Benefits and challenges of continuous manufacturing in bioprocessing

Some molecules, like enzymes, degrade quickly at 37°C in fed-batch processes. However in continuous manufacturing (e.g., perfusion) faster product removal from the bioreactor is possible, thereby reducing degradation and preserving potency.

Furthermore molecules that self-associate, aggregate, or are prone to enzymatic fragmentation benefit from being removed more quickly.

Less exposure to degrading conditions improves yield and purity. Higher-quality product often means lower dosage needed in patients.

Despite its advantages, the widespread adoption of continuous manufacturing faces several challenges. One of the most pressing issues is the lack of sufficient manufacturing capacity. Even major pharmaceutical companies like AstraZeneca struggle with this, noting that if all of their late-stage pipeline products were approved, they would need four times their current manufacturing space. Compounding the issue is the limited number of contract manufacturing organizations (CMOs) capable of supporting continuous production. Smaller companies, which often rely on CMOs, are particularly constrained by this gap in capacity.

Another major barrier is the technical complexity of continuous manufacturing. It is generally more complicated than fed-batch processing, which itself is already more demanding than traditional batch methods. Many companies—especially smaller biotech firms—lack the expertise, infrastructure, or resources to explore continuous manufacturing on their own.

To overcome these hurdles, knowledge sharing and collaboration across the industry are critical. Organizations like AstraZeneca are actively participating in initiatives such as AMBIC, BioPhorum, and NIIMBL. These platforms provide opportunities to share best practices and lower the barriers to entry.

Source: https://www.bioprocessonline.com/doc/from-bpi-west-key-challenges-and-benefits-of-continuous-manufacturing-0001