SBE Special Section: Biopharmaceuticals - A Look at the Regulations | AIChE

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SBE Special Section: Biopharmaceuticals - A Look at the Regulations

SBE Special Section

What is impeding implementation of continuous processes in biopharmaceutical manufacturing? Not the regulations.

Continuous manufacturing addresses many business needs by integrating and simplifying operational trains without compromising quality assurance. Because biological products tend to be of high value and low volume, frequently with stability limitations, asset utilization and process control are vital to both commercial success and product quality. Although continuous manufacturing is an increasingly visible change in the manufacture of chemically synthesized pharmaceuticals, in the biotech sector, continuous manufacturing is more evolutionary than revolutionary.

What are the barriers?

So what are the hurdles to implementation of continuous manufacturing in bioprocessing? Integrated unit operations and control schemes require further refinement to smooth out any technical wrinkles. Capital utilization analyses, portfolio management in multiproduct plants, and cost of conversion unevenly inform process development decisions during some technical development stages.

As the biotech sector matures, there is also a renewed and increased tension between its innovation- and learning-centered culture that strives to address unmet medical needs with cutting-edge technology and its need to mitigate capital-intensive, quality-related business risks with control, constraint, and consistency. This tension need not be a barrier to the implementation of continuous manufacturing, although it may hinder the realization of continuous manufacturing’s full potential.

In addition to technical, financial, and cultural hurdles, there is a common perception that requirements for licensure under the U.S. Public Health Service Act impede the implementation of continuous manufacturing. Numerous applications of continuous manufacturing principles in the commercial...

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