Outsourced Pharma Webinars

1. Expanding SPR Uses In Antibody Effector Function Determination 2/25/2020
   SPR can be implemented at early stages in screening and testing strategies in order to provide better, faster, and stronger analysis of drug candidates. In order to minimize risk and to get “true” affinity in binding analysis, we have adopted the latest innovation in surface plasmon resonance (SPR) technology, Biacore™ 8K, to develop and qualify assays for monoclonal antibodies and other therapeutic proteins to ensure all critical quality attributes are set and controlled with accuracy and precision.
2. Novel Analytics To Improve Bioprocessing And Validation Guideline Review 2/25/2020

   A thorough understanding of how the process impacts the product quality attributes is essential for decision-making. Implementation of a robust analytical control strategy with information-rich technologies has the potential to significantly improve characterization and productivity. This presentation will provide an overview of how innovative protein analysis tools have been adopted for better comparability, release testing, and impurity monitoring.

3. Insights in Pharmaceutical Manufacturing, Clinical Research and Technology 2/13/2020

   ISR conducted approximately two dozen pieces of research for syndication in 2019. This summary highlights learnings from these projects, and provides real, usable data for 2020 activities.

4. Reduce Product Variability, Control Temp Rates To Improve Cell Therapies 2/4/2020

   Reduced input variables and careful freeze/thaw cycles are critical in T cell processing. Here, experts examine how these factors influence and optimize mononuclear cell enrichment and cryopreservation.

5. Principles Of Immunogenicity Assessment Using Biacore T200 SPR System 2/4/2020

   Usually, ligand binding technologies such as ELISA are used for early immune responses, whereas SPR technology is utilized for the characterization of antibody isotypes.

6. Process Characterization: Ready For The FDA? (Webinar) 1/31/2020

   In this webinar, Greg Sears, Ph.D, Global Director, Process Characterization, Head of Manufacturing Science and Technology, Pharma Services, Biologics at Thermo Fisher Scientific, discusses process characterization basics, including information on what’s optional vs. what’s required.

7. Advanced Analytical Tools For Drug Product Development 12/23/2019

   Gain insight into analytical techniques that reveal answers during product development, with an emphasis on Raman spectroscopy, nuclear magnetic resonance (NMR) spectroscopy, and mass spectrometry (MS).

8. A Roadmap For Early Development To Commercial Manufacturing 12/23/2019

   A key hurdle for any drug development program is bringing the drug to clinical studies. In this webcast, industry experts have presented  key topics to consider when planning for scale-up of a development program. Real-life examples to illustrate issues that have resulted in ineffective technology transfers—and strategies that can be employed to overcome these issues. Watch the webinar to learn how to avoid common pitfalls in the transfer and scale-up process using an integrated approach.

9. Strategies To Develop Lipid-Based Drug Delivery Systems And Oral Dosage Forms 12/20/2019

   Liquid-filled capsules (LFC) are the primary delivery platform for oral delivery of lipid formulations which includes both softgels and liquid-filled hard capsules. Liquid-in-bottle is another avenue for delivering lipid formulations. Proper deployment of these technologies can provide formulators with effective delivery platforms during early-phase development and commercial products. In this webinar, industry experts discuss strategies to develop lipid-based drug delivery systems (LBDDS) for oral delivery. The experts share the fundamental principles, advantages and disadvantages of different dose forms for LBDDS and considerations for selecting a suitable dosage form for early phase development programs through commercialization.

10. The Next Generation ODT 12/20/2019

    Orally dissolving tablets (ODT) are designed to dissolve rapidly on contact with saliva, therefore eliminating the need to chew the tablet, swallow the intact tablet, or take the tablet with liquids. Zydis® ODT fast-dissolve formulation from Catalent is a unique, freeze-dried tablet that disperses instantly in the mouth in less than three seconds. View the webinar to get an overview of the Zydis ODT technology, including new ways to administer peptides and vaccines. The webinar also presents the highlights of the next generation ODT technology, Zydis Ultra which can provide a better solution in terms of improved taste masking, innovative functional coating and a wide range of applications from Rx to OTC.