Biopharmaceutical Test Method, Methods from Cradle to Grave - Technical, Regulatory & Business Considerations
In this two day workshop conference you´ll learn about how analytical methods impact various activities, best practices, and needs versus nice to have items. The workshop will focus on technical aspects of methods as well as different business strategies that can be employed in developing methods. For a method strategy for a platform product such as monoclonal antibodies may defer certain method developmental activities whereas risks associated with delay method development for a novel biopharmaceutical may require more method development early during product development rather. This workshop will focus on how analytical method requirements can fit into different business strategies ranging from a one drug start-up company to a larger company developing platform methods.
Upon completing this course participants should:
Understand the purpose/need for analytical methods in manufacturing and for product release
Understand the various touch points that methods have with other activities and strategies to make those touch points more effective and efficient
Comprehend different alignment possibilities between a business strategy and method development program
Relate the impact of different method development investments to application of methods during commercialization
Understand the level of method development for different applications such as method validation for product release testing and method qualification for comparability studies
Integrate various method activities into an analytical lifecycle management system for commercial product
DAY 01(8:30 AM - 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
Introduction to analytical methods
What activities are impacted by methods?
What’s are the general product needs from methods?
Stage specific method development needs:
Stage I clinicals
Stage II clinicals
Stage III Clinicals
Use of standards, references, and archived material to connect past and present
Method development – technical perspective
How to choose appropriate analytical methods?
How should specification be established?
Application of validated methods
Use of non-validated methods or methods outside of validation parameters.
Outsourcing analytical methods
Contract Testing Organizations (CTOs) – advantages and important items to monitor and manage
Contract Manufacturing Organizations (CMOs) – advantages and important items to monitor and manage
GMP vs non-GMP and the grey area in between
Client direction of contractor -who’s ultimately responsible?
DAY 02(8:30 AM - 4:30 PM)
Method Qualification and Validation
Use of method development and qualification information
Defining intended use of a method
Method robustness – how much work should be done?
Going into method validations:
Use of outlier statistical analysis
Method validity criteria
Design of Experiment (DOE)-like design of method validations
Validation protocol – what should it look like?
Validation Report – what should it look like?
Your validation didn’t go as planned; what now?
Validation amendments and deviations
Method validations as living documents
Analytical Lifecycle management
Basics of SPC
Application of SPC
Types of transfers
Risk-based approach to method transfer
Current thoughts of regulators and industry leaders
Wrap-up and Questions