
BioPlan asked the industry, represented by 275 Biotechnology Industry Council participants, to define the evolutionary changes that have occurred over the past 25 years. Although great depth and diversity of answers were obtained from this industry's senior subject matter experts, they all generally focused on the dramatic increases in productivity resulting from improved processes, higher titers, and in particular, the enabling changes that have resulted from the introduction of single-use devices.
The comments on this page are representative of survey participants regarding thoughts on the past 25 years of change in biomanufacturing.
“The transition from highly specialized processes performed within a small number of specialist companies in equally specialized facilities, to those performed on a world-wide basis in all continents, with major growth areas outside the US and EU. From a processing perspective, the significant increases in process productivities for mono-clonal antibody systems.Additionally, the adoption of single-use technologies over the past 10 years has reduced the cost and time of getting products into clinical trials."—Tony Hitchcock, head of manufacturing technologies, Cobra Biologics
“Single use equipment.”—Dr. Fausto Vellani, COO, Cerbios-Pharma SA
“The explosive increase in cell culture productivity.”—Sourav Kundu, Director, Process Development, Amgen
“The change from lack of bioreac-tor capacity to a glut of bioreactor capacity and idle facilities, due to the dramatic increase in cell cul-ture titers.” — Jeffrey C. Johnson, engineering director, BioVaccine Process Engineering, Merck
“Single use and disposable tech-nologies have allowed process economics to play a major role in system design.”—Michael LaBreck, global product man-ager, TangenX TFF Products, Novasep
“The emergence of single-use technologies.”—Bruce Rawlings, senior mar-keting manager, Allegro SUS, Pall
“The rise and fall of reusable hardware in upstream bio-processing and the takeover by disposables (both upstream and downstream). The effects on the industry have been truly profound.”—Dr. John Morrow, Jr., Newport Biotech Consultants
“Without question, it is the change in expression systems and cell substrate diver-sity….engineering, design, clonal selection, and metabolic engineering. We have witnessed multi-fold improvements in product titers, yields, and productivities, across a wide range of products (therapeutic proteins and vaccines). It was the engineering inside the cell that has been the driver in bioprocess innovation.”—Jose Manuel Otero, manager/group leader, Upstream Process Development, Merck
“The phenomenal increase in titers (mainly antibodies) with mamma-lian cell cultures.”—Dr. Ajish Potty, development engineer III, Process Solutions, EMD Millipore
“Emergence and maturation of mammalian cell culture as a product supply option. It has gone from struggling with low titers in the early days to stable cell lines producing several grams/L out of the gate!”—Anonymous, director, global bio/pharma
“Strain optimization and advances in genomics and pro-teomics made hard to produce proteins available for human use. Use of disposables reduced capital invest-ments in hard-steel.”—Semsi Ensari, associate director, Process Development, Upstream, Ambrx
“Better understanding of bioprocess requirements [result-ing from] dedicated facilities, to product dedicated process trains, to (truly) multipurpose facilities, as well as quan-tum leaps in product titers.”—Hans Engels, president and CEO, DSM Pharmaceuticals
“Increased standardization of bioassays. Validation param-eters have become more stringent. There has been movement for harmonization when the same assay is performed at multiple sites.”—Janet Lathey, director, Immunology and Assay Validation, Emergent BioSolutions
“Removal of animal-derived components from all aspects of production of biologics.”—Dr. Denny Kraichely, associate director and CMC team leader, Portfolio Management, Janssen
“Automation of manufacturing and formulation processes have completely changed the biomanufacturing arena and contributed to reducing cost and increasing yield.”—Eric Halioua, CEO, Promethera Biosciences
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.
“Disposables will continue to improve and infiltrate the market. They will become cheaper and easier to operatewith posit ive ramif icat ions for the cost of a developmental program, meaning that drug development willbecome faster and more efficient.”—Dr. John Morrow, Jr., Newport Biotech Consultants
“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 next25 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 smaller manufacturing 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 or 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 twofundamental 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
Reviewing the past 25 years, it is clear that the biopharmaceutical industry has more than survived the recent economic downturn, and 2012 is looking to be a good year again. This year, BioPlan's annual survey results show that both biopharma companies and their vendors are spending and investing more in improving R&D and bioprocessing productivity, staff, and other infrastructure. A summary of recent trends includes the following:
2. Top 1000 Global Biopharmaceutical Facilities Index, BioPlan Associates, www.top1000bio.com .