Molowa David T, Mazanet Rosemary
Biotechnology Equity Research, J P Morgan Chase, New York, NY, USA.
Biotechnol Annu Rev. 2003;9:285-302. doi: 10.1016/s1387-2656(03)09008-2.
The manufacturing of protein-based biopharmaceuticals is done in bacterial or mammalian cell cultures. While bacterial cultures are inexpensive, dependable, and approved by regulatory authorities, many complex proteins cannot be manufactured this way. Complex proteins must be manufactured in mammalian cell cultures to produce active products. Mammalian cell culture capacity is limited and has slowed the delivery of necessary biopharmaceutical products to patients. The nature of the production capacity problem and future outlook are critically examined.
基于蛋白质的生物制药是在细菌或哺乳动物细胞培养物中生产的。虽然细菌培养成本低、可靠性高且获得了监管机构的批准，但许多复杂蛋白质无法通过这种方式生产。复杂蛋白质必须在哺乳动物细胞培养物中生产才能产生活性产品。哺乳动物细胞培养能力有限，这减缓了向患者提供必要生物制药产品的速度。本文对生产能力问题的本质和未来前景进行了批判性审视。
