DUBLIN–(BUSINESS WIRE)–The “Method
Development and Validation for Assays Supporting Testing of Biologics”
conference has been added to ResearchAndMarkets.com’s
offering.
Biologics continue to be a steadily growing component of the
pharmaceutical industry. The advent of large molecule therapeutics
requires a different perspective on the assays needed to support
development through preclinical and clinical testing.
This 2-day seminar is designed to offer a broad overview of developing
and validating a range of assay methodologies for biologics with
specific key analysis of cell culture, assay variability, and DOE.
Specifically, this seminar covers essential concepts related to
cell-based potency methods, ELISA, and other methods supporting
biologics. In addition to potency methods this seminar addresses
immunogenicity methods for preclinical and clinical studies. The format
of the seminar offers an examination of current best practices as well
as time to dissect examples of documentation with emphasis on beneficial
systems to consider. Scientists who attend this 2-day seminar will gain
knowledge that will be beneficial in helping to achieve well-controlled
validated methods.
Learning Objectives:
- Understanding the different requirements for small versus large
molecules - Mapping appropriate timelines with decision points
- Designing, developing, optimizing, and validating key methods
- Potency methods, other release and stability methods
- Preclinical and clinical methods
- Use of DOE and statistical analysis
- Handling of critical materials
- Process monitoring concepts
- Assessment of orthogonal methods
- Assessing readiness for validation
- Defining the validation protocol with real-time capture of data
analysis - Maintaining quality through documentation
Who Should Attend:
Below titles working in biopharmaceuticals, pharmaceuticals, natural
products/botanicals will be benefited by attending this seminar:
- Validation Scientists
- QA/QC
- Regulatory Affairs
- Laboratory Managers
- Assay Development Specialists
- Statistician
- CMC Titles
- Bio Assay
For more information about this conference visit https://ift.tt/2vcczBc
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