Product Robustness: A Comprehensive Product Quality Strategy

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By Dafni Bika

Dafni Bika-finalA key challenge of manufacturing is variability. Variability is caused by many operational and human factors including human error, environment, wear and tear, variability in raw materials and active ingredients, and unclear procedures. It could also result from product and process design, for example, due to insufficient raw material controls and poorly defined processes. Lack of knowledge and risk understanding could also lead to unacceptable residual risks. Through the product life cycle, these risks may compromise the ability to supply the market and add significantly to operating costs. Historically, the pharmaceutical industry has responded by correcting and resolving issues of variability rather than focusing on systems designed to prevent these issues before they happen. This article describes a preventive and holistic strategy to reduce variability and ensure product quality and supply, which started several years ago as a remediation project for legacy products. Continue reading

Fifty Shades of Cancer Immunostimulation, Part 4: Double the Pleasure—Monoclonal Antibodies and Cytokines

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BY ROBERT G. BELL

Robert BellWe continue our discussions with two of the heavyweights of cancer immunotherapies, monoclonal antibodies and cytokines. Monoclonal antibodies (MAbs) for cancer therapies are bioengineered antibodies that are constructed to bind to specific antigens that are expressed on the surface of cancer cells. MAbs are usually made by injecting animals with human antigens. The antibodies produced are then harvested and fused with a myeloma cell (cancerous B cell) to produce a fusion cell known as a hybridoma (each hybridoma divides to produce identical daughter cells or clones [monoclonal]). Continue reading

Precision, Precision, Precision

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By Mark E. Arnold

Arnold-final2Precision is used in the current world of biomarkers in at least two ways: the precision of the assay for the biomarker, and in relation to the ability of the biomarker to be used within precision medicine, targeting the patients that will benefit from the drug. In the real world, one cannot have a precision medicine biomarker without understanding the precision of the biomarker assay. Assay precision must be evaluated as within-run (repeatability), between-run (intermediate), and between labs (reproducibility). Continue reading

AAPS Pharmaceutical Science Roundup, July 2015

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tenmplate for set 6This month’s roundup features stories on the price of cancer drugs, Alzheimer drugs treating other diseases, biohackers producing homemade insulin, effects of pharmaceutical products on wildlife, pharmacy majors marrying pharmacy majors, and more! Continue reading

Accelerating Bench-to-Bedside Translation of Nanotechnology-Based Therapies for Cancer

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By Mahavir Chougule and Chalet Tan

Mahavir ChouguleCOPHS News_FINAL.inddConventional drug therapy, such as chemotherapy, has been well recognized and has achieved modest success in the clinical treatment of cancer. However, because of the lack of specific targeting strategy, these therapies are usually accompanied by severe side effects that compromise the quality of patients’ lives. Nanotechnology-based therapies are able to achieve targeted delivery of therapeutic agents to tumors and have demonstrated great promise in revolutionizing cancer medicine by improving efficacy while reducing the adverse effects. Continue reading

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