Webinar: Biomarker Bioanalysis Support to the Drug Development and Personalized Medicine
WEBINAR: Outsourcing Analytical Testing for Biologics from a CRO point of view!
The advent of revolutionary technologies offers new instruments to advance analytical science. Many analytical methods are rapidly evolving. For example, high-resolution mass spectrometry enables top-down, or middle-down approaches to characterize structure and modification of the macromolecules, in addition to traditional bottom-up peptide mapping; the workflow for N-linked glycan analysis is integrated with highly active PNGase F and a novel probe for both fluorescence and mass detection, while new endoglycosidase for O-linked glycan is becoming commercially available; capillary electrophoresis is replacing traditional slab gel for SDS-PAGE, IEF and Western blotting. Advances in instrumentation for surface plasmon resonance (SPR) and bio-layer interferometry (BLI) techniques make it feasible for routine testing of receptor binding kinetics. In addition, the Solo VPE technologyenables direct and neat determination of protein concentration without the need for sample dilution and thus received rapid acceptance in the biopharmaceutical industry when it was introduced.
At the center of the field, regulatory agencies have provided specific guidelines for large molecule analytical testing. In the "Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use" document, the US Food and Drug Administration (FDA) requires that "a precise and thorough characterization of antibody structural integrity, specificity, and potency should be conducted and described in the IND." While the guidance pertained specifically to monoclonal antibody products for human use, it can be applied to all other biologics in general. In July 2017, FDA issued the guidance for "Analytical Procedures and Methods Validation for Drugs and Biologics", which complements the International Conference on Harmonisation (ICH) guidance Q2(R1), "Validation of Analytical Procedures: Text and Methodology Q2(R1)" for developing and validating analytical methods. The guidance provided general requirements for analytical procedure development and validation using statistical tools, for example, analysis of variance (ANOVA) to assess regression analysis.
In response to the demand from biopharmaceutical and biotech companies, as well as the regulatory agencies, CROs also need to modernize the analytical capabilities to support clients and solve the most challenging problems for large molecules, as well as provide service for release and stability testing. This webinar will provide the audience with a general explanation of how CROs can support biologics testing, ranging from product release and stability to in-depth structural elucidation and degradation pathway studies.
Click here for More Information: http://xtalks.com/Outsourcing-Analytical-Testing-Biologics-CRO.html
Click here to REGISTER: https://register.gotowebinar.com/register/1041119148838122243
WEBINAR: Pre-existing antibodies within clinical samples: How does this affect immunogenicity outcomes?
WEBINAR: Bioanalysis of Liposomal Drugs by LC-MS/MS
WEBINAR: Incorporation of Microsampling Techniques in Bioanalytical Assays – Dried Blood Spots (DBS) and capillary microsampling
WEBINAR: Strategies and Solutions for Early Phase Formulation Development and CTM Manufacturing
Webinar: Chinese American Chromatography Association (CACA) Webinar by Dr. Kai Wang
Webinar: Stability Testing as a Quality Control Measure: Optimizing the Process throughout the Product Lifecycle
Please register for Bioanalysis of Liposome Drugs by LC-MS/MS
When: Jan 30, 2019 12:00 PM EST
Registration link: https://attendee.gotowebinar.com/register/4471826335819394817
Speaker:Kai Wang, Ph.D.
Lab Manager, Bioanalytical Services
Frontage Labboratories, Inc.
Liposomes, used as carriers for drug delivery, are widely applied in pharmaceutical industry due to its unique capabilities such as encapsulating and protecting the therapeutic analytes from degradation, controlling release rate, facilitating on-target delivery and reducing toxicity for drugs. For liposomal drug product development, validated bioanalytical methods to determine encapsulated and free concentration of the active substance in biological samples should be employed. This webinar presents history, introduction, applications and regulatory considerations for liposomal drugs and also discusses the development and validation of LC-MS/MS methods for the quantitation of total (encapsulated plus free), encapsulated and free drug concentrations for liposome drug products.
Key Learning Objectives:
• History, Introduction, Applications & Regulatory Considerations
• Bioanalytical Challenges & Approaches
Who Should Attend:
• Bioanalytical method developers for liposome drug productsAfter registering, you will receive a confirmation email containing information about joining the webinar.