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BioPharm International-08-01-2020
BioPharm International
Chromatographic Science Clarifies Separation Challenges
August 02, 2020
Cover Story
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New therapeutics modalities and the need for greater process efficiency are driving technology development.
The Impact of SARS-CoV-2 on Biomanufacturing Operations
August 02, 2020
Quality/Regulations
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This article presents the results of a survey conducted to gain insight on the impact of the COVID-19 pandemic on biomanufacturing operations.
Formulating an ADC Development Solution
August 02, 2020
Development
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Many antibody-drug conjugate therapies are in the pipeline; only a handful have been approved. What are the bottlenecks?
Using Process Modeling to Troubleshoot a Bioprocess
August 02, 2020
Upstream Processing
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Process modeling offers an opportunity to troubleshoot for and anticipate difficult aspects of a bioprocess.
Points to Consider for Continuous Downstream Bioprocessing
August 01, 2020
Downstream Processing
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It is critical to evaluate specific considerations, from design to application, for the benefit of downstream bioprocessing and manufacturing.
CDMOs Build Fill/Finish Capacity for COVID-19 Vaccines
August 01, 2020
Downstream Processing
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Filling and packaging of primary containers is a crucial piece of COVID-19 vaccine production.
Aseptic Processing Practices: Reviewing Three Decades of Change
August 01, 2020
Manufacturing
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Technologies in use and on the horizon could change aseptic processing in ways that seemed inconceivable years ago but approaches to aseptic process validation still need to move beyond their 1970s roots.
Predicting Extractables and Leachables from Container Stoppers
August 01, 2020
Analytics
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Data from migration kinetics studies can be used to develop models that predict levels of leachables and extractables at different temperatures and time points.
Regulating Raw Materials Testing
August 01, 2020
Operations
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Efforts are already underway to harmonize standards and regulatory approaches for testing of raw and ancillary materials, but continuous improvement is required.
Global Regulatory Collaborations Aim to Speed Access to New Vaccines and Drugs
August 01, 2020
Regulatory Beat
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Efforts by regulators seek common approaches to clinical research and biopharmaceutical production needed to wipe out the coronavirus pandemic globally.
It’s Time to Listen to Science
August 01, 2020
From the Editor
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Time sure flies, except when you are waiting for something to happen.
Training During a Pandemic
August 01, 2020
Ask The Expert
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When in-person training may not be feasible, there are still opportunities to ensure employees receive the required training, says Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates.