Search results for " mAbs"

Article New Therapies Present Scaling Challenges
New Therapies Present Scaling Challenges Manufacturing differences between traditional mAb therapies and newer biotherapeutics dictate whether processes should be scaled up, scaled out, or use an al…

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 Antibody Production in Microbial Hosts
The authors review the status of expression of antibodies in microbial hosts and present the recent advances in the production of aglycosylated antibodies in bacteria. By Anurag S. Rathore, Jyot…

Article Comparing Protein A Resins for Monoclonal Antibody Purification
A prototype Protein A resin is evaluated for purification performance, reusability, and cost performance. With greater economic pressure on monoclonal antibody (mAb) production for therapeutic …

Article Design Considerations for a Commercial Cell and Gene Therapy Facility
The commercialization of cell and gene therapies has become a reality, prompting deeper considerations of logistics, technology, and design for manufacturing facilities. By Feliza Mirasol …

Article N-Glycan Analysis of Biotherapeutic Proteins
This article summarizes the approaches, challenges, and future perspectives for the characterization of N-glycans in biopharmaceutical products. By Aled Jones Protein glycosylation, the addi…

Article Preclinical Evaluation of Product Related Impurities and Variants
Preclinical Evaluation of Product Related Impurities and Variants The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the s…

Article Process Chromatography: Continuous Optimization
Improved resin chemistries and customized separation solutions are enabling more efficient separations. By Cynthia A. Challener Cell-culture and fermentation are high-…

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 Advances in Engineering of Protein-Based APIs
Advances in Engineering of Protein-Based APIs New platform technologies, advanced modeling tools, and addressing patient needs are important developments. By Cynthia A. Challener …

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