During the past few years, use of disposable bioreactors in development and manufacturing processes has become widely accepted. Particularly, low–oxygen-demanding cell types such as human and insect cells have proven to be perfectly suitable for cultivation in single-use bag chambers. These bioreactors have significant advantages over their reusable counterparts (
1
). They transform a single-purpose process using stainless steel reactors into a multipurpose facility in which switching from one application to another is both easy and cost effective.
Reusable stainless steel bioreactors have fixed vessel configurations with predefined port assemblies, whereas single-use bioreactors use presterilized plastic cultivation chambers that get discarded after use. That makes adapting such cultivation vessels to specific applications highly convenient. Because single-use bags are presterilized by their suppliers, sterilization/cleaning is not required. That eliminates space-consuming and expensive clean-in-place (...
+3Disposable technology for bioprocessing is efficient and cost effective in many product development scenarios. For an industry dedicated to improving human health, however, the environmental contributions of a product must also influence its bottom line. Product transitions evaluated within a people/planet/profit framework require assessment regarding shifts in human and environmental impact. Life-cycle assessment (LCA) offers one perspective by evaluating the environmental loading of inputs and outputs to a product or process. The contribution of individual product life-cycle stages to a total environmental load can be used to inform design of next-generation disposable products and optimize process development when a clear economic preference is not apparent.
Framework:
Disposables are a flexible alternative to conventional bioprocessing equipment for unit operations in which rapid development, space constraints, overhead costs, or maintenance capacity limit the applicability of stainless steel systems...
S
ingle-use technologies are becoming more widely accepted by biopharmaceutical manufacturers than ever before. The market is complex, fast-growing, and dynamic, which means integrated innovative technologies are the key to keeping pace with biopharmaceutical manufacturing needs. In fact, end users are already beginning to move away from singular disposable components to increasingly require suppliers to provide integrated solutions for specific process needs. So it is critical for suppliers to work closely with their customers and provide novel solutions.
Why the Switch?
Biopharmaceutical manufacturers are confronting the challenge of commercializing their new biological drugs faster and at lower cost than before. To meet those goals, many strive to develop more efficient processes. Single-use technologies present a sound solution.
Switching over to single-use technologies doesn’t require the “hard sell” that it used to because the benefits of such technologies have become evident. According to BioPlan A...
Many biotechnology companies recognize the powerful benefits of increasing product titer early in product development as a strategy to minimize manufacturing costs, scale, and the duration necessary to produce clinical supplies and achieve product commercialization. Additional benefits include minimizing or completely avoiding significant regulatory delays to market that can be caused by major process technology changes (such as cell line and product quality changes).
Recently, another significant benefit has been realized too: Smaller, more productive and efficient 2,000-L single-use bioreactors and purification systems can meet market demands if enough improvement is achieved in manufacturing productivity early on. These systems eliminate the enormous expense, duration, and risk of building large-scale stainless steel manufacturing plants.
Improvements achieved in scaled-down robotic high-throughput screening technologies can at best simulate large-scale performance but not guarantee it. However, succes...
+7 Most people in the biopharmaceutical industry recognize, at least anecdotally, that the use of disposables in biomanufacturing is moving forward. At BioPlan Associates, we’ve tried to quantify how things are advancing and capture some of the shifts in attitudes, especially in light of current economic challenges. The major shift is that decisions are being made more from an operational point of view. It’s become less a question of
if
disposables will be implemented than of
where
and
how.
Our newest industry study shows that concerns over adoption are rapidly becoming less strategic and more operational and commercial (
1
). As the “Methodology” box explains, this year’s study elicited data on 10 critical areas associated with biopharmaceutical production (disposables being one of these) from 443 production executives at drug developers and CMOs in 39 countries.
This year, decision makers’ objections to disposables have declined both in quantity and importance. For example, we asked respondents about...
