Search results for " purity"
Article
Setting Up Bioprocessing Systems for Digital Transformation
Harvey Branton, technology lead, Biologics, CPI, uses the following as a “for example” scenario: step elutions tend to be used from chromatography columns so that the product purity is based on a fixe…
Article
The Importance of Process Intensification and PAT for Achieving Real-Time Release
Electrophoretic technologies, which are the gold standard for purity, charge heterogeneity, and other analyses, present more challenges due to the need for sample preparation. Mass spectrometry is of …
Article
Virus-like Particles as Therapeutic Moieties of the Future
Sodium dodecyl sulphate–polyacrylamide gel electrophoresis (SDS–PAGE) can be used to analyze the molecular weight and protein purity of VLPs. The identity of individual capsid proteins can be confirme…
Article
Technology Innovations Improve Process Chromatography Performance
Specific affinity resins are also being developed that enable an effective and straightforward capture step that results in high purity. We can see this trend in new biological targets (e.g., adeno-as…
Article
Design Considerations for a Commercial Cell and Gene Therapy Facility
For biologics and viral vectors, the cells are a byproduct of production and, thus, often get lysed and discarded in the downstream process, which is designed to optimize both the yield and the purity…
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Case Study: Oncolytic Adenovirus Production
Oncolytic viruses constitute a promising therapeutic approach for treatment of cancer. These viruses selectively replicate in tumor cells and effectively kill these cells without harming normal cell…
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
In order to provide the purity component found in methods such as CE and cationic exchange chromatography, MAM incorporated a new peak detection feature, Rogers explained, so that differential analysi…
Article
Science Focus Fuels Successful Process Development for Startups
On the other hand, she notes that the small group was nimble, very focused, had great tenacity, learned quickly, and was able to make great strides in improving the yield, purity, efficacy, and cycle …
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An Analytical Approach to Biosimilar Drug Development
Specifically, these tests are designed to cover the primary, secondary, and higher order of protein structures; the purity and impurities; the post-translational modification, such as glycan profiles;…
Article
Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
…on't Get Tied Down by Bed Height
• Combine Chromatography Techniques: Get the Right Purity/Yield of Protein
• Impurity Testing of Biologic Drug Products
• Tools and Solutions for S…