Conference:Modern Biopharmaceutical Manufacturing

[b]Dates: 6th and 7th December 2011,Bordeaux, France

PDA conference[/b]

Practical Approaches for the challenges in development and manufacturing of biopharmaceutical and biotechnological derived products in the current GMP environment will be discussed. The conference will start with a keynote presentation describing the contributions of basic science to product development and commercialization of new and innovative pharmaceuticals.

The agenda is based on four key topics:

Quality & Regulatory Update
ICH Q11 and impact on biopharmaceuticals
Industry perspective on the ICH regulations
Recent developments on bio regulations at the EMA

Single-Use-Technologies and Integration in the Manufacturing Process
Extractables & leachables in process and storage containers
Testing strategies
Case studies

Process Development and Validation − Starting with QbD
The application of QbD and its practical quality
Design of experiments, critical quality attributes, critical process parameters, risk analysis, PAT
Comparability & Tools to identify the link between critical quality attributes and biological activities
Risk based approach and regulatory compliance

Process Development and Validation − Continuous Verification
From process validation to continuous verification
Examples for process steps: Antibody purification, cleaning validation
Economic aspects considering lean approaches