Advanced Protein Aggregation & Characterization is a course that covers topics such as:
- Principles of different methods for analysis of aggregation and particulate matter
- Complexity and diversity of protein aggregates in biopharmaceuticals
- In use compatibility studies
- Importance of formulation for the market success of biopharmaceuticals
- Studies of aggregates formation after mixing biopharmaceuticals with human plasma and human blood: Implications for in vivo toxicity and immunogenicity
- Compatibility of biopharmaceuticals with primary packaging: characterization of leachables and extractables
- Proteins, biosimilars, different vaccines (based on proteins, nanoparticles, viruses)
- Examples of biopharmaceuticals will include: peptides, small proteins, antibodies, large
- Regulatory aspects regarding aggregates and particulates
Advanced Protein Aggregation & Characterization brings together:
- Quality Control and Quality Assurance and Engineering Scientists
- Protein Formulation, Structure
- Biotherapeutics Analytical Scientists
- Product Stability Managers
- Process Science Research & Development
- CMC Heads, Lead Analysts
- Pharmacovigilance
- Regulatory Compliance
- Clinical Immunology Scientific Affairs
Advanced Protein Aggregation & Characterization will be held on 17-19 Apr 2024.