Advanced process control and reporting are ever more important as biotech developers move to condense the time scale from drug candidate molecule to final approved product. Users seek out those systems that allow them to control process parameters (pH, Temperature, Dissolved Oxygen) with the same ease and accuracy enjoyed in the full scale production suite. System control capabilities, overall reliability, and absolute repeatability are of paramount concern for critical applications such as GMP seed train operations feeding production scale reactors, and small scale GMP production of diagnostic antibodies, vaccines, small quantities of therapeutics candidates, cell expansion and cellular therapies.
Finally, these systems are widely used for general cellular research applications, where the same productivity, system ease-of-use and robustness properties benefit work environments, and where the advanced control capabilities enhance the capacity for investigative use.
Single-Use Bioreactor Systems for Pharmaceutical Production
Pharmaceutical production facilities have become more flexible over the last few years. Single-use production systems including single-use bioreactors have been the key enabling technology to allow the flexible use of clean rooms for producing pharmaceuticals on a seasonal schedule.
To fully benefit from the advantages of single-use systems in terms of process safety and reduced validation efforts, the systems need to be easy to use for the operators and the processes be controlled by automated control systems. A tight control of the relevant process parameters and fast mixing at relatively low power input allows the ideal conditions for mammalian cells to grow fast, sustain the viability and produce high titers of the desired molecules.
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Pall Products for Bioreactors and Upstream Unit Operations
Biotech process development successes over the last two decades have led to increasing cell titers and higher cell-specific productivities, resulting in increasingly valuable production batches. Pall has created technologies that simplify upstream operations, reducing risk of contamination and process failure, and protecting the value of upstream products during production and processing.
Allegro™ Single-use Biocontainer Systems
||Single-use technology has proven itself as a viable alternative solution over stainless steel systems in upstream operations, by reducing risk of cross contamination, eliminating the time and costs of cleaning and cleaning validation, enhancing operator safety, and reducing the capital investment required for biotechnology start up operations. Learn more about the benefits of Pall Allegro Biocontainer Systems.
Kleenpak™ Sterile Connectors
||Pall Kleenpak sterile connectors are the most widely used technology for making easy, secure sterile connections of two fluid pathways in an upstream operations environment , providing operational simplicity, flexibility and maximum convenience, with maximum assurance of sterility. View more information about the benefits of using Pall Kleenpak sterile connector technology in your upstream operations.
Fluorodyne® EX Grade Filters for Media
Preparation and Bioreactor Charging Applications
||Protecting the bioreactor from bacterial and mycoplasma contamination is critical to upstream operational success. Pall Fluorodyne EX filters are designed specifically to provide superior microbial removal and high throughput filtration of high viscosity, high particle load fluids such as cell culture media. Fluorodyne EX filters feature unique hybrid construction with MachV asymmetric polyethersulfone (PES) pre-filtration layer and polyvinylidenefluoride (PVDF) sterilizing layers, Ultipleat® filter construction with laid over pleats and narrow core; providing the high capacity and high throughput filtration properties required for this critical application. Learn more about Fluorodyne EX grade filters.