Advanced Immunogenicity

מרצה: Dr Ana Menendez

תאריך: 30 אוקטובר 2012
מיקום הקורס: כפר המכביה, רמת גן
מידע כללי
משך הפעילות: יום לימודים מלא
שעות:  09:00-17:00
עלות: 2,150 ₪ + מע"מ
נקודות זכות: 1
מק''ט: 12604
שפת הקורס: אנגלית
על הקורס

Biopharmaceutical products hold great promise in therapeutics because of their excellent targeting ability. Their clearance rate and safety profile has been shown to surpass small molecule drugs with the same target and disease population (e.g., Herceptin versus Tykerb in her2+ breast cancer). The advantages of biotherapeutics are tempered with the danger of inducing an unwanted immune response in patients. The increase of biopharmaceuticals in the market during the past decades has led to an increased awareness on how immunogenicity can make or break a drug. This course uses case studies and lectures to help the participants understand important industry and regulatory expectations that are required for a successful immunogenicity programs.

The course starts with an in-depth review of the biology leading to an immunogenic response to biopharmaceuticals. The next section provides technical advice on adapting and validating the in-vitro potency bioassay in a biological matrix to be used as a neutralization test.  The final sections discuss risk analysis and important clinical and pre-clinical case studies. The course is finished by a systematic examination of the EMEA guideline in the context of principles learned in the course

קהל היעד
  • Bioassay scientists
  • Bioanalytical scientists    
  • Validation specialists
  • Outsourcing Professionals
  • Project Management
  • Consultants
  • Regulatory staff
  • Pharmacologists
  • Immunologists
  • QA/QC
Advanced Immunogenicity
התועלת שתופק

Attendance will be beneficial to personnel directly involved in the pre-clinical and clinical evaluation of biopharmaceutical products. The course provides strategic discussions on risk evaluation and interpretation of results for clinical researchers to enhance technical parameters discussed in the basic bioassay and bioanalytics course.  Regulatory staff benefits with reviews of important guidelines from the FDA, EMA and industry panels.  Project managers and department directors gain the over-all perspective of the key role that the interaction that immunogenicity play in the biopharmaceutical development process.
The Bioassay and Bioanalytics course is a requirement to gain the full benefit from this course.

Learning Objectives:

  • Basic technologies and method validation for immunogenicity will not be covered in this course. The Bioassay and Bioanalytics course is a pre-requisite to gain a comprehensive understanding of Immunogenicity
  • Comprehend the fundamental biological causes of unwanted immunogenicity to biopharmaceuticals
  • Incorporate neutralizing antibody assays into your overall immunogenicity program
  • Appreciate the impact of immunogenicity on pharmacokinetics, efficacy, and safety
  • Develop an appropriate risk strategy for your immunogenicity program
  • Interpret current regulatory guidelines and expectations
השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס
  • Fundamentals Immunogenicity
    • Basics of the immune system
    • What is immunogenicity?
    • Breakdown of immune tolerance: self vs. non-self
    • Factors affecting the unwanted immunogenicity of therapeutic proteins
  • Development and Validation of Neutralization Method
    • Selection of the correct neutralization bioassay
    • Preparation and storage of the cell banks
    • Hands-on exercise on process charts to determine assay maintenance
    • Review of new 2011 White Paper on Neutralization Validation
    • Validation Protocol for Neutralization Methods  
  • Non-clinical and clinical consequences of immunogenicity
    • In vitro identification of potential immunogenic epitopes
    • Predictability of animal models
    • Correlation to patient safety and efficacy
  • Approach to immunogenicity risk
    • Clinical risk factors
    • Product risk factors
    • Sampling strategy based on risk
    • Risk management
  • EMEA and FDA Guidelines Review
אודות המרצה

Dr Ana Menendez

Ana T. Menendez, President, Menendez Bio-Consulting, LLC.
Dr. Menendez has over 30 years’ experience working in biopharmaceutical companies and is currently an international instructor and consultant on GMP/GLP/GCLP Bioassay Method Development and Validation.
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