AI Webinars

31. Maintaining Pharmacopeia Compliance Of Your Osmometer 6/21/2021

    GSK Senior Scientist Aashni Shah discusses the use of calibrators and controls in QC release testing and the current state of play around new software and hardware developments to aid compliance.

32. How To Manage Formulation Of High Concentration Biologics 6/7/2021

    We see a trend towards increasingly concentrated drug formulations due, for example, to the decreasing popularity of intravenous administration. This trend presents manufacturing challenges. In this presentation we discuss the challenges associated with high concentration and high viscosity monoclonal antibody formulations, how biopharma manages these challenges today and how the Jefferson Institute addresses these issues. We close the session by discussing the challenges for analytical devices in testing these formulations and how advances in osmolality testing in particular are applied to help minimize the risks.

33. Maximizing Product Titre By Strategic Control Of Osmolality In Mammalian Cell Bioprocesses 4/30/2021

    Osmolality is a key process parameter in mammalian cell bioprocesses that affects both specific cell growth and specific cell productivity. Published data shows that hyperosmolality, used in a targeted way at particular stages of the biological production process, for certain cell types, can enhance final product yield significantly. This presentation reviews the strategies that can be used to manipulate osmolality to increase production yields of monoclonal antibodies and other recombinant proteins.

34. Osmolality: A Predictor In Mammalian Cell Culture 4/30/2021

    In this presentation we explored the quality and significance of osmolality as a predictor for titer, glucose consumption, and growth-inhibitory by-products such as ammonium in mammalian cell culture. The measurements of different runs were used to establish correlations with osmolality and independent runs to test the predictive power of osmolality. Interestingly the osmolality is a good predictor for glucose, ammonium, and dissolved CO2 among others with a weaker power. The implementation of osmolality measurement and its application in bioprocessing is also discussed.

35. Upstream Applications Of Osmolality Testing In Cell & Gene Therapy Processes 4/30/2021

    This presentation focuses on the incorporation of osmolality testing into upstream applications which include media development, feeding strategies, and the minimization of aggregation.

36. The Future Of Osmolality Testing Within Cell & Gene Therapy 1/4/2021

    Learn more about our latest osmometers designed for process development while seamlessly transferring into GMP environments with advanced data management features (21 CFR Part 11) in this presentation, hosted by Kendal Studd, Applications Scientist.

37. Osmolality Testing: Providing Unique Process Control For Downstream Operations 12/27/2020

    Osmolality serves as a key orthogonal property in downstream processing. This webinar will demonstrate the value of osmolality testing as a key process parameter in buffer preparation, purification, and filtration operations.

38. 21 CFR Part 11 Compliance And Osmolality As A Process Parameter 12/26/2020

    FDA warning letters due to incomplete data in the pharma and biotech industries can be prevented by ensuring the reliability of electronic records, a process known as Compliance with Data Integrity. 

39. 8 Ways That Osmolality Testing Improves Cell And Gene Therapy Process Development And Manufacturing 12/26/2020

    Osmolality is a measure of solute concentration and an indication of the solution’s osmotic pressure (USP, EP). It provides the concentration of any solution and has several potential applications within cell and gene therapy development and manufacturing. Learn more about the role osmolality plays in viral vector stability.

40. Approaching Digital Transformation: How Biopharm Should Prepare For Validation And Compliance 12/18/2020

    As more people, systems and tools consume data, it becomes increasingly valuable because it can be translated into action to improve quality and performance while reducing costs and time to market. However, with additional systems and users comes a risk that, if not managed correctly, can compromise the integrity of data.