Search results for " impurities" in Articles / App Notes
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
…ncentration of all components is known and of high purity with only minimal levels of trace chemical impurities.
The following sections address viral risk mitigation across the five a…
Article
Challenges in Analytical Method Development and Validation
The new FDA draft guidance recommends that forced degradation samples or samples containing pertinent product-related impurities should be analyzed at both labs for a stability indicating method. For …
Article
Considerations in depth filter scale-up
Depth filters are widely used in the biopharmaceutical industry. They are typically made of a mixture of cellulose, filter aids, and a binder. These components can be milled and mixed in diffe…
Article
Purification strategies for antibody-derived entities: bispecifics and fragments
The diversity of antibody variants in today’s pipeline presents unique challenges for purification. Purification platforms used for many monoclonal antibodies (mAbs) need to be adopted for ant…
Article
Alternative solutions to separate AAV full and empty capsids using anion exchange
Adeno-associated virus (AAV) is the main vector for gene therapy and there is need for scalable, cost-efficient, and robust chromatography-based purification. Key for a successful process are …
Article
Exosome isolation by tangential flow filtration and size exclusion chromatography
We found that:
- Cytiva™ superSEC resin enriched exosomes from impurities compared to legacy Sepharose™ CL-2B resin—a well-established resin for exosome purification—after the initial TFF step.
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Article
Selecting Chromatography Resins for Bispecific Antibody Purification
Their purification can be more challenging than traditional monoclonal antibodies (mAbs), however, due to the increased level of product-related impurities with high similarity to the desired bsAbs. A…
Article
Chromatography innovations for the diversified antibody pipeline
Our MabSelect™ VH3 affinity resin interacts with the variable heavy chain of the VH3 sequence family of human antibody, delivering high binding capacity and efficient separation of product-related imp…
Article
Host cell protein quantitation using ELISA
Host cell proteins (HCPs) produced by cells during biologic manufacturing must be removed from the final product to protect patients. However, it’s challenging to detect HCP, and this step c…
Article
How to develop a scalable rAAV process
Adeno-associated virus (AAV) is the most common vector for gene therapy, yet there’s much room to improve production, purification, and analytics. Here we present the latest updates to our wor…