Regulatory - Bioprocess Development Forum

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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Articles Regulatory

October 17, 2014

Using Quality by Design to Develop Robust Chromatographic Methods

The quality-by-design principles that enable a manufacturer to limit and control the sources of process…

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Articles BioPharma Regulatory

October 1, 2014

Challenges and Trends in Biopharma Facility Design

Experts discuss the future of modular manufacturing and the challenges that biopharma manufacturers...

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Articles Regulatory

September 18, 2014

Evaluating Design Margin, Edge of Failure and Process

A product’s or process’ design space is generally considered to be the area where process...

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Articles BioPharma Regulatory

July 18, 2014

Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products

A critical quality attribute (CQA) has been defined as “a physical, chemical, biological...

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Articles BioPharma Regulatory

June 13, 2014

Challenges in Analytical Method Development and Validation

The manufacture of biopharmaceuticals presents some unique challenges when ensuring...

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Articles Downstream Regulatory Upstream

January 13, 2014

PDA’s Technical Report for Biotech Cleaning Validation

Cleaning validation plays an important role in reducing the possibility of product contamination...

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Articles BioPharma Regulatory

December 29, 2013

Quality by design for biotechnology products—part 1

Quality by Design (QbD) is a concept applied to the design and development...

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