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
- Improving asset utilization
- Improving quality by reducing deviations and sterility failures
- Improving yield and recoveries
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.
The range of single-use products available
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Single-use system manufacturers have been actively expanding their range of product offerings (see sidebar). As the list of
components available in disposable format increases, the vision of a single-use process train comes closer to reality. But
how simple is this technology to implement and operate? How easy is it to validate? How does it compare to the well established
conventional technology that the industry has been using for years? This is what this article sets out to examine.
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.
Figure 1. Arrival of growth media at a manufacturing site docked straight through the wall, using an aseptic transfer port.
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This plant was to be used to manufacture vaccines using the MVA-BN virus, which is the largest known DNA virus and is too
big to be sterile filtered. "Therefore, we needed aseptic production from A to Z—either using a completely closed process
or by having all open processes in a class 100 environment," says Wassard. "We chose to create both class 10,000 and class
100 areas, and to ensure an aseptic process we also aimed to minimize the number of open manipulations." The final setup is
an almost completely closed process; this design was facilitated, among other things, by extensive use of sterile single-use
bags, tubes, connectors, and aseptic zone-to-zone transfer technology (Figure 1).
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.
