Fully Disposable Manufacturing Concepts for Clinical and Commercial Manufacturing and Ballroom Concepts

Area of Science:

• Biopharmaceutical Manufacturing
• Chemical Engineering
• Process Technology

Background:

• Pre-sterilized disposable technologies have transformed biopharmaceutical development and production, especially in mammalian cell culture.
• Current single-use technologies (SUTs) cover most process steps, from cell expansion to drug substance formulation.
• Limitations persist in areas like quality control, standardization, and extractables and leachables (E/L) validation.

Purpose of the Study:

• To summarize the current status of SUTs across all process unit operations using a standard monoclonal antibody (mAb) process as a model.
• To comparatively analyze the advantages and disadvantages of using disposables, including quality control and E/L validation.

Main Methods:

• Review of current single-use technologies in biopharmaceutical manufacturing.
• Analysis of a standard mAb process to illustrate SUT application.
• Comparative assessment of pros and cons of disposable systems.

Main Results:

• SUTs enable faster, less expensive, and simpler plant design, start-up, and operation compared to traditional hard-piped systems.
• The adoption of SUTs facilitates lab-like operational environments and flexible manufacturing facility designs (hard-piped, hybrid, or fully single-use).
• Closed systems with disposables allow for simultaneous Good Manufacturing Practice (GMP) manufacturing of multiple products in less segregated areas.

Conclusions:

• SUTs significantly impact manufacturing facilities, offering enhanced flexibility and efficiency.
• The development of SUTs supports the establishment of biopharmaceutical production in emerging economies.
• Continued progress in SUTs is crucial for advancing biopharmaceutical manufacturing capabilities globally.