Navigating the Biologics Wave
Contract manufacturing organizations need to adapt to successfully overcome the specific challenges posed by complex therapies.
CMC Due Diligence for Accelerated Biologic Drug Development and Manufacturing
The growing trend of partnerships between small biotech companies and CDMOs makes the need for conducting CMC due diligence increasingly important.
Complex and Customized: Manufacturing New Molecular Formats
Increasingly complex monoclonal antibody molecules will require the right “tool box” for scaling up manufacturing.
Emerging Therapies Test Existing Bioanalytical Methods
Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex therapeutic classes.
Using the Multiple Attribute Method for Process Development and Quality Control
More manufacturers are embracing MAM, which simplifies biopharmaceutical product quality testing, and facilitates the measurement and monitoring of critical quality attributes.
