There are progressing expectations for analytical methods as biopharmaceuticals progress from concept to commercialization. Methods touch on more than 40 activities including regulatory submissions, driving manufacturing decisions, product release, method transfer, comparability studies, etc. While there are certain defined regulatory expectations around biopharmaceutical methods (e.g., validated prior to filing BLA) there are also numerous areas where regulatory and industry consensus is lacking (e.g., method qualification). Method issues can impact product approval, product availability, cost of method development, and cost of production.
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.
This course is not intended to explore bio-analytical methods associated with clinical studies.
Learning Objectives:
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.
Who will Benefit:
This course is designed for people with significant roles in developing, executing, and maintaining biopharmaceutical methods. The course will cover analytical method requirements for biopharmaceuticals as well as the different strategies employed by start-up companies as well as mature biopharmaceutical companies.
This course is designed for people tasked with developing, maintaining and/or improving environmental monitoring programs for non-sterile manufacturing facilities. This includes individuals that have Quality Management Systems responsibilities for making general improvements in their organization's performance specifically related to microbial control of the manufacturing environment. Following personnel will benefit from the course:
- QC supervisors and managers
- QA supervisors and managers
- Product development business strategists
- Regulatory professionals
- Compliance professionals
- Quality engineers
- Quality auditors
- 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:
- Experimental stage
- Stage I clinicals
- Stage II clinicals
- Stage III Clinicals
- Commercial production
- 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?
- Method Qualification and Validation
- ICH requirements
- 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-related investigations
- Validation amendments and deviations
- Method validations as living documents
- Analytical Lifecycle management
- Purpose
- Requirements
- Method monitoring
- Basics of SPC
- Application of SPC
- Method Transfer
- Types of transfers
- Risk-based approach to method transfer
- Current thoughts of regulators and industry leaders
- Wrap-up and Questions
Jeff Staecker
Principal Consultant, BioPhia Consulting
Jeff Staecker has worked in GMP industries for over 25 years whose experience covers a breadth of functional responsibilities (QC, QA, R & D, manufacturing) as well as working for manufacturers, a contract testing organizations, and contract manufacturing organization. Responsibilities have included oversight of groups of more than 70 individuals, large budgets, as well as individual responsibilities such as leading risk assessments, technology transfer, and consent-decree remediation activities. Jeff has had multiple roles in method transfers for more than 20 years and recently (January 23) co-chaired and presented at an international meeting “Methods on the Move: Addressing Method Transfer Challenges for the Biopharmaceutical Industry” (http://www.casss.org/page/CMCJ1700).
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