Re-processing strategies for biologicals API manufacturing processes.
During the past 10 years, the production of biotechnological products has reached large scale starting from fermentor volumes of several thousand litres. Due to this large scale production, the value of a single batch has significantly increased. Sometimes even in routine production, technical or human failures occur. Without a re-processing procedure in place, such a failed batch has to be discarded leading to a waste of raw materials, time, energy and to a waste of money. This can be avoided by a well-defined re-processing strategy. On the other hand re-processing always raises concerns regarding product quality and stability. Therefore, re-processing should be adequately validated to exclude a negative impact on the product. An example for such a validation study is discussed.
Opitz
U
U
Roche Diagnostics GmbH, Penzberg, Germany. ulrich.opitz@roche.com
D001688:Biological Products; D001709:Biotechnology / Q000191:economics / Q000379:methods* / Q000592:standards; D006801:Humans; D011786:Quality Control; D015203:Reproducibility of Results; D013678:Technology, Pharmaceutical / Q000191:economics / Q000379:methods* / Q000592:standards
D001688:Biological Products