Regulatory - Bioprocess Development Forum

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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Articles BioPharma Downstream Regulatory

September 27, 2018

Ensuring Viral Safety of Viral Vaccines and Vectors

Vaccines, including viral vaccines, are a crucial invention in human history and continue to...

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