Technology Networks
In the rapidly expanding arena of biotherapeutic analysis and bioprocess development, the analysis of host cell proteins (HCP) is transitioning to a new phase. HCPs are contaminants in biotherapeutic drug preparations, often at low ppm concentration levels, and must be monitored due to stability, efficacy and immunogenicity concerns. Often, these protein impurities will be considered Critical Quality Attributes (CQA) and can contribute to an overall risk assessment for the product.
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Throughout the pharma industry, real-world evidence (RWE) is leveraged across organizations for key decision-making within a therapy’s life cycle — from R&D to new US Food and Drug Administration (FDA) drug submissions to commercial strategy operations.
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fiercepharma
Cannabadiol (CBD) products have been in news a lot recently, but what does it take to bring a CBD product to market for an unmet medical need? This webinar will discuss development considerations for CBD and other cannabis-derived products from a clinical, preclinical (pharmacology/toxicology), CMC, and regulatory perspective.
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N-Nitrosamine impurity findings in marketed formulations of rifampin have disrupted drug development. As a strong cytochrome P450 3A4 (CYP3A4) inducer, rifampin was regularly co-administered with investigational products
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