This presentation discusses the basic definitions of extractables and leachables and why it is important to reference the vast amount of reference material available to ensure that you are meeting industry standards. Understand the role of the supply chain, what departments/positions within your company need to be involved, as well as many other factors to consider such as the machine, drug substance, material, water, and container closure system environment when designing your extractable/leachable study.
This presentation discusses some basics of cell-based assay and why it's the preferred method to support potency analysis for bio therapeutic drugs; developing and optimizing cell-based potency assay; understanding phase appropriate method validation as well as an overview of the typical workflow to transfer cell-based potency assay into a GMP environment and best practices to maintain the long term performance of the assay.
Using workflow based software solutions to guide scientists through various processes in low to high throughput screening campaigns.
This webinar explores use cases showing how machine learning and analytics can help overcome the challenges facing the biopharma industry through more confident data-driven decisions.
Striving to bring the way we acquire, share and gain insights from scientific data, through a community and the framework for standardization and linked data.
Very few new molecular entities in active clinical development are readily bioavailable, and when dosed at escalated levels, even these may not be sufficiently absorbed.
With transformational changes in biologics, there are increasingly newer formats of new biologic drugs including bispecific antibodies, antibody drug conjugates and antibody-peptide fusion proteins.
The complex structure of Biologics, the nature of the interactions with their partners, require accurate modelling method to predict their physicochemical properties.
Chesapeake IRB and CRF Health team up for a collaborative webinar to discuss informed consent oversight and visibility and why Top Pharma is turning to Electronic Informed Consent (eConsent) to exceed in these areas.
The burden of ineffective and inefficient body maps creates risks that can impact data quality. We knew we could come up with something much better - for all stakeholders.
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