Regulatory - Bioprocess Development Forum

Articles Downstream Regulatory Upstream

June 4, 2015

Host-Cell Protein Measurement and Control

Host-cell proteins (HCPs) constitute a major part of process-related impurities during biologics...

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Articles BioPharma Downstream Regulatory

May 1, 2015

Modular Manufacturing Platforms for Biologics

It should come as no surprise that the good design principles governing pharmaceutical manufacturing…

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Articles Regulatory

April 8, 2015

USP Publishes Monoclonal Antibody Guidelines

As FDA gears up towards approving biosimilar drugs in the United States, it is unquestionable...

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Articles BioPharma Downstream Regulatory Upstream

April 8, 2015

Continuous Manufacturing: A Changing Processing Paradigm

Although continuous manufacturing is well established for bulk chemicals, complex automation and...

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Articles BioPharma Downstream Regulatory Upstream

April 6, 2015

Use of Multivariate Data Analysis in Bioprocessing

The ever increasing demand of biotherapeutics, together with the pressure to contain healthcare...

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Articles BioPharma Regulatory

March 26, 2015

Detecting Protein Aggregates and Evaluating their Immunogenicity

Aggregation in biopharmaceuticals remains a major concern and threatens the stability of a product.

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Articles Regulatory

November 12, 2014

Setting Standards for Biotech Therapeutics in India

The past decade has seen considerable growth in the Indian pharmaceutical industry. India has...

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Articles Downstream Regulatory Upstream

November 1, 2014

Viral Clearance Challenges in Bioprocessing

Removal and inactivation of adventitious and endogenous viruses have traditionally been achieved...

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Articles BioPharma Regulatory

October 29, 2014

Continued Process Verification for Biopharma Manufacturing

Continued process verification (CPV) is the activity that provides ongoing verification of the...

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Articles BioPharma Downstream Regulatory Upstream

October 29, 2014

Application of Quality by Design to Viral Safety

The biotech industry has begun to implement a quality-by-design (QbD) approach to ensure the...

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