Process Development and Control for New Modalities
Increasing molecular diversity is creating a need for the reinvention of process development and control strategies.
Removing Residual Impurities
A thorough knowledge of both the upstream and downstream processes is required to ensure effective removal of residual impurities in biopharmaceuticals.
Consumers Seek Sustainable Products
Pharma companies set goals and adopt more sustainable alternatives.
Improving the Fate of ADCs
Learning from early market failures, the biopharma industry has worked to improve the fate of antibody drug conjugates.
Upstream Processing: Biochemicals and Raw Materials
Experts reveal how to identify the “right” biochemical, the process of sourcing biochemicals, sourcing challenges, and what industry professionals should know about the space.
The Role of CoAs in Supplier Oversight
Industry experts discuss best practices for certificates of analysis.
Addressing the Key Pitfalls Hindering Technology Transfer Success
In this article, the potential pitfalls of technology transfers are discussed as well as ways to ensure a smooth transition.
The State of Contamination Control
Various advances in contamination control are being utilized to reduce the chance pollutants contaminate a drug product.
FDA User Fees Reauthorized
FDA keeps its user fees but fails to gain important reforms.
Conference Time Brings Gifts
Content is king in publishing, but interpretation is imperator.
Principles of Equipment Qualification
Documentation is crucial to equipment qualification, says Siegfried Schmitt, vice president, Technical at Parexel.
Voice of Regulators
Next year's "FDA Voices" series will cover core topics FDA staff are prioritizing.
