Regulatory - Bioprocess Development Forum

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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Articles BioPharma Regulatory

March 26, 2020

Can Vaccine Development Be Safely Accelerated?

Human coronaviruses (HCoVs) in the past were considered to cause nothing more than the...

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Articles Downstream Regulatory

October 24, 2019

Best Practices for Selecting a Top-Quality Cell Line

Leveraging automation and a step-by-step approach are keys to success. Cell lines determine the...

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Articles Downstream Regulatory Upstream

July 18, 2019

Design Considerations for a Commercial Cell and Gene Therapy Facility

The commercialization of cell and gene therapies has become a reality, prompting deeper...

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Articles BioPharma Downstream Regulatory Upstream

July 2, 2019

Addressing the Complex Nature of Downstream Processing with QbD

Regulators have been encouraging bio/pharmaceutical companies to incorporate the concept of...

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Articles BioPharma Downstream Regulatory Upstream

June 20, 2019

Moving PAT from Concept to Reality

Process analytical technology (PAT) is applied in the biopharmaceutical industry for analysis of raw...

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Articles Regulatory

March 19, 2019

An Analytical Approach to Biosimilar Drug Development

The long-term safety and efficacy of biosimilars are largely based on clinical studies that have...

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Articles BioPharma Regulatory

March 14, 2019

Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars

Biotherapeutics are an emerging class of treatment modalities that are manufactured...

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BioPharma BioPharma Q&A Regulatory Regulatory

February 14, 2019

Supply Chain Challenges for Single-Use Systems

The implementation of single-use systems (SUS) for biopharmaceutical manufacturing as an alternative...

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Articles BioPharma Downstream Regulatory

December 20, 2018

Achieving Process Balance with Perfusion Bioreactors

Perfusion cell-culture processes have been used for more than two decades for the production of...

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