Webinars

Cell Culture Media Analysis Using a Handheld Raman Analyzer with Onboard Chemometrics

This webcast features: Orville Dean Stuart, Technical Regional Sales Manager, Thermo Fisher Scientific This webinar presents the use of a handheld Raman analyzer with onboard chemometrics to verify the identify and monitor the quality and batch-to-batch variability of both dry powder chemically defined media and ready-to use liquid cell culture media. While scans of cell culture media using Thermo Scientific’s TruScan RM handheld Raman analyzer produce spectra with good Raman features, due to similar constituents and formulations, the TruTools add-on…

Investigation of Hitchhiking Impurities Removed by the 3M EMPHAZE AEX Hybrid Purifier

This webcast is hosted by: Dr. Hani El-Sabbahy, Biopharmaceutical Application Engineering Specialist, Separation and Purification Sciences Division, 3M United Kingdom PLC 3M™ Emphaze™ AEX Hybrid Purifier is an all-synthetic clarifier consisting of a high capacity Q-functional hydrogel and a 0.2 μm polyamide membrane. The open structure and high charge capacity can handle turbid feeds, resulting in soluble and insoluble contaminant removal. Using data generated by sophisticated LC-MS/MS techniques, this webinar will explore the impact of deploying the Emphaze AEX Hybrid…

Packing Rigid POROS Chromatography Resins: Efficient and Fast Method to Get Optimal Results

This webcast features: Dr. Anna Le Bris, Senior Application Specialist, Bioproduction, Thermo Fisher Scientific POROS resins are widely used in commercial bioprocesses for the purification of large molecules, in both the capture and polish steps of downstream processing. POROS chromatography resins are based on a rigid polymer, allowing them to withstand very high pressure and be mechanically and chemically stable. Because POROS is a rigid bead, it can be packed in cGMP columns with volumes up to 1000 L. POROS…

Robust Performance of OPUS® Columns Pre-Packed with CHT™ Resin

This webcast features: Fletcher Malcom, Product Line Leader – Chromatography, Repligen Ceramic hydroxyapatite (CHT™) resins are used in processes where unique selectivity is desired for purification of mAbs or recombinant proteins. Until recently, shipping columns pre-packed with CHT™ resin provided challenges due to the fragile nature of the chromatographic bed. To overcome these challenges, Repligen has developed a proprietary packing method for CHT™ resins which maintains chromatographic performance during transit. In this presentation, packing performance and shipping validation data will…

Scalable Purification Strategies for Viral Vectors and Vaccines

This webcast features: Mark A. Snyder, Ph.D., R&D Manager, Process Chromatography Applications, Bio-Rad Laboratories Large-scale downstream processing of viruses can face a range of obstacles different from those of many biotherapeutics. These challenges mostly arise from the size and complexity of the virus, which can affect product purity and recovery. Improvements of purification tools are necessary to overcome these challenges and must be engineered for easy scalability to meet manufacturing demands. Dr. Mark Snyder will discuss the difficulties when developing…

The Impact of Rapid Virus Quantification in the Development and Manufacture of Advanced Therapies

This webcast features: Antje Schickert, Product Manager, Virus Analytics, Sartorius Stedim Biotech Viral vectors, such as lenti- and adeno-associated viruses, are increasingly being used for the production of cell and gene therapies.  In-depth sample characterization and precise enumeration of total viral vectors is needed throughout the manufacturing process and particularly for the final formulation.  Learn how rapid accurate enumeration of the total virus provides timely information on titer leading to accelerated process development and increased efficiency of viral vector manufacturing.…

Automated, Closed-Loop, Inline Monitoring of CAR-T Cells in a Production Process

This webcast features: Jan Van Hauwermeiren, VP Sales and Marketing, Ovizio Imaging Systems Cell-based technology is a fundamental pillar of modern biotechnology. With the development of cell therapy products (CTPs), there is an increased need for robust and validated measurements for cell characterization to enable manufacturing control and a safe, high-quality product released to the patients. Our company has developed an inline, automated microscope that generates reliable viable cell counts (VCCs) without the need for active sampling, in real time…

Navigating Regulatory Expectations for Extractables and Leachables of Combination Products

This webcast features: Sandi Schaible, Senior Director, Analytical Chemistry and Regulatory Toxicology, WuXi AppTec The expectations for extractables and leachables of medical devices (delivery systems) are different than those of typical pharmaceutical applications such as container closure systems or single use systems. Learn about how the FDA reviews combination products and learn about testing expectations. Put these expectations to practice with a case study review complete including common pitfalls in testing. Key lessons learned: How does the FDA interact internally…

GMP Flow Cytometry: Applications, Considerations and Challenges

This webcast features: Jamie Hall, Project Manager, Center of Excellence for Biopharmaceuticals, Intertek Pharmaceutical Services Flow cytometry is a powerful technique which can be applied to all stages of the drug development pipeline including discovery, clinical development, CMC, regulatory submission and in support of production. It allows the analysis of complex mixtures of particles, from polystyrene beads to cells. Utilizing a broad spectrum of fluorescent detectors, assays can be set up to assess multiple parameters at once and ascertain otherwise…

China’s GMP Strategies: Dealing with Quality Management Issues, to Compete with the West

This webcast features: Dr. Fai Poon, President, Quacell Biotech Ltd. China’s biopharma sector faces multiple challenges in quality management, including lack of experience and talent, a rapidly changing regulatory environment, as well as cultural issues in management. In Part 3 of our series Fai Poon, President, QuaCell Biotech, Ltd., will cover China regulatory issues, a review of current challenges in biopharma quality management in China, and opportunities for progress in this field with the growing CMO platforms and the emerging…