In its early days, the biotech industry was almost entirely science driven, but it has since expanded from a laboratory environment to a sophisticated and dynamic manufacturing environment. As technological discoveries are increasingly translated into commercial products, biotech companies are realizing that they must generate a stronger return on assets.
The implications of this evolution are that production costs and capacity utilization are becoming critical success factors. In general terms, the drive for operational excellence requires initiatives that improve quality, increase throughput, and reduce waste. This translates into
Biotech facilities are complex and highly regulated, and the industry is on the lookout for technologies that can simplify operations, improve product security, speed up changeovers and consequently improve quality and reduce costs. For this reason, we have seen rapid adoption of single-use technologies, particularly over the last five years. Single-use technologies can play a significant role in this drive for operational excellence by offering closed, sterile, ready-to-use systems that eliminate the risk of cross contamination and the need for cleaning and cleaning validation. This enables faster turnaround and hence higher throughput.
Project management for implementing disposables
The design and specification of process equipment and support operations typically are determined early in facility design, because these factors have a direct impact on facility architecture, utilities, air classifications, and flows of process, material, and personnel. So how do industry end-users evaluate the implementation of single-use systems for a new facility or retrofit project? Two managers with recent experience in this area give their views.
Perspective 1: Using Disposables in a New Facility
Karin Wassard, production director for Bavarian Nordic's smallpox vaccine manufacturing facility, evaluated the use of disposables for a new site.
Despite designing the process around closed systems wherever possible, Wassard decided to go for a low risk approach in construction by keeping room classifications high. This was decided due to parallel activities in closing the process and construction on site.
Bavarian Nordic worked with separate partners who handled engineering, process scale-up and optimization, and disposable systems. The final process design for the disposables implementation was carried out by Bavarian Nordic in collaboration with disposable system providers.