4 Advancements in Biopharma Technology
As the biopharmaceutical demand grows, manufacturers are experiencing rapid growth and implementing single-use bioprocessing manufacturing based on reduced capital investment, increased productivity, and elimination of cleaning-in-place (CIP) and sterilization-in-place (SIP). Traditionally, stainless steel has been used in the biopharmaceutical industry, but many of today’s manufacturers are switching over to single-use technology for more flexible and reliable production. 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 Solvay 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.
Improved Sterility Assurance
Cleaning validation is one of the most significant differences between single-use systems and their stainless steel counterparts. 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.
Quicker Turnaround to Market
Biopharmaceutical manufacturers are responding to the global shortage of biopharmaceuticals and seeking new means to produce a greater supply of personalized medicine. Biopharmaceutical manufacturers are turning to single-use technology as a more flexible alternative to traditional stainless steel. Single-use technology is constructed to accommodate to needed operational changes easily. The flexibility of single-use systems 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.
Single-use systems require significantly less time, energy, labor, resources and capital. Additionally, the manufacturing of stainless steel requires sanitation processing that involves extensive amounts of power and raw materials, like chemicals and water. With no need for cleaning validation, single-use systems consume substantially less energy and raw materials to sterilize their equipment effectively. Concerning time, single-use systems cut down manufacturing time to a matter of weeks where traditional biopharmaceutical processing using stainless steel typically has a market turnover time anywhere from six months to two years.
One of the benefits of single-use technology is its ability to decrease capital investments and operational costs. Solvay contributes to these systems with robust, chemically inert specialty polymers that allow for more cost-effective operations. Additionally, single-use systems enable manufacturers to use small-scale production facilities for smaller drug batches that ultimately reduce the company’s capital investment costs.
Single-use systems allow for greater sterility assurance, faster biopharmaceutical production and more economical manufacturing than their traditional stainless steel counterparts. As single-use systems become more and more mainstream, there is an increasing demand for materials of the highest caliber to ensure safety and reliability. Solvay’s broad portfolio of specialty polymers offer the advanced chemical and mechanical properties needed to do so.