The biopharmaceutical industry has started to look more seriously, in the past five years, at the potential that single-use technology offers for commercial manufacturing of biologic drug substances. There are major advantages to be had by the introduction of these technologies, none more so that the reduction in turnaround time for the manufacture of biological drug substances, leading to reduction of product costs.
Other tangible opportunities afforded by these technologies include reduced footprint of facility and energy reduction costs (i.e., reduction in sterilize-in-place [SIP] and clean-in-place [CIP] requirements and water usage). These opportunities have been well documented by various independent engineering and consultant firms. In addition, there are useful software models available to calculate what these opportunities provide from a cost perspective (1, 2).
Despite the reduced operating costs, companies are still hesitant to adopt single-use technologies, in part because of concerns that have been raised over the control of the raw materials used in the production of single-use components and finished products as well as the cost of qualification activities. Implementing oversight on the manufacturing of single-use technologies through the use of quality management systems (QMS) on the supply chain can significantly reduce the overall risk to the product.Once better manufacturing controls have been introduced to minimize leachable and extractable impact on drug products, the qualification concerns may be mitigated by integrating risk-assessment principles into the qualification of single-use systems and components.
While control and management of the supply chain could be quite unwieldy, risk assessment can be performed to limit the qualification activities needed for disposable components. This article suggests techniques for mitigating risk and securing the supply chain for single-use components used for biopharmaceutical manufacturing and using the risk assessment to reduce the cost of their associated qualification activities.