The biomanufacturing and biopharmaceutical industry is characterized by its precision, innovation, and life-changing potential. However, strict regulations, complex production methods, and high manufacturing costs make growth difficult for the otherwise thriving industry.
Those within the sector are driven to find ways to increase production and reduce costs while maintaining (if not exceeding) product quality. Investments in the research & development of intensified bioprocesses have highlighted continuous biomanufacturing as a possible solution, offering a more streamlined method of production.
Compared to the traditional method of batch manufacturing, continuous biomanufacturing, which is the uninterrupted process where raw materials are continuously loaded, processed, and unloaded, presents many new benefits to an industry looking to scale production. In this article, we’ll explore what those benefits are, as well as the challenges.
What are the benefits?
Continuous biomanufacturing offers a streamlined approach that promises a smaller facility footprint, reduced waste, and lower costs.
Economic benefits: Continuous biomanufacturing allows for reduced capital expenditures and smaller facilities, translating into lower overall costs and significant savings; one study found an 8.4-fold increase in output and a 24-fold increase in cost-effectiveness when using continuous biomanufacturing compared to batch manufacturing.
Enhanced product quality: Stricter controls, real-time monitoring, and the implementation of process analytical technologies (PAT) provide operators with greater control over the cellular and production environment, leading to more consistent and higher-quality products.
Environmental sustainability: A smaller required setup, minimized waste paired with proper disposal, and enhanced productivity all contribute to a greener biomanufacturing process.
Increased productivity: Continuous processes eliminate downtime between batches, maximizing output. Additionally, when using continuous biomanufacturing, antibodies cannot degrade in cell culture and aggregate, contributing to higher productivity levels.
What are the challenges?
Before the industry can truly take advantage of the potential of continuous manufacturing, there are certain challenges that must be overcome.
Regulatory clarity: Regulatory frameworks will need to be adapted to address the new implications and nuances brought on by continuous processes.
Flexibility: Given the ever-changing supply demands of products, flexibility in the manufacturing process is crucial. Continuous processes are often made to manufacture only a single product instead of adapting to different processes, limiting flexibility and demonstrating a need for increased R&D efforts.
Technical considerations: As more research is done into the process of continuous biomanufacturing, it’s crucial to continue developing robust and modular platforms that can handle a wide range of products.
The road ahead
Continuous biomanufacturing presents unique promise for the biopharmaceutical and biomanufacturing industry. By addressing regulatory concerns and developing flexible platforms, this technology could revolutionize drug production. As efforts to actively invest in R&D to overcome these challenges progress, we can expect a future where biopharmaceutical products can be produced efficiently, cost-effectively, and sustainably, ultimately benefiting patients worldwide.
Interested in hearing more about the developments being made in the biomanufacturing industry? Join us for the Biomanufacturing World Summit, taking place November 19-21 in San Diego, CA! Learn more at https://biomanworld.com/.
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Colleen Douglas
Senior Marketing Coordinator
Executive Platforms
Colleen joined the Executive Platforms team in May of 2022. She has five years of experience in event marketing, with an emphasis on copywriting and digital strategies.
Colleen has a BA Honours in Business Communications from Brock University and a Diploma in Digital Media Marketing from George Brown College.