This Validation training describes logical approaches to efficiently develop assays that will deliver quality data. The main body of the talk reviews current industry guidelines with a goal to preparing a scientific validation protocol and method. The seminar also analyzes critical validation parameters, describes common technical pitfalls between various technologies and suggests solutions
The past decade has seen a rise in the number and indications of biopharmaceutical drugs. Their unique properties and targeting potential can be exploited in many therapeutic areas. Unexpected immunogenicity from these biologicals (i.e., proteins, stem cells, therapeutic viruses, etc.) can easily derail the most potent drug by decreasing the efficacy or initiating a dangerous hypersensitivity response.
Early detection of immunogenicity reactions is a key component of a drug development program. Immunogenicity assays can be challenged by lack of human positive controls and ambiguity in choosing a meaningful cut-point.
The past decade has seen a rise in the number and indications of biopharmaceutical drugs. Their unique properties and targeting potential can be exploited in many therapeutic areas. Unexpected immunogenicity from these biologicals (i.e., proteins, stem cells, therapeutic viruses, etc.) can easily derail the most potent drug by decreasing the efficacy or initiating a dangerous hypersensitivity response.
Early detection of immunogenicity reactions is a key component of a drug development program. Immunogenicity assays can be challenged by lack of human positive controls and ambiguity in choosing a meaningful cut-point.
Areas Covered in the Seminar:
- Expectations of the GLP (GCLP) environment
- Choosing the correct technology
- Effective assay development
- Minimizing matrix effects
- Selecting the cut point
- Titration curves
- Setting specifications for the validation protocol
Who Will Benefit:
- Bioanalytical scientists
- Pharmacokinetic specialists
- Biotech R&D staff
- Clinical research associates
- Validation specialists
- Project Management
- Regulatory staff
- QA/QC
- Outsourcing Professionals
- Biopharmaceutical Consultants
Course Provider
Ana Menendez,
