Articles - Bioprocess Development Forum

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 Downstream Upstream

September 1, 2014

Challenges of Protein Aggregation During Purification

Removal of protein aggregates from biologic APIs is crucial due to their potential to increase...

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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 Downstream

July 17, 2014

Analyzing Proteins Using SEC, MALS, and UHPLC

Light scattering analysis combined with more rapid size exclusion chromatography improves protein...

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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

March 15, 2014

Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle

With the most recent FDA (1) and Inter-national Conference on Har-monization (ICH) guidances...

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Articles Downstream

January 27, 2014

Determining Criticality, Part Two: DoE and Data-Driven Criticality

A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental...

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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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