Introduction to Biotech Products for Regulatory Affairs
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Introduction to Biotech Products for Regulatory Affairs

Course Contents
- What are the biopharmaceuticals and biologicals
- Terminology and what it means
- Protein structure and the differences with small molecules
- Expression construct and cell banks
- Characterisation and heterogeneity
- Manufacturing process - fermentation and purification
- Comparability guidelines
- Analytical procedures and validation
- Impurity profile
- Pharmacuetical formulations, stability and adventious agents
- Preclinical requirements
- Immunogenicity - contributing factors
- Clinical development of biotech products
- What level of detail is needed in the IMPD in relation to the Clinical Phases

Course Duration
Single day duration
 
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Key Details
Duration1 day
 
£1,095
per delegate
 
 
Bookings Helpline: 01933 233884 (Monday to Thursday - 8:00am to 5:30pm and Friday 8:00am to 5:00pm).