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
Who should Attend
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
This course is not scheduled at the moment but could be arranged to take place at your company location.
