The introduction of new production methods and technology has lead to significant improvements in product purity, ensuring optimal safety and enhancing the yield of plasma-derived proteins in plasma fractionation. Pall leads the way with technologies and integrated processes used in plasma fractionation. These include:
Precipitate SeparationModern plasma fractionation processes are mainly based on ethanol precipitation. The precipitates are predominantly separated using plate-and-frame filtration. The MEMBRAplan® DGM Plate and Frame Filter System with its specially developed filter plates, sets new standards for modern plasma fractionation. The system delivers high yield and is fully compliant with Good Manufacturing Practices (GMP) and regulatory requirements.
The benefits of the MEMBRAplan® DGM Plate and Frame Filter System technology enable faster processing and lower manufacturing costs. Target proteins can be captured in either precipitate of filtrate (supernatant) or both. The technology is used in combination with depth filter sheets which provide easy, fast and quantitative separation of precipitate in single-pass filtration, as well as high yield precipitate harvest.
Clarification and PrefiltrationCost reduction in subsequent steps in the 'downstream' process can be achieved by the optimizing of clarifying filtration. Our wide range of Seitz® depth filters allows a cost-effective and convenient format to achieve a good balance between filter life and downstream protection in the bulk of applications. Furthermore, specially-developed Seitz depth filters for color removal, lipid removal, PKA removal and prion removal represent very efficient purification technologies.
Protein Capture and Purification by ChromatographyChromatography has become an important technology for process improvement. Today, ion-exchange and affinity chromatography are widely used in the plasma purification process. High performance media, combined with efficient column and system operation leads to improved protein recoveries and higher product purity as well as removal of viral inactivation agents, such as solvent/detergents. Pall offers a rapidly-expanding sorbent range for high-capacity ion-exchange and mixed-mode chromatgraphy, solvent/detergent (S/D) removal sorbents, specific affinity capabilities and the additional advantages of high flow-rate membrane chromatography.
Ultrafiltration and DiafiltrationPall's Tangential Flow Filtration (TFF) membranes have long been established as a leading technology for concentration and diafiltration of plasma proteins. Continuous development of cassettes and systems for higher fluxes and repeated effective cleaning ensure that biopharmaceutical industry needs continue to be met.
Viral SafetyPall's concept of viral safety of using direct flow filtration with chromatography offers major advantages. Ultipor® VF Grade Virus Removal filter cartridges and Pegasus™ Grade LV6 Virus Removal filter cartridges are robust, reliable and well-established products, due to their ease of implementation and overall cost-efficiency due to their outstanding performance. We offer products and assistance for scale-up studies right through to full-scale adoption in both single-use or fully automated systems, in order to suit all likely process needs.
Mustang membrane adsorbers add the capability to remove viruses by chromatography in highly-efficient way. Where solvent/detergent (S/D) inactivation is used, SDR HyperD® Solvent-Detergent Removal chromatography sorbent is also used to achieve satisfactory removal of the S/D agents, without reducing protein yields.
Sterilizing Filtration and Bioburden ControlAll the way through the process - for buffer, vents and right up to final aseptic processing, Pall® filters for both gases and liquids assure the highest level of protection to our customers' processes.
Single-Use TechnologySingle-use (disposable) technology offers several significant advantages over standard reusable stainless steel systems, by reducing:
- Cross-contamination risk
- Cleaning and cleaning validation
- Capital investment
- Lead times
- The number of connections