March 26, 2018 Publication in Pharm. Ind. 80, No. 2 (2018)
Given today's fast-growing biopharmaceutical market, a broad portfolio of cGMP-compliant manufacturing options is available from traditional stainless-steel equipment to various disposable devices. This article focuses on benefits and drawbacks of implementing single-use equipment for manufacturing biopharmaceuticals to meet both process efficiency and regulatory guidelines.
Depending on the type of product and the client's requirements, e.g. provision of material for clinical trials, single-use facilities allow fast changeover times and a high degree of flexibility. On the other hand, CDMOs face considerable challenges associated with single-use plastics such as material integrity and solid or chemical contaminations. In addition, an effective supply chain management is required to ensure continuous availability of consumables and consistent operational quality.
Please download the full article here.
Rentschler Biopharma SE
Dr. Cora Kaiser
Senior Director Corporate Communication