Search results for " bioreactor efficacy"

Article Right the First Time: Bioreactor Scale and Design Translation
Cell culture process transfer requires a good understanding of the physicochemical conditions within a bioreactor. This includes the hydrodynamic environment induced by the agitator and the …

Poster Adenovirus production in a single-use stirring tank bioreactor system
Adenovirus vectors are attractive delivery systems for vaccines and cancer treatment. Scalable and cost-efficient production technologies are needed to enable manufacturing of safe and efficacious c…

Article Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
This article will explore the traditional path from the laboratory to the clinic and how the fixed-bed technology provides an alternative solution to meet commercial demands. By Alex Chatel and …

Article Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech. By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…

Article Reimagining Affordable Biosimilars
Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.  By Anurag S. Rathore, Narendra Chirmule, and Himanshu Malani  Drug development is …

Article Implications of Cell Culture Conditions on Protein Glycosylation
The authors present a review of the techniques commonly used for glycosylation analysis. By Michiel E. Ultee, PhD, Dr. Richard Easton This article reviews the implications of cell-culture co…

Article QbD and PAT in Upstream and Downstream Processing
To gain perspective on the implementation of quality by design (QbD) and process analytical technology (PAT) in biopharmaceutical processing, BioPharm International spoke with Clinton Weber, as…

Article Unifying Continuous Biomanufacturing Operations
The success of a truly integrated continuous processing platform relies on the collaborative efforts of upstream and downstream specialists. By Randi Hernandez When human cells travel throug…

Article Perfusion in the 21st Century
Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing. By Bruce Lehr, Delia Lyons Cell-culture technology for biopharmaceutical manufact…

Article A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells. By Luhong He, Christopher Frye Abstract …

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