One of the major challenges of plasmid manufacturing is cleaning validation. To avoid excess costs and time, disposable technology can decrease validation needs for both the cleaning and sterilization processes of fixed equipment systems.

Disposable materials for use in pharmaceutical manufacturing have come a long way from traditional reusable technology. From pipettes and syringes to disposable bioreactors and pre- packed purification columns, disposable single-use materials have many advantages for pharmaceutical manufacturing:

• Low startup cost
• Pre-sterilized components and assemblies
• Plug-and-play operations
• Increased flexibility in design and operation of systems
• Reduced validation time and cost
• Reduced changeover time

These advantages have stimulated the rapid adoption of disposable technology in clinical and small scale production applications. Single-use disposables, today, include flexible tubing systems with either direct aseptic connections or tubing fusing systems, process mixing containers, large scale bioprocess reactors, and sensors for the measurement of process parameters.

The advances in single-use disposable materials are making it easier for the Contract Manufacturer to meet the diverse and exacting requirements of researchers and gene based therapy companies in need of additional processing capabilities.

-Jerry B.