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Printable Handouts
Navigable Slide Index
- Introduction
- Important things to monitor in clinical trials
- Regulatory guidance
- Good laboratory practice (GLP)
- Some key principles of GLP
- Good clinical practice (GCP)
- Validation of analytical methods
- Guidance on method validation
- Industry bioanalytical method validation
- Campath(R) (alemtuzumab)
- CD52 antigen
- Campath binding to lymphocytes
- Killing of lymphocytes by Campath
- Depletion of lymphocytes by Campath
- Treatment of NHL with Campath
- Pharmacokinetics
- Measuring monoclonal antibodies in blood
- Exploit the antigenic specificity
- What do we want from an assay?
- Choice of an antigen
- Choice of cells
- Choice of a detection method
- Pharmacokinetics of Campath-1H
- Flow cytometry assay
- Flourescent cell analysis
- Campath for prevention of GvHD
- Depletion of lymphocytes by Campath
- Campath levels in bone marrow transplant patients
- Clearance rate in bone marrow transplant patients
- Conclusions from BMT studies
- Intravenous Campath for treatment of CLL
- Relationship between CLL count and blood levels
- Campath levels during intravenous treatment
- Terminal levels in selected patients
- Pharmacodynamics
- Quantitation of minimal disease levels
- Measurement of minimal residual disease
- Determining the sensitivity of the method
- Blood levels according to clinical response
- Blood levels in responders vs. non-responders
- Conclusions from CLL studies
- Unwanted immunogenicity
- Making mouse antibodies human-like
- All antibodies are potentially immunogenic
- Recommendations for immunoassays
- Screening for unwanted antibodies
- Polyclonal antibodies are all different
- Assay formats
- Direct ELISA
- Bridging ELISA
- Radio-immunoprecipitation
- Surface plasmon resonance
- Electro-chemi-luminescence
- Chemistry of Electro-chemi-luminescence
- Selection of reagents
- Setting the assay cut-point
- Cut-point
- Normalization of cut point
- Sensitivity
- Other validation parameters to consider
- Antiglobulin responses in transplant patients
- Antiglobulins to Campath
- Factors influencing antibody formation
- 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:
Categories:
Therapeutic Areas:
Talk Citation
Hale, G. (2017, November 14). Monitoring therapy with antibodies [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved October 6, 2024, from https://doi.org/10.69645/EWAH6828.Export Citation (RIS)
Publication History
Financial Disclosures
- Dr. Geoffrey Hale has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.