March 02, 2022
Cover Story
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The use of bioengineering offers practical tools for the evolution of host cells.
March 02, 2022
Special Coverage
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The authors review some of the monoclonal antibody candidates that reached Phase III clinical trials but were discontinued at later stages.
March 02, 2022
Development
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Careful selection is essential for achieving viscosity reduction without protein destabilization.
March 01, 2022
Manufacturing
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CGTs offer hope for the future of treatments, but the costly manufacturing, slow turnaround time, and need for supplies hinder progress.
March 01, 2022
Manufacturing
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The continuous, aseptic fill/finish process is finding use in vaccines and biologic drugs.
March 01, 2022
Downstream Processing
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Emerging drug classes are giving rise to challenges in downstream processing, pushing the need for strategizing efficiencies.
March 01, 2022
Analytics
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Scientists can work to overcome the challenges associated with protein characterization through empowering technologies.
March 01, 2022
Outsourcing
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Optimizing the use of partners for clinical trials depends on selecting the right contractor.
March 01, 2022
Regulatory Beat
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Califf will face challenges that include COVID-19, opioids, and user fees.
March 01, 2022
From the Editor
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Borrowing is good, but invention is best.
March 01, 2022
Ask The Expert
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Auditors must have access to the batch records of the activities they are reviewing, says Siegfried Schmitt, vice president, Technical at Parexel.
March 01, 2022
From the CEO
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Reducing US dependency on overseas pharma manufacturing may prove critical in navigating supply chain disruptions.