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Biopharmaceutical Test Method, Methods from Cradle to Grave - Technical, Re...
Thu, May 18, 2017, 8:30 AM – Fri, May 19, 2017, 4:30 PM EDT
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.
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
Note: Use coupon code < NB5SQH8N > and get 10% off on registration.