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).
LANDMARK ADVANCES
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 PAST 25 YEARS
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
