Search results for " impurities" in Articles / App Notes
Article
Eliminating Residual Impurities Starts with a Strategic Plan
A risk-based approach to identifying potential residual impurities is important for understanding any risks to the product quality and potentially the patient. It also allows the development of an opt…
Article
Impurity Testing of Biologic Drug Products
Some impurities (especially host cell proteins) may add an immune-stimulating or adjuvant behavior to the therapeutic, causing the patient to generate antibodies or cell-mediated immunity against the …
Article
Managing Residual Impurities During Downstream Processing
Elemental impurities can be present as well. There is, however, no set of standard assays for the determination of contaminants such as HCPs during manufacturing because each biopharmaceutical process…
Article
Preclinical Evaluation of Product Related Impurities and Variants
Often, these processing steps result in formation of certain molecular variants and impurities in addition to the pure GCSF. These include the oxidized, formyl methionine (f-Met), reduced, and aggrega…
Article
Capture of Bispecific Antibodies and Removal of Product-Related Impurities
Many of these variants, especially asymmetric bispecific antibodies, are prone to aggregation or to forming product-related impurities such as homodimers and half antibodies during cell culture. The s…
Article
Impurity ELISA automation for faster process development
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 can…
Article
Paring Down Impurities in Downstream Processing
Myriad choices confront manufacturers before they even consider optimizing downstream processes. Each decision directly influences what final options will be available on arriving at the final…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
• Purity: The procedure must be able to accurately quantify all related impurities relative to examplain HCl in the presence of drug substance and other impurities over a range from the reporting thre…
Article
Quality by design for biotechnology products—part 1
They include but are not limited to product-related variants, process-related impurities, formulation parameters, and essential attributes such as appearance. Examples of process-related impurities in…
Article
Evolution of the Monoclonal Antibody Purification Platform
Typical steps include:
• Protein A chromatography for capture of the product and removal of host cell-related impurities (host cell proteins and DNA). Though extremely efficient and effective,…