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The technical aspects of bioassay strategies are essential as ever while the biotech industry launches new biologics including modified proteins, DNA, RNA and cell-based therapeutics. The focus of this session will reinforce the importance of those bioassay technical features that contribute to the successful performance of a bioassay from assay development through to the post-marketing stage. Some of the common threads intersecting bioassay applications and strategies that will be discussed during this session include bioassay design considerations, critical reagents (e.g. reference standards), data analysis approaches, and control measures used throughout the product lifecycle.
The number and diversity of biotherapeutic modalities continues to increase. These represent complex modalities such as peptide and peptide conjugates, antisense oligonucleotides, DNA- and RNA-based therapies, drug conjugates, as well as viral vector-based therapeutics…
The technical aspects of bioassay strategies are essential as ever while the biotech industry launches new biologics including modified proteins, DNA, RNA and cell-based therapeutics…
Good Regulatory Practices are internationally recognised processes, systems, tools and methods for improving the quality of regulations. As specified by WHO, GRP aims at making sure that regulations are fit for purpose and will deliver what they are set out to achieve in terms of policy objectives…
Analytics play a critical role in assuring product quality through release testing, process control, deep characterization, defining critical quality attributes, comparability and analytical similarity…