This paper has been written to address the compliance challenges of RTRT and the continued compliance with GMP standards. To evaluate these challenges, we have reviewed the current quality guidelines that apply to RTRT and considered the areas and activities that will be impacted by an RTRT process.
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A BioPhorum member only survey to help gain further insight around how the industry is approaching scaling the production of AAV in suspension HEK- 293 cells from lab to commercial scale.
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Media fingerprinting of cell culture media a standardized analytical test method suite and three-tier approach
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A BioPhorum member survey to gather preliminary information from across the biopharmaceutical industry on the characterization and risk assessment of HCP using mass spectrometry.
A BioPhorum member only survey to share knowledge into how, why and when enzymatic activity assays are performed.