Drug Substance Integrity via Freezing and Single-Use Systems
Recently, biopharmaceutical companies have been expanding their manufacturing networks to include facilities in multiple locations. It is now a general trend to produce the drug substance at one facility and then distribute it to multiple sites where the final drug product is made. This new processing standard allows pharmaceutical manufacturers to expand their reach and increase their process flexibility and efficiency. It also helps the company reduce their capital requirement, lower their operating costs, and ultimately serve more patients in a shorter time.
However, this new manufacturing dynamic gives rise to concerns about how to package and transport the drug substance to maintain sterility and biological integrity. Temperature, humidity, light, and vibration impact packaging options. Luckily, integrated single-use freeze-thaw assemblies have quickly met the challenge and have become the primary implementation choice for achieving successful drug substance transfers.
Integrated single-use freeze-thaw assemblies with reliable component parts, such as the connectors supplied by CPC, have become the primary implementation choice for achieving successful drug substance transfers between manufacturing facilities.