Outsourced Pharma Webinars

1. Beyond Brexit: What Now For Clinical Supply Across Europe? 7/10/2020

   After 3 years of Brexit withdrawal negotiations, the UK is officially no longer a member of the European Union. Clinical sponsors with active and planned studies in the EU and UK can be reassured that the UK will remain part of the current trade arrangements, customs union and single market until the end of the transition period on December 31, 2020. This panel presentation will explore the early analysis of potential Brexit challenges that sponsors face and the strategic solutions that can support sponsors in a post-Brexit world.

2. The Art Of Recognizing Clinical Supply Risk Factors 7/10/2020

   No two studies are the same and each clinical supply project carries unique risks. Experienced supply chain managers know that certain study characteristics are often leading indicators that they can anticipate a supply project will be complex in nature. Watch the webinar to learn about aspects of the study protocol that can directly influence clinical supply strategy.

3. Biopharmaceutical Process Characterization 6/23/2020

   Laboratory scale process characterization provides in-depth process understanding and documentation of a manufacturing process needed to establish critical product and process parameters, determine proven acceptable control ranges and minimize the risk of manufacturing failures at production scale. Here we present process development and characterization strategies at Samsung Biologics required to support commercial scale manufacture of antibody therapeutics. In this webinar we will discuss approaches to demonstrate process understanding needed to develop a robust and scalable manufacturing process to support successful GMP manufacture of biologics.

4. Rapid Developability Assessment Of Early Phase Molecules 5/19/2020

   Scaling-up liquid formulations can present a number of challenges. Learn about potential formulation and filling issues when transitioning a liquid formulation from feasibility through commercialization.

5. Complex Liquid Formulations: Solutions For Scale-Up Challenges 5/19/2020

   Product development experts share insights and solutions on a variety of complex formulation issues including mixing, solubility, microfluidization, viscosity, filtration and special API handling.

6. Sources, Effects, And The Importance Of Elemental Impurities For Finished Drug Products 5/19/2020

   Elemental impurities can arise from a variety of sources, such as active pharmaceutical ingredients (API), excipients, manufacturing equipment, and primary container closure systems.  ICH Q3D recommends that manufacturers conduct a product risk assessment by identifying and assessing known and potential sources of elemental impurities.  This webinar reviews the impact of the most recent regulatory changes related to elemental impurities testing, guidance on the best routes to compliance, and an overview of the elemental impurities risk assessment process.

7. Coating: Curing Your Complex Oral Solid Dose Challenges 5/15/2020

   Pfizer CentreOne’s oral solid dose experts discuss how advances in the mathematics and engineering involved in understanding the process can tackle these challenges and ensure functional coating and drug layering continue to be a viable solution for the next generation of OSD drug products. Discover how coatings expertise could transform your OSD drug.

8. Sterile Filling Challenges For Early-Phase Product Development 4/2/2020

   Getting your product to the clinic fast is always a key driver in pharmaceutical product development. Producing it right the first time is another key driver. In this webcast, Pii will discuss options for delivering on both of these critical requirements and will talk about the challenges clients have in producing efficient and flexible sterile product filling solutions.

9. Expanding SPR Uses In Antibody Effector Function Determination 2/25/2020

   To minimize risk and to get “true” affinity in binding analysis, we've adopted the latest innovation in surface plasmon resonance technology to develop and qualify assays for mAbs and other therapeutic proteins.

10. Novel Analytics To Improve Bioprocessing And Validation Guideline Review 2/25/2020

    This presentation highlights how innovative protein analysis technologies have been adopted for better comparability, release testing, and impurity monitoring, to improve characterization and productivity.