Printable Handouts

PDF

Navigable Slide Index

1. Introduction
2. Important things to monitor in clinical trials
3. Regulatory guidance
4. Good laboratory practice (GLP)
5. Some key principles of GLP
6. Good clinical practice (GCP)
7. Validation of analytical methods
8. Guidance on method validation
9. Industry bioanalytical method validation
10. Campath(R) (alemtuzumab)
11. CD52 antigen
12. Campath binding to lymphocytes
13. Killing of lymphocytes by Campath
14. Depletion of lymphocytes by Campath
15. Treatment of NHL with Campath
16. Pharmacokinetics
17. Measuring monoclonal antibodies in blood
18. Exploit the antigenic specificity
19. What do we want from an assay?
20. Choice of an antigen
21. Choice of cells
22. Choice of a detection method
23. Pharmacokinetics of Campath-1H
24. Flow cytometry assay
25. Flourescent cell analysis
26. Campath for prevention of GvHD
27. Depletion of lymphocytes by Campath
28. Campath levels in bone marrow transplant patients
29. Clearance rate in bone marrow transplant patients
30. Conclusions from BMT studies
31. Intravenous Campath for treatment of CLL
32. Relationship between CLL count and blood levels
33. Campath levels during intravenous treatment
34. Terminal levels in selected patients
35. Pharmacodynamics
36. Quantitation of minimal disease levels
37. Measurement of minimal residual disease
38. Determining the sensitivity of the method
39. Blood levels according to clinical response
40. Blood levels in responders vs. non-responders
41. Conclusions from CLL studies
42. Unwanted immunogenicity
43. Making mouse antibodies human-like
44. All antibodies are potentially immunogenic
45. Recommendations for immunoassays
46. Screening for unwanted antibodies
47. Polyclonal antibodies are all different
48. Assay formats
49. Direct ELISA
50. Bridging ELISA
51. Radio-immunoprecipitation
52. Surface plasmon resonance
53. Electro-chemi-luminescence
54. Chemistry of Electro-chemi-luminescence
55. Selection of reagents
56. Setting the assay cut-point
57. Cut-point
58. Normalization of cut point
59. Sensitivity
60. Other validation parameters to consider
61. Antiglobulin responses in transplant patients
62. Antiglobulins to Campath
63. Factors influencing antibody formation
64. Conclusions

Topics Covered

• Important things to monitor in clinical trials
• Pharmacokinetics
• Pharmacodynamics
• Unwanted immunogenicity
• Regulatory guidance
• Good laboratory practice
• Good clinical practice
• Assay validation
• Campath(R) (alemtuzumab)
• Measuring monoclonal antibodies in blood
• Quantitation of minimal disease
• Assay formats
• Antibodies provide both drugs and the means to monitor them

Links

Series:

• Monoclonal Antibodies as Therapeutic Agents

Categories:

• Immunology
• Methods

Therapeutic Areas:

• Immunology & Inflammation

Talk Citation

Publication History

• Published on October 1, 2007
• Reviewed on November 14, 2017

Financial Disclosures

• Dr. Geoffrey Hale has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.