BIOTECHNOLOGY
MODERNISING THERAPEUTIC CELL PRODUCTION
Science-based innovation for manufacturing high-quality cells challenges dogma and terminology
C
ell and gene therapies are dominating the world of drug development. With the promise of significant breakthroughs
in treatment of diabetes, cancer, and congenital conditions, it is no wonder that research and development is predicted to reach US$232.5 billion by 2026, up from US$186 billion in 2019, according to an Evaluate Pharma report. With so much at stake, attention is
now shifting to adopting more modern equipment and methods to consistently produce the best cells. At the core of this trend is replacing outdated legacy
32
www.scientistlive.com
manufacturing techniques where cells are exposed to air, even if meticulously filtered air, and the negative consequences of that. It is a simple sounding concept. Since the beginning, good manufacturing practices (GMP) have been based on the use of cleanrooms and isolators. However, the industry is moving toward superior alternatives that accomplish what any air environment cannot: better protection of cells from both microbial contamination and chemical toxicity, and better control of the universal critical cell process parameters - temperature, CO2
closure, another simple sounding concept. “Without closure and separation from
and O2
air, even highly filtered air, protection from microbial contamination in cleanrooms and traditional isolators is dependent on the liberal use of gaseous
. Te key is
and liquid chemical microbial biocides. However, they are toxic to the cells too,” says Randy Yerden, a cell biologist and CEO of BioSpherix, a designer and manufacturer of cell incubation, processing and production systems. In GMP you must prove they are not harming your cells, which takes tremendous effort. Even then, it is impossible since the damage is often insidious. “In addition, emerging science tells us exposure to air, even short exposures, can degrade genotypic and phenotypic integrity and contribute to variability in cell populations. It causes suboptimal transients of those three critical cell process parameters,” adds Yerden. “Yet this is the norm in cleanrooms and traditional isolators.” If cells are produced in a more
favourable environment, you get better cells, both in terms of the number and consistency of cells produced and most important their therapeutic potency. For these reasons, moving away from legacy facilities, equipment, and practices is essential for advancing cell-based therapies.
SINGLE USE TECHNOLOGY One only needs to read the industry news to see where it is headed. Take the popularity of pre-sterilised, single-use
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60
