Search results for " comparability"
Article
What is process development?
What is process development?
Biopharma process development comprises the activities that help you create a series of steps to produce a biomolecule – a monoclonal antibody (mAb), recomb…
Article
Top Process Development Trends for 2022 and a Look into 2023
FDA approved 37 drugs in 2022, within the normal range for the past decade or so. The European Medicines Agency (EMA) was even more successful—approving a record 55 therapies. More than half of thes…
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Designing a 1.5 L Bench-Scale Model of a Perfusion Process
Establishing an appropriate model allows for higher throughput during simultaneous operation and monitoring of several cultures at different process conditions. In this article, we discus…
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What’s in your media? How costly is variability of cell culture media to your manufacturing process?
Manufacturing
In this video, Christopher Woolstenhulme, Lead Analytical Scientist of Manufacturing Sciences at Cytiva, is interviewed by BioPharm International and provides insight into t…
Article
Need solutions for large-scale production of mRNA-based molecules?
Therapies based on messenger RNA, such as mRNA vaccines, have revolutionary potential. mRNA therapeutics offer precise and individualized therapy and avoid manufacturing issues associated wit…
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Scaling Up an E. coli Upstream Process for Plasmid DNA Production — from 2.5 to 160 L scale Fermenters
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This article summarizes the results of Escherichia coli growth performance for plasmid production in a 5 L glass fermentor, which was scaled up to 80 and 160 L scale in Xcellerex™ X…
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Achieving the Required Buffer Quality with Inline Conditioning
Buffer production often becomes a limiting factor when the goal is to design more flexible facilities. To overcome this, Janssen Biologics BV decided to investigate inline conditioning (IC) technology…
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Novavax Reports on Two Vaccine Efficacy Studies
Novavax’s COVID-19 vaccine is 90.4% effective and maintains efficacy when administered with an influenza vaccine.
Novavax announced on June 14, 2021, results from two studies of is recombinant…
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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
Evaluation of Fibro PrismA for Scalable Single-Use mAb Purification
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In clinical monoclonal antibody (mAb) manufacturing, capture on protein A chromatography resin gives excellent recovery and purity. However, because clinical batch siz…