Search results for " host cell protein"
Article
Evolution of the Monoclonal Antibody Purification Platform
The authors discuss the evolution of the purification platform for manufacturing of mAb therapeutics.
Monoclonal antibodies (mAb) increasingly form the majority share of the product pipeline…
Article
Emerging Therapies Test Existing Bioanalytical Methods
Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex thera…
Article
Improvements in Protein A Chromatography
You mention that you sometimes are asked “Why do you still use Protein A?” Why do you?
Protein A chromatography provides high yield while providing up to 3 logs of host cell protein removal and 4…
Article
Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
New approaches to vaccine production are targeting rapid supply for pandemic situations and broadly effective therapeutic treatments.
Following the 2009 outbreak of the H1N1 pandem…
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The Development and Application of a Monoclonal Antibody Purification Platform
…proteins (aggregates, degradation products, processing variants) and cell-derived impurities such as host cell protein (HCP) and cellular DNA. In response, platform purification processes for MAbs, i…
Article
Virus-like Particles as Therapeutic Moieties of the Future
Analytical and functional characterization of virus-like particles enables process reproducibility and product consistency.
By Ramesh Kumar, Manidipa Banerjee, Anurag S. Rathore
Virus-like…
Article
Moving PAT from Concept to Reality
Numerous at-line analyses evaluate host cell proteins (HCPs), DNA, viable cell density, bioburden, aggregates, product concentration, and particulates.
One of the greatest difficulties with many c…
Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Advances in cell culture media technology have helped achieve safer biologics.
By Tom Fletcher, Holden Harris
Regulatory expectations for cell-culture-based biologics production processes ch…
Article
Reimagining Affordable Biosimilars
MS also offers an excellent orthogonal approach to traditional immunochemical assays for host cell protein identification and quantification in ppm levels using cutting-edge LC–MS sample preparation a…
Article
Preclinical Evaluation of Product Related Impurities and Variants
Further, enzyme linked immunosorbent assay (ELISA) and PicoGreen assays were performed to measure levels of host cell proteins (HCPs) and host cell DNA (HCD), respectively.
Biological characte…