The economic challenges faced by today’s biopharmaceutical industry are well documented. Revenues are contracting due to patent expiries, generics competition and pricing pressure from payers that are demanding clearer demonstration of product value. By 2016, patent expiries in developed markets will save payers $127 billion, primarily in the US.1 Innovative new products are scarce as R&D budgets chase increasingly difficult scientific problems. For those products that successfully make it through development, the regulatory approval bar is higher than ever.
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Characterization of a biological product, which includes the determination of physicochemical properties, biological activity, immunochemical properties, purity and impurities, is necessary to establish the safety and efficacy profile of a given product (ICH Q6B). Cell culture-based potency assays are often the preferred format for determining biological activity since they measure the physiological response elicited by the product and can generate results within a relatively short period of time unlike typical animal-based assays. Cell-based potency assays are also often the only functional assays used for product release and stability programs. Other uses of cell-based assays include qualification of internal reference standards; characterization of process intermediates, formulations and degradation products; and support of changes in the product production process.
This white paper demonstrates how the Waters Regulated Bioanalysis System Solution, built upon the UNIFI Scientific Information System, meets the converging needs of investigators, analysts, managers, and QA and IT professional by uniting best-in-class sample preparation, UPLC/MS technology, software. and supports services in a single platform purpose-built for quantitative bioanalysis. It illustrates how the platform integrated into the workflow of the bioanalytical laboratory in a secure and complaint manner, and enables better decision making within the drug development lifecycle of a pharmaceutical organization and its respective partners.
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Optimizing biomanufacturing is particularly challenging because of variability and complexity associated with the sharing of finite and interdependent resources. Traditional approaches, like polling subject matter experts on the manufacturing floor or analyzing resource utilization rates, simply do not work. Worse still, the answers these approaches provide are often costly and can actually be detrimental to run rates and other critical KPIs.
This whitepaper discusses the role of scheduling in maximizing the use and operational flexibility of critical manufacturing facilities.
We invite you to download the latest Bio-G whitepaper: QbD in Biomanufacturing.
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