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What to Consider when Scaling Fill/Finish for Cell & Gene Therapy?

Transitioning from lab manufacture to commercialization presents significant challenges, no matter what area you’re working in. Cell and gene therapies are no different and production quantities must scale at multiple stages, first to support clinical trials and then when they reach the market.

Evolving CMC Analytical Techniques for Biopharmaceuticals

1.0 Abstract During the (early) preclinical drug development process as well as manufacturing of biopharmaceutical (protein) products, analysis and characterization are crucial in gaining a...

When Data Integrity Takes Center Stage

1.0 Abstract Data integrity has become an important issue. To comply with regulations, companies need to optimize data integrity and the underlying strategies involved in...