Dr. Gwen Wise-Blackman

Immune responses in the patient population during clinical trials or during post-market pharmacovigilance are a serious issue facing biologic therapeutics. Similarity to critical proteins in human physiology or possible interference with en ...

This webinar will address development and validation of complex cell-based methods some cell-based methods are multifaceted Will discuss the selection of the method and the cell line, correlating the method with the pharmaceutical activi ...

This training program will provide an overview of 21 CFR 111 regulatory requirements which governs how dietary supplements are manufactured and tested It will futher review the test procedures and documentation requirements to ensure reg ...

Therapeutic agents require testing for stability. Documenting the stability of the drug substance or drug product in different storage conditions is essential for setting specifications for expiry and shelf life. Understanding the possible ...

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 te ...

Cell-based methods are known for variability. Living systems introduce complexity not present in simple in vitro methods.  Responses to small changes in reagents, in analyst technique, and in the environment can have a major impact on cell-based s ...

Immune responses in the patient population during clinical trials or during post-market pharmacovigilance are a serious issue facing biologic therapeutics. Similarity to critical proteins in human physiology or possible interference with endogenou ...

Technology transfer is crucial to conveying information and knowledge between independent sites at a single company or between different workplaces. Transferring technology is frequently necessary for process development, manufacturing, and analyt ...

Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support. Unlike analytical test methods for small molecule ...

Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support. Unlike analytical test methods for small molecule ...