SmithKline Beecham Pharmaceuticals, Biopharmaceutical Development, 709 Swedeland Road, King of Prussia, PA, 19406-0939, U.S.A.
Cytotechnology. 1998 Nov;28(1-3):139-45. doi: 10.1023/A:1008094017583.
Cell culture engineering has enabled the commercial marketing of about a dozen human therapeutic products derived from rDNA technology and numerous monoclonal antibody products as well. A variety of technologies have proven useful in bringing products to the marketplace. Comparisons of the technologies available 15 years ago are contrasted with those available today. A number of improvements in unit operations have greatly improved the robustness of the processes during the past 15 years. Further evolution of the technology is expected in several directions driven by commercial and regulatory pressures. Some problems remain for the next generation of cell culture engineers to solve.
细胞培养工程使大约十几个人用治疗产品和许多单克隆抗体产品能够通过 rDNA 技术进行商业化生产。许多技术已被证明可用于将产品推向市场。将 15 年前可用的技术与今天可用的技术进行了比较。在过去的 15 年中,许多单元操作的改进极大地提高了工艺的鲁棒性。在商业和监管压力的推动下,该技术预计将在几个方向上进一步发展。下一代细胞培养工程师仍需要解决一些问题。