BioPharm International-04-15-2019

Contract manufacturing organizations need to adapt to successfully overcome the specific challenges posed by complex therapies.

The growing trend of partnerships between small biotech companies and CDMOs makes the need for conducting CMC due diligence increasingly important.

Increasingly complex monoclonal antibody molecules will require the right “tool box” for scaling up manufacturing.

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.

More manufacturers are embracing MAM, which simplifies biopharmaceutical product quality testing, and facilitates the measurement and monitoring of critical quality attributes.