Regulatory - Bioprocess Development Forum

Articles Downstream Regulatory

April 22, 2021

Guide to Polishing Chromatography in Process Development

This article shares the factors you should consider when developing your polishing steps...

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Articles Downstream Regulatory Upstream

March 25, 2021

Basics in Process Development for Biotherapeutics

Definitions, activities, and things to consider when developing an upstream or downstream bioprocess.

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Articles BioPharma Downstream Regulatory Upstream

February 25, 2021

Remote Monitoring and Big Data Advance Upstream Automation

As upstream processing drives toward higher efficiencies in meeting demand, it requires optimizing...

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Articles BioPharma Downstream Regulatory Upstream

January 14, 2021

Updating Viral Clearance for New Biologic Modalities

Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities.

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Articles BioPharma Downstream Regulatory

December 17, 2020

Virus-like Particles as Therapeutic Moieties of the Future

Virus-like particles (VLPs) are viral capsid shells assembled without encapsulated nucleic acid.

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Articles Downstream Regulatory Upstream

November 5, 2020

Reimagining Affordable Biosimilars

Drug development is undergoing a transformation from multi-billion-dollar blockbusters to personalized...

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Articles BioPharma Downstream Regulatory

July 30, 2020

Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow

It is common for biologics manufacturing processes to require hundreds of raw materials...

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Articles Downstream Regulatory Upstream

July 16, 2020

Eliminating Residual Impurities Starts with a Strategic Plan

Residual impurity testing is essential to ensure the quality and safety of pharmaceutical products...

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Articles BioPharma Downstream Regulatory Upstream

June 4, 2020

Biomanufacturing: Demand for Continuous Bioprocessing Increasing

In nearly all other manufacturing technologies, cost considerations dictate that...

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Articles BioPharma Downstream Regulatory Upstream

May 21, 2020

Gene Therapies Push Viral Vector Production

Several virus types have been studied for use as viral vectors in gene therapy, including…

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