Downstream

MS-Based Impurities Investigations in Biopharmaceutical Laboratories

This webcast features: Andrew Hanneman, Scientific Advisor, Charles River Laboratories One of the major challenges to developing successful biopharmaceutical products is understanding and characterizing potential impurities. Finding the source and magnitude of these impurities allows us to minimize and remove them during the manufacturing process to create a safe and effective drug. Development also needs to include supporting stability and forced degradation studies to ensure long-term safety and efficacy. Some impurities, such as protein degradants, host cell proteins, and various…

Lentiviral Vector Platform Generation: Increase Titer and Yield with Greater Predictability

This webcast features: Xin Xin, Group Leader, Small-Scale Upstream Process Development, and Senthil Kumar Kuppuswamy, Associate Principal Scientist, Downstream Process Development, WuXi Advanced Therapies The field of cell and gene therapies has expanded rapidly in the past several years. Lentiviral vectors have been in great demand as gene carriers in this field, especially for ex vivo gene therapies. However, large-scale lentiviral vector production still remains a significant challenge. WuXi Advanced Therapies has worked with Lentivirus since 2015 and it launched…

Improving and Intensifying Vaccine Purification By Implementing Affinity Chromatography

This webcast features: Zoltan Gulyas, Field Applications Specialist, Thermo Fisher Scientific Vaccines are well-established tools in the fight to eradicate infectious diseases. Over the past few decades, vaccine production has advanced significantly, largely by the introduction of new molecule modalities. However, these new types of vaccine candidates often require multiple chromatographic steps to obtain the desired level of purity. Developing an efficient purification process using the classical surface chemistries such as ion exchange and hydrophobic interaction requires significant amounts of…

How to Halve the Costs of Antibody Purification?

This webcast features: Romain Dabre, Senior Product Manager, Tosoh Bioscience Downstream processing is responsible for up to 80% of the entire production costs of biotherapeutics. Given the current drive to reduce manufacturing costs for biological therapeutics, streamlining downstream processing is necessary for chromatographers and process engineers. In this presentation, we showcase the benefits of using only two chromatography processes to purify monoclonal antibodies compared to the standard industrial process. Combining high-performance Protein A capturing and a single polishing step on salt-tolerant…

Best Practices for Ensuring High Virus Clearance When Using Anion Exchange Membrane Adsorbers

This webcast features: Sherri Dolan, Global Technology Consultant, Separations Marketing Group, Sartorius Stedim Biotech The risk of viral contamination is a concern for all biopharmaceuticals and vaccines derived from cell lines and can have serious implications. Contamination events can cost millions of dollars in investigation, clean-up, corrective action, and manufacturing plant downtime. Most importantly, such events pose a safety risk to the patient. To ensure the safety of biological products, regulatory agencies require manufacturing processes to have a validated current…

Configurable, Single-Use TFF Systems for Rapid Bioprocessing

This webcast features: David Serway, Global Director, Single-Use TFF Systems and ProConnex® Flow Paths, Repligen The explosive growth in biologics and gene therapies, the globalization of biomanufacturing, and the pressures to reduce capital investment and cost of goods while accelerating speed to market all point to changes in how bioprocessing systems/skids are designed, built, and operated. Future hardware, software, and consumables built on the principle of flexibility and extensive use of single-use, closed, complete, and ready-to-operate technologies will be described.…

FPLC Column Selection Considerations

This webcast features: Dan Yukon, Head of North American Sales and Global Sales of SNAP Products, Astrea Bioseparations This presentation will outline various selection criteria when considering glass fast protein liquid chromatography (FPLC) columns for low-pressure chromatography. The topics will include: pressure and volume considerations column configuration (aspect ratio) materials of construction frit type, design porosity, and mounting connection types adjustability construction accuracy packing tube design storage. There are many types and brands of columns available on the market, and…

Advantage of Antibody-Based Selectivity in the Purification of Next-Generation Biologics

The webcast features: Laurens Sierkstra, Senior Director, Business Leader Purification, Thermo Fisher Scientific Advances in biotherapeutics are generating an increasing range of complex molecules that present unique and often complex purification challenges. Affinity chromatography can serve as a platform solution for the purification of these challenging molecule modalities. An effective affinity resin can help to simplify biomolecule purification, reduce the number of purification steps, and reduce the overall cost of goods in biotherapeutic manufacturing. By taking advantage of antibody-based selectivity, camelid…

Webcast: Enabling Digital Chromatogram Review for a Faster and More Reliable Operation

This webcast features: Martin D. Jensen, Senior Engineer, FUJIFILM Diosynth Biotechnologies Chromatogram review is a monitoring method used to verify process performance in packed-bed chromatography processes. By observing key process parameters such as chromatography column outlet conductivity or UV absorbance, it is possible to identify the signs of a poorly packed column, resin degradation, or equipment malfunction. The industry standard practice relies on performing a paper-based qualitative visual comparison of chromatography profiles against a reference batch. This approach leads to a…

Predicting Viral Clearance Using a Non-Infectious MVM Surrogate in Downstream Development

This webcast features: David Cetlin, Senior Director, R&D, Cygnus Technologies As viruses can arise during the manufacture of biopharmaceuticals, regulatory agencies require viral clearance validation studies for each biopharmaceutical prior to approval. These studies are typically conducted in biosafety level (BSL)-2 facilities and require large capital and human resources. Due to these hurdles, process knowledge pertaining to viral clearance is limited during development and characterization. The use of an accurate, economical, and quantifiable non-infectious viral surrogate would enable downstream purification…