Search results for " host cell"
Article
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
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
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…
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…
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
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
Ensuring the Biological Integrity of Raw Materials
They rely on the host for reproduction, and sometimes incorporate their genetic material into the host cell’s genome. Viral contamination is generally the greatest contamination risk because of the ab…
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
Optimizing Late-Stage and Commercial Cell-Culture Processes
…s valuable modeling input; it can shorten the development period for complex molecules or unfamiliar host cell lines (e.g., in-licensed molecules),” says Laird.
“In a commercial-manufacturing …
Article
Development of Purification for Challenging Fc-Fusion Proteins
As tested on three Fc-fusion proteins, this process demonstrates high process yield, improved clearance of HMWs and LMWs, and efficient reduction of host cell proteins (HCP) and DNA as well as robust …