5 Advances in Biopharmaceutical Manufacturing
Over the past decade, the biopharmaceutical industry has integrated single-use bioprocessing technology to accommodate the increasing demand for high-caliber, economical biopharmaceutical manufacturing. With single-use technology, bioprocessing manufacturing demands less energy and capital investment, increases productivity and eliminates the need for repeated sanitation including cleaning-in-place (CIP) and sterilization-in-place (SIP). Single-use systems are made possible with high-performance plastics. Solvay provides the biopharmaceutical industry with a broad portfolio of gamma stable, medical grade polymers with excellent mechanical properties, temperature stability, chemical inertness and chemical resistance.
Why Specialty Polymers
Solvay’s portfolio of specialty polymers for single-use technology is applied explicitly to filtration, peripherals and containment biopharmaceutical processes. Plastics like Solef® PVDF, a fluorinated semi-crystalline thermoplastic, offer excellent chemical and mechanical properties, tensile strength, chemical compatibility and scalability. These polymers can be found in membranes, membrane additives and housings, connectors, tubing, sensor housing, bioreactors and final containment bags.
Production in single-use systems is a significantly simplified and more flexible process than in traditional stainless steel manufacturing. Single-use technology allows for biopharmaceutical manufacturers to save time, energy, labor, resources and capital. Additionally, it eliminates the need for extensive cleaning validation and therefore requires substantially less power and raw materials to sterilize the equipment effectively. Beyond its exemption from repeated cleanup and sanitation, single-use technology offers easy assembly and disassembly allowing these systems to adjust to operational changes easily.
Quicker Turnaround to Market
Traditional stainless steel manufacturing can take anywhere from months to years due to lengthy sanitation processes and complex disassembly. Single-use systems allow biopharmaceutical plants to reduce assembly and market turnover time down to mere days. In addition to its elimination of cleaning validation and significantly easier assembly, single-use technology allows for small batch production, formulation of a more comprehensive portfolio of drugs and the ability to quickly adjust to the changes needed from drugs undergoing clinical trials.
Improved Sterility Assurance
One of the most significant differences between single-use systems and their stainless steel counterparts is cleaning validation. Single-use technology undergoes gamma irradiation to sterilize their materials, whereas stainless steel technology requires more time-consuming– cleaning in place (CIP) and sterilization in place (SIP). Additionally, stainless steel must repeatedly undergo this steam cleaning to prevent the risk of cross-contamination. Solvay specialty polymers are gamma irradiation compatible up to 50kGY to provide single-use technology with more easily-sterilized materials than stainless steel.
Reduced Capital Investment
Today, there exists an ever-increasing need for biopharmaceutical manufacturing solutions to minimize initial capital investments and development costs. Solvay’s broad portfolio of high-performance polymers offers strength and chemical resistance while allowing for more cost-effective solutions. Single-use systems allow for small-scale production facilities to produce smaller drug batches and ultimately reduce the company’s capital investment for startup pharmaceuticals.
Greater Energy Conservation
With the required cleaning validation and cleaning maintenance of stainless steel equipment, comes additional usage of energy consumption. In contrast, biopharmaceuticals manufactured with single-use systems undergo limited sterilization by gamma irradiation and are exempt from the excessive use of energy.
Single-use technology has contributed simplified production, easier sterilization and lower capital expenditures to biopharmaceutical manufacturing. Beyond these advancements, single-use systems are a more flexible alternative material to traditional stainless steel. Their usage of specialty polymers provides excellent chemical and mechanical properties with minimal to no risk of cross-contamination. Single-use technology eliminates the need for cleaning-in-place and sterilization-in-place. Solvay specialty polymers are gamma irradiation compatible and provide safe, reliable materials for single-use technology.