INSIGHTS ON REGULATORY COMPLIANCE

  • Putting The “Process” Into Process Characterization

    Done correctly, Process Characterization reduces the risk of manufacturing failures and regulatory delays. Scientists at the AbbVie Bioresearch Center (ABC) have established a platform approach to Process Characterization that has been proven effective as it has been used to support the approval of several marketed products.

  • Collaboration In Biopharma: Harness Cloud-based Technologies

    Although biopharma has been slower than some other industries to adopt cloud-based technologies, the field is increasingly relying on the cloud to advance scientific knowledge.

  • How To Avoid Last Minute CMC Roadblocks To Approval

    Problems can arise when sponsors face balancing available budget and time resources between clinical and chemistry, manufacturing, and controls (CMC) needs. Because of their high-profile importance in development, clinical needs get the emphasis, while the many CMC needs and risks may seem less critical. This is a brief overview of the CMC information required by regulatory authorities and highlights why planning and budgeting for key CMC considerations early in the development process are essential for success.

  • Using A CMO To Streamline Process Characterization

    While traditional small molecule drug products usually consist of pure chemical substances that are easily analyzed after manufacture, biologics such as monoclonal antibodies (mAbs) are much more complex. 

REGULATORY COMPLIANCE SOLUTIONS