Class highlights:

• Learn from more than 10 years of experience on many 100s of process data sets analyzed 
• Toolbox of key methods for bioprocess data analysis  
• Introduction to multivariate methods  
•  Introduction to machine learning methods
• Introduction to hybrid process modeling
•  Industrial examples for USP and DSP
• Model-based process understanding and design 
• Model-based process monitoring and control
• Transfer learning across molecules and scales 
• Digital twins

Topics to be covered include:

• Introduction to the role of formulation development in the biopharmaceutical industry
• Mechanisms for physical degradation of proteins and strategies for prevention and management 
  
• Mechanisms for chemical degradation of proteins and strategies to prevent chemical degradation in protein formulations
• Overview of analytical methods for monitoring protein structure and degradation, including analysis and management of impurities such as sub-visible and visible particles
• Biophysical characterization of proteins and its role in protein formulation development
• Global strategy for rational development of stable protein formulations
• Case studies in biopharmaceutical formulation development, including high/low concentration antibody formulations and delivery device integration to create combination products
• The role of advanced technologies in the detection and management of protein aggregation during formulation/device development and bioprocessing 
• Challenges in the development and manufacture of protein drug products, including strategies for overcoming these challenges
• Regulatory aspects of biologics formulation development, including regulatory guidance, process and product impurities, extractables and leachables, and more
• Exploration of novel excipients and how to implement these into the regulatory process
• Leveraging AI and ML to enhance formulation, stability and delivery methods
• Detection, identification, analysis, control, removal, risk assessment and regulation of impurities and Host Cell Proteins (HCPs)
• How to apply the concept of DoE and QbD in the development of protein formulations 

Topics to be covered: 

• Introduction to evolving modality and characteristics of biological products
• CMC regulations and guidelines applicable to therapeutic biologics
• Quality by design and critical quality attributes (ICH Q8-14)
• Overview of manufacturing process of biotherapeutic products
• Phase-appropriate CMC activities for IND/IMPD (eCTD 3.2.S, 3.2.P, and 3.2.A)
• Raw material, source material and cell banks
• Analytical development, qualification, validation, and lifecycle management
• Upstream and downstream process development and control strategy
• Formulation and final drug product production
• Manufacturing process design, characterization, qualification, and lifecycle management
• Reference material characterization, certification, and annual qualification
• DS/DP specifications, batch/lot release and stability, and expiry assignment
• Extended characterization and CMC comparability exercise

Who should attend? 

The course is beneficial to individuals involved in biologics drug research/development, bioprocess development, DS/DP manufacturing, analytical development, formulation development, quality control, quality assurance, CMC regulatory affairs, project management, supply chain or related functional areas.