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    The Role of BPOG Extractables Data in the Effective Adoption of Single-Use Systems

    In recent years, pharmaceuticals have become more complex, progressing from primarily small molecule drugs to an increasing array of recombinant proteins, monoclonal antibodies and cell and gene therapies. This has led to necessary changes in regulations to accommodate new, more complex manufacturing processes that have more steps and are more sensitive to variability and contamination. …. Read the full white paper