BioPharma - Bioprocess Development Forum

Articles BioPharma Downstream Regulatory

February 15, 2018

Preclinical Evaluation of Product Related Impurities and Variants

The approaches for sample preparation of preclinical evaluation of safety and efficacy are...

admin-element

Articles BioPharma Regulatory

November 16, 2017

Evaluating Surface Cleanliness Using a Risk-Based Approach

Regulated companies that use automated cleaning applications have always struggled with correlating...

admin-element

Articles BioPharma Downstream Regulatory Upstream

September 21, 2017

Bioburden Control in the Biopharmaceutical Industry

The biopharmaceutical industry has witnessed tremendous breakthroughs during the past few years. However, this advancement...

admin-element

Articles BioPharma Downstream

September 21, 2017

Impact of Media Components on CQAs of Monoclonal Antibodies

Recombinant protein products have made a revolutionary impact on human healthcare by enabling mass...

admin-element

Articles BioPharma Downstream Regulatory Upstream

September 7, 2017

The Role of Quality Standards for Biomanufacturing Raw Materials

Successful pharmaceutical manufacturing strategies depend on raw materials that are of good quality.

admin-element

Articles BioPharma Downstream Upstream

August 11, 2017

Process Chromatography: Continuous Optimization

Cell-culture and fermentation are high-yielding processes that effectively produce...

admin-element

Articles BioPharma Regulatory

June 28, 2017

N-Glycan Analysis of Biotherapeutic Proteins

This article summarizes the approaches, challenges, and future perspectives for the characterization...

admin-element

Articles BioPharma Downstream Regulatory

May 4, 2017

Being Thorough When Transferring Technology

Tech transfer and scale up of biologics can be as complicated as biologic therapies themselves.

admin-element

Articles BioPharma

April 19, 2017

Critical Quality Attributes Challenge Biologics Development

Critical quality attributes (CQAs) are used in biopharmaceutical development to gain an...

admin-element

Articles BioPharma Downstream Regulatory Upstream

April 5, 2017

Single-use Bioreactors Have Reached the Big Time

Single-use bioreactors available from various vendors today are robust and provide the high-performance...

admin-element