Minor P D
National Institute for Biological Standards and Control, Potters Bar Hertfordshire, UK.
Haemophilia. 2001 Jan;7(1):114-6. doi: 10.1046/j.1365-2516.2001.00467.x.
Biological medicinal products can be manufactured from a variety of sources. Recombinant products are currently produced from extremely well characterised cells grown in vitro and priori pose the lowest risk of transmitting infection. Validated production processes make a major contribution to product safety however.
生物药品可从多种来源生产。重组产品目前是由在体外生长的特性极为明确的细胞生产的,并且先验地具有最低的感染传播风险。然而,经过验证的生产工艺对产品安全做出了重大贡献。