Quality Risk Management Commissioning & Qualification: Key Deliverables & Lessons Learned Webinar

There are approximately 7,000 distinct rare diseases affecting 350 million people worldwide, approximately 80 percent of which are caused by faulty genes. Scientific advances such as the CRISPR/Cas9 genome-engineering system have simplified the pharmaceutical and biotech industry’s ability to develop gene therapies, especially for single gene mutation disorders. The US Food and Drug Administration (FDA) has more than 700 active Investigational New Drug Applications (INDs) for gene and cell therapies and in 2017, the FDA approved two cell-based gene therapies and it is anticipated that gene therapy will become a mainstay treatment for many rare diseases.

In this webinar, we introduce you to laboratory information management systems (LIMS) and demonstrate how this software can help you achieve regulatory compliance, quality data management throughout your product’s life cycle.

Sample preparation is an essential step for analytical chromatography, and recently biopharmaceutical analysts are discovering the need for cleaner, concentrated and targeted sample preparation methods for large molecules. This webcast will introduce how to properly clean up and isolate monoclonal antibodies (mAbs) using a high capacity paramagnetic bead solution, demonstrate how to optimize clean-up of excess labeling reagent, salts, or surfactants before N-glycans analysis, and how to utilize a multi-mode polymeric SPE for concentrating, solvent switching and sensitivity of samples.

Concentration/Ultra-filtration (CUF) membranes are used extensively in biopharmaceutical operations. A typical purification platform may incorporate two to six CUF steps though out the downstream process.