With recent advances in disposable bioreactor technology, more life sciences firms than ever are making the switch to disposable bioreactors for biologics manufacturing. While the term “disposable” often connotes wastefulness, bioreactors that use disposable bags instead of traditional culture vessels actually have significant advantages when it comes to resource conservation, including cost savings, environmental sustainability, and improving safety and compliance. For life sciences firms to stay competitive in today’s market, embracing disposable bioreactors for biologics manufacturing is a must. Innovative software solutions can smooth the transition and ensure that the company is maximizing the advantages of the disposable bioreactors.
Why Switch to Disposable Bioreactors?
Life sciences companies that switch from traditional to disposable bioreactors need to be ready to take full advantage of the key benefits of the technology. Some of these benefits include:
● Cost Savings
Disposable bioreactors have fewer parts than culture vessel-based bioreactors, which means fewer upfront and maintenance costs for life sciences companies. In addition, they don’t require constant cleaning and sterilization.[1. “Cell culture processes for monoclonal antibody production,” September 2010, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2958569/] This not only leads to a reduction in spending on cleaning materials, but also leaves lab personnel free to focus on advancing research goals instead of meticulously sterilizing culture vessels. In total, life sciences companies can expect about 22% savings in total operating cost when they switch to disposable bioreactors.[2. “Single-Use Technology and Modular Construction,” April 1, 2013, http://www.bioprocessintl.com/upstream-processing/upstream-single-use-technologies/single-use-technology-and-modular-construction-341774/]
● Environmental Sustainability
Even though disposable bioreactor bags are only used once, they are actually more environmentally sustainable than their traditional counterparts. On the front end, fewer parts means less material waste. In addition, because disposable bioreactor bags are thrown away after a single use instead of being cleaned, they reduce water use by about 87%. Disposable bioreactors also require less electricity input than traditional facilities, contributing to an overall energy savings of about 30%.[3. “The Environmental Impact of Disposable Technologies,” November 2, 2008, https://biopharmservices.com/wp-content/uploads/2014/04/EnvironmentImpactDisposables.pdf]
● Improved Safety and Compliance
When companies use traditional bioreactors, even a slight error in the sterilization of the culture vessel can lead to cross-contamination,[4. “Disposable Bioreactors Gaining Favor,” June 15, 2006, http://www.genengnews.com/gen-articles/disposable-bioreactors-gaining-favor/1807/] which can compromise the safety of the final product and put the company at risk for legal censure. By eliminating this step in the manufacturing process, disposable bioreactors make it easier for biologics manufacturers to guarantee the quality of their products.
The bioprocess performance monitoring capabilities of manufacturing software ensure that each of the advantages of disposable bioreactors can be fully realized. Ongoing process variability monitoring and alerts maintain the quality of the overall process so that the manufacturing gains from disposable bioreactors won’t be lost in other areas.
Making the Switch to Disposable Bioreactors
Despite the clear advantages of disposable bioreactors over traditional options, transitioning to a new manufacturing method requires bioprocess redesign for existing biologics, which has the potential to introduce bioprocess variability. In order to guarantee the quality of their products and remain in compliance with FDA regulations, life sciences firms must keep bioprocess variability to a minimum. During the redesign phase, when disposable bioreactors are first being incorporated, manufacturing software can be used to identify process parameters and operating ranges so that the new bioproduction process adheres to the same standards of excellence as the original.
At the same time, manufacturing software facilitates communication and collaboration between scientists that are involved in the manufacturing process. As the lab adopts new disposable bioreactor technology, lab members can learn from each other’s mistakes and successes. A scientist working to redesign the manufacturing for one of the company’s biologic antibodies might discover a unique way to use disposable bioreactors to improve a particular aspect of bioproduction, and software makes it easy to share this information with a colleague who is redesigning the manufacturing process for a similar product. As a result, everyone in the lab can take full advantage of disposable bioreactor technology.