NEW TOOLS TO ASSESS THE RISK OF MICROBIAL IMPURITIES IN THE PHARMACEUTICAL MANUFACTURING PROCESS

Large-scale Production of Biologics is susceptible to microbial contamination because many manufacturing steps occur under non-sterile conditions in aqueous systems at ambient temperature or 2-8 °C under substantially neutral pH conditions. Regardless of where in the Drug Substance (DS) manufacture (manufacture of the Active Pharmaceutical Ingredient), or Drug Product (DP) manufacture (manufacture of the Final Drug, e.g. formulated mAbs filled in vials or syringes) they occur, microbial contaminations can have a significant impact on product quality and patient safety.
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OTHER ON-DEMAND WEBINARS

Patient-Focused Drug Design

pharmtech

Incorporation of patient-focused drug design principles is increasingly becoming essential to ensure that a new drug is commercially successful and delivers the best patient outcomes. Often, patient factors and insights are not considered or discovered until the later phases of drug development when dose form, dose strength, and route of administration are already decided. There is tremendous potential benefit of equipping formulators and other scientists with patient insights earlier in the development process so that the drug product can be designed to address the specific needs of target patient populations.
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Biomarker Driven Drug Development

labroots

Dramatic responses observed with targeted agents in the ‘right’ genomic context have fueled large scale sequencing efforts to identify ‘effective’ treatments for a given patient. In order to expeditiously evaluate a targeted agent against a potential ‘driver’ genetic aberration, so-called Basket trials are conducted.
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Maximizing the Value of Your Drug Development Program

questexweb

This webinar will benefit executives at Biotech and Pharmaceutical companies interested in learning more about 505(b)(2) drug development and how to save time and money while maximizing the value of their drug development program.
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Studies of Mosquito Immunology and Plasmodium Virulence Using Imaging Flow Cytometry

Millipore Sigma

The classification of mosquito blood cells is controversial, complicated by the small size and number of cells one can obtain per mosquito, by the autofluorescent debris found in hemolymph, and the tendency of phagocytes to take up this autofluorescent debris. Much of the classification has been performed morphologically on cytospins of isolated cells. Imaging flow cytometry yields simultaneously acquired bright field, scatter, and fluorescent images of cells in suspension, enabling better resolution of rare cells from debris.
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