Articles - 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...

admin-element

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...

admin-element

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...

admin-element

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…

admin-element

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...

admin-element

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...

admin-element

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...

admin-element

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...

admin-element

Articles Downstream

July 17, 2014

Analyzing Proteins Using SEC, MALS, and UHPLC

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

admin-element

Articles BioPharma Regulatory

June 13, 2014

Challenges in Analytical Method Development and Validation

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

admin-element