Classifying Potent and Highly Potent Molecules
Determining how much containment is needed for API handling requires evaluation of multiple factors.
Designing Combination Products
API can be mixed with silicone and other polymers to create drug-delivery combination products.
CMO Roundup: Expansions for Biomanufacturing
CMOs have been active over the past year in expanding their biologics production and capabilities.
Small-Molecule Contract Services Update
This article provides a sampling of the latest investments, expansions, and acquisitions by small-molecule contract service providers.
What Ifs in the Five-Year Plan
Heightened uncertainty means CDMO executives need to play out planning scenarios.
Reducing Cleanroom Complexities and Cost
Why shouldn’t biopharmaceutical manufacturers be able to leverage standardized construction practices to improve time to market?
Lifecycle-Based Process Validation Emphasizes the Need for Continued Process Verification
A year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification.
How to Address Roadblocks During Technology Transfer: A CDMO’s Perspective
Real-life examples illustrate how to reduce the risks for each transferring partner and ensure that the development process meets regulatory requirements.
Pharmaceutical Technology, 2018 Outsourcing Resources (PDF)
Click the title above to open the Pharmaceutical Technology 2018 Outsourcing Resources in an interactive PDF format.
