Novel viral therapies are emerging and gaining more interest after recent regulatory approval of CAR-T and AAV based gene therapies. While no viral contamination has been reported so far for these therapies, it is important to learn from historical experience and leverage improved manufacturing and testing methods to increase their safety. This would help avoid product supply and patient treatment disruptions as well as protect the company’s business and reputation. In this webinar we will highlight the biosafety challenges associated with the manufacture of viral vectors and how a holistic risk mitigation approach can reduce contamination events.
Outsourcing or implementing a streamlined buffer preparation and management systems allows biomanufacturers to considerably reduce floor usage, labor and costs. In this webinar, we will explore the benefits of an Integrated Buffer Delivery Platform.
Within the biopharmaceutical industry, there is a significant shift toward higher productivity processes resulting in improved economics without compromising robustness. Therefore, integrated continuous production technologies are of greatest interest.
Time to experiment, time to clinic, and time to market is becoming even more important for developers and manufacturers of biopharmaceuticals. At the same time, the amount of data enclosed in biologic license applications are more comprehensive to avoid extended review. In this webinar we will review three fields that enable reduced timelines and improved outcomes of process development activities.
This webinar details best practices and guidelines for packing CHT Ceramic Hydroxyapatite Media at process scale. CHT is an easy-to-use mixed-mode chromatography media which offers cation exchange and affinity interactions. Unlike other chromatography media, CHT is both the ligand and the support matrix, and is used for the purification of numerous types of biomolecules. It is considered the gold standard for aggregate removal.
Ceramic Hydroxyapatite XT, is a calcium affinity cation exchange chromatography media. It is used for the purification of numerous types of biomolecules and provides single-step clearance of impurities and aggregates for monoclonal antibody purification. CHT XT is an easy-to-use mixed-mode chromatography media. Unlike other chromatography media it is both the ligand and the support matrix.
Dr. Xuemei He introduces the features of Nuvia aPrime 4A resin that has been optimized to facilitate selective and reversible binding of molecules for high purity and recovery over traditional chromatography resins. Case studies demonstrate the purification of biomolecules with acidic and basic isolectric points and highlight these advantages.
Nuvia HP-Q is our newest strong anion exchange resin. It provides both high binding capacity and high recovery, even at high flow rates. A rigid bead with large pores and optimized surface extenders, this resin was designed for large biomolecule purification. Dr. Jiali Liao will present case studies and design features to meet manufacturing demands.
This presentation addresses product characterization strategies to de-risk the manufacturing of mAbs and cell and gene therapies. It also covers detection and characterization of host cell proteins (a factor in mAb therapies and cell and gene therapies), and polyethylenimine used in cell and gene therapies.
This webinar discusses how the unique properties of gelatin have been used to develop chewable softgel formulations for the pediatric and geriatric patient populations.
|
|
|
|
|
|
|
|
|