Process Flexibility with Extended Reach and Cost Savings
Freezing in single-use assemblies allows pharmaceutical manufacturers to expand their reach, increase their process flexibility and efficiency, reduce their capital requirement, lower their operating costs by enabling batch processing, and ultimately serve more patients in a shorter time. Single-use systems require no cleaning and sterilization. Maintenance and validation times are reduced. Large volumes of an expensive biological drug substance can be frozen in batches to allow the drug product to be manufactured based on real-time commercial or clinical demands.
It has become common to geographically decouple global drug substance bioprocessing from final drug product manufacturing: Large amounts of the drug substance are produced at one site, and then the material is frozen into many smaller units and shipped to different sites for final drug processing. Use of integrated, single-use freeze-thaw systems composed of plastic bio-containers, bags, tubing, and connectors is now standard for the industry.
The logistics of decoupling drug substance manufacturing from final drug product formulation is now possible using integrated single-use freeze-thaw assemblies which incorporate reliable components, such as the connectors supplied by CPC.