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Article Gene Therapies Push Viral Vector Production
Gene Therapies Push Viral Vector Production Viral vectors show promise as a delivery mechanism for gene therapy, but which virus types are commercially viable? By Feliza Miraso…

Article Best Practices for Selecting a Top-Quality Cell Line
“Recombinant biotherapeutic proteins can misfold and stress the secretory pathway, leading to protein degradation or cell death, multi-chain biotherapeutic proteins may not pair properly, or perhaps g…

Article Cell-Culture Advances Test Bioreactor Performance Models
The evolution of cell-culture technology is driving the need for improvements in modeling solutions. By Cynthia A. Challener  Modeling and simulation are recognized to provide assistance i…

Article Understanding Validation and Technical Transfer, Part 3
Issues such as cell degradation and pyrogen formation should be evaluated, as should any process fluid and equipment sterilization procedures. If controlled environments are necessary, validation stud…

Article Impurity Testing of Biologic Drug Products
…ion for primary amino-acid sequencing, which could be completed by N-terminal sequencing using Edman degradation. The same type of methodology can be applied to the evaluation of the most common post…

Article Evaluating Surface Cleanliness Using a Risk-Based Approach
Evaluating Surface Cleanliness Using a Risk-Based Approach Rinse sample analysis or visual inspection can be correlated to surface cleanliness to replace surface sampling. By Elizabeth Rivera…

Article Impact of Media Components on CQAs of Monoclonal Antibodies
The authors review how media components modulate the quality of monoclonal antibody products.  By Anurag Rathore, Rajinder Kaur, Dipankar Borgayari  Recombinant protein products have…

Article Managing Residual Impurities During Downstream Processing
Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures. By Cynthia A. Challener Manufacture of protein and other biologic drug substances via …

Article Fusion Proteins Pose Manufacturability Challenges
Some fusion proteins are also prone to proteolytic degradation during production and/or after therapeutic administration, according to Carter. This issue can sometimes be overcome by modifying the jun…

Article Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
The necessity to detach cells from a culture substrate during cell harvesting remains one of the most challenging steps in a cell-culture process. By Marcos Simon, Juan J. Giner-Casares Cell…