Below are links to various presentations and YouTube videos that you may find useful. You will learn about current views on Bioanalysis of Biotherapeutics, including bioanalysis of monoclonal antibodies, AAV based Gene Therapeutics, questions related to regulated bioanalysis, generation of critical assay reagents and more. 

Email me at gorovits.boris@gmail.com if you would like to view my slide decks or manuscripts that you do not see listed or linked on the list below. 

1. Recent posts on LinkedIn:
   Approved MAb Label statements on Immunogenicity 
   Use of Signal to Noise as a measure of the magnitude of immune response
   Critical importance of Immunogenciity Risk Assessment done early
   Tell me again Why don't we use Singlicate based analysis in LBAs?
   Themed issue on the topic of Immunogenciity of Biotherapeutics, AAPS J

2. Assessment of immunogenicity of transgene products encoded by AAV vectors

3. Fit for purpose qualification of Kit based Assays

4. Application of blood microsampling in cynomolgus monkey and demonstration of equivalent monoclonal antibody PK parameters compared to conventional sampling 2021

5. AAPS perspective on the EURL recommendation on the use of non-animal derived antibodies 

6. Application of Total Antibody anti-AAV detecting assays for Viral Gene Therapy Delivery Vectors. 2021

7. Complexity and diversity of bioanalytical support for gene therapy modalities 2021

8. Expectations for the Cell based Neutralizing Antibody development and validation.
   Presented at the Gene Therapy Immunogenicity 2020

9. Current Considerations for Immunoglobulin Isotype Characterization of Antibody Response against Biotherapeutics 2020

10. ADA assay cut point and its relation to the Assay conditions 

11. The value of Isotype characterization of ADA response to Protein based Biotherapeutics.
    Presented at the WRIB 2020 meeting

12. Immunogenicity of ATMPs

13. Immunogenicity of CAR Ts

14. Current considerations on characterization of immune response to Multi domain biotherapeutics

15. General Principles of Clinical Interpretation of Immunogenicity

16. FDA EMA Immunogenicity guidelines 

17. Recommendations for the characterization of immunogenicity response to multiple domain biotherapeutics

18. Primary and Secondary Humoral response by Maria-Dolores Vazquez-Abad 

19. Overview of Hypersensitivity Responses  by Maria-Dolores Vazquez-Abad 

20. Type 1 Hypersensitivity Response by Maria-Dolores Vazquez-Abad 

21. Type 2 Hypersensitivity Response by Maria-Dolores Vazquez-Abad 

22. Type 3 Hypersensitivity Response by Maria-Dolores Vazquez-Abad 

23. Type 4 Hypersensitivity Response by Maria-Dolores Vazquez-Abad 

24. Gene Therapy Summit Boris Gorovits