Outlining Cell Lines’ Future with Engineering Approaches
The use of bioengineering offers practical tools for the evolution of host cells.
Late-Stage Failures of Monoclonal Antibodies
The authors review some of the monoclonal antibody candidates that reached Phase III clinical trials but were discontinued at later stages.
Excipients for High-Concentration Biologics
Careful selection is essential for achieving viscosity reduction without protein destabilization.
Opportunities for Growth and Breakthroughs for Cell and Gene Therapies
CGTs offer hope for the future of treatments, but the costly manufacturing, slow turnaround time, and need for supplies hinder progress.
Considering Blow-Fill-Seal for Biologic Drugs
The continuous, aseptic fill/finish process is finding use in vaccines and biologic drugs.
Considering Purification and Separation in the Downstream Train
Emerging drug classes are giving rise to challenges in downstream processing, pushing the need for strategizing efficiencies.
Empowering Protein Characterization
Scientists can work to overcome the challenges associated with protein characterization through empowering technologies.
Selecting and Optimizing the Right Manufacturing Partner
Optimizing the use of partners for clinical trials depends on selecting the right contractor.
A Rocky Road Ahead for Commissioner Califf
Califf will face challenges that include COVID-19, opioids, and user fees.
Characterizing the Unseen Drama of Analytics
Borrowing is good, but invention is best.
The Importance of Batch Record Reviews During Audits
Auditors must have access to the batch records of the activities they are reviewing, says Siegfried Schmitt, vice president, Technical at Parexel.
Locating Logic in Pharma Manufacturing
Reducing US dependency on overseas pharma manufacturing may prove critical in navigating supply chain disruptions.
