Life Science Webinars

  1. Vaccines Development, Regulations And Manufacturing Part-1 3/25/2021

    This two-part webinar will focus on vaccines and an overview of their science, technology and, manufacturing processes. In Part 1, we will focus on the timelines and organizations involved, regulatory, quality and safety testing, and the different components and activities that contribute to their development including, antigens and adjuvants. The strategies and different philosophies which facilitate process optimization and scale-up, such as QbD and how the cost of a vaccine is assessed will also be studied.

  2. Accelerate Biopharma Development In The Digital Age 3/25/2021

    This webinar tackles the key COVID-19-related disruptions affecting manufacturing, data management and R&D in the lab, and how digital technology investments impact drug discovery and marketability.

  3. H1N1 Virus Purification Using Nuvia HP-Q AEX Chromatography Resin 3/24/2021

    Efficient virus recovery and impurity removal are challenges in the purification of viruses such as influenza A virus subtype H1N1. An overview of this development work of the vaccine production process using Nuvia HP-Q anion exchange chromatography resin is presented in this webinar. The focus of this work was to develop an efficient and cost-effective process while maintaining high quality and safety of the product. High purity and good overall yields were achieved with a single purification step. The purification step used here is scalable and can be adapted for large-scale production.

    Watch now.

  4. Advancements In Antibody Purification 3/24/2021

    The demand for more efficient and agile downstream purification processes for diversified therapeutic antibody pipelines requires the development of new strategies and technologies. Watch this webinar to learn from industry experts about emerging technologies and approaches for intensifying mAb purification, strategies for a diversified antibody pipeline including bispecific antibodies, fragments, and ADC, and how process development can improve process robustness, reduce risk, and speed time to market.

  5. Host Cell Protein (HCP) Immunoassays And Role Of Mass Spectrometry In Identification Of HCP Impurities In Downstream Samples 3/23/2021

    How can you better identify those host cell proteins (HCPs) that might co-purify with your drug substance (DS) and elicit an undesired immune response, interfere with drug safety and efficacy, or impact DS stability? Cygnus Technologies VP of R&D, Eric Bishop, discusses powerful orthogonal methods such as immunoaffinity chromatography and mass spectrometry that enable full understanding of those HCPs that are present in the product and could potentially impact patient safety and drug stability.

  6. Host Cell Protein Analysis By ELISA And Orthogonal Methods In Vaccine And Gene Therapy Development 3/23/2021

    Next generation recombinant vaccines and gene therapy products require clinical and commercial manufacturing of protein antigens and/or viral vectors produced using cell culture technologies. In this webinar, we discuss orthogonal Antibody Affinity Extraction (AAE™) and Mass Spectrometry (MS) methods used to assess ELISA Ab coverage to HCPs present in a process and identify process-specific HCP that may co-purify with a drug substance. Case studies of HEK 293, Sf9 and Vero cell-based processes are presented.

  7. HCP Immunoassay Qualification: Review Of Orthogonal Methods 3/23/2021

    A broadly reactive and well qualified HCP ELISA is critical for monitoring purification process consistency and final drug substance purity.  Here we present an overview of assay qualification steps and demonstrate how the orthogonal antibody affinity extraction and mass spectrometry methods assess ELISA Ab coverage to HCPs present in a given process and identify process-specific HCPs that may co-purify with a drug substance.

  8. A Quality By Design Approach To Viral Clearance: Predicting LRV Through The Use Of A Non-Infectious MVM Surrogate 3/23/2021

    To determine viral clearance efficacy of biomanufacturing steps, viruses are “spiked” into in-process solutions, processed and analyzed for reduction.  Due to the infectivity of these viruses, studies are conducted in BSL-2 facilities.  Costs and logistics limit analysis during process development.  Discussed here are results from several studies that utilized a non-infectious Mock Virus Particle (MVP) as an MVM surrogate.  The results demonstrated the value to be gained from such a QbD approach during process optimization.

  9. Regulatory Strategies For Gene Therapy Product Development 3/15/2021

    This webinar discusses the current state of regulatory issues around gene therapy product development, key challenges for manufacturing controls and other insights in navigating the path to commercialization.

  10. Developing A Scalable Upstream Bioreactor Process For Lentiviral Vector Production In Suspension 3/8/2021

    Gene therapies hold the promise to change lives. As your path to patients accelerates, how can you assure the robust process design, intensification and scalability that meets your evolving manufacturing needs? And what benefits can a templated process bring to your commercial success? Learn the answers to these questions and more in this webinar.