Automation Aids Cell and Gene Therapy Production
Manufacturers face the challenge of meeting growing demand for personalized biopharmaceuticals.
Small-Scale Syringe and Vial-Filling Capability for Development of Robust Filling Processes, Smooth Tech Transfers, and to Resolve Manufacturing Issues: Summary of Key Learnings
Use of a small-scale filler can result in increased filling efficiency.
State of Producer Cell Development for Lentiviral Vector Manufacturing
Despite many development challenges, stable producer cell lines show real promise.
Exploring How CPC Progresses Green Chemistry Practices
CPC presents a green alternative to chromatography that supports sustainable operations.
Weighing the Benefits of Single-Use Consumables
Experts outline the benefits of single-use consumables relative to traditional approaches.
Considerations for Analytical Testing for E&L
Considering the differences between small- and large-molecule drug products can help determine analytical testing methods for E&L.
Drug Shortages Continue to Plague FDA and Manufacturers
Problems continue despite actions by regulators to better prevent and address drug shortages.
The Inspection Result: Warning Letters and Form 483s
FDA Warning Letters and Form 483s can offer a path to better compliance, says Siegfried Schmitt, vice president, Technical, at Parexel.
Innovation Idolatry
If we view a change opposite of one’s interest as antithetical to innovation, we risk losing sight of our ultimate goal.
Drug Pricing’s Static Changes
The debate surrounding drug pricing changes rages on.
