Search results for " purity" in Articles / App Notes
Article
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
This update of a 2008 advisory describes how manufacturers should provide sufficient CMC information to assure the safety, identity, quality, purity, and strength/potency of investigational gene thera…
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
MCBs should be tested for identity (phenotypic and genotypic, if recombinant) and purity. While FDA, the European Medicines Agency, and the World Health Organization guidelines differ, testing must de…
Article
The Challenge of Disruptive Technologies in Bioprocessing
In addition, membrane absorbers have been suggested as a “disruptive alternative” to column steps for polishing a product to final purity (order of magnitude higher volume throughput). Other examples …
Article
Selection Guide: Columns and Resins for Antibody Purification and Immunoprecipitation
Polyclonal antibodies, monoclonal antibodies (mAbs), and antibody fragments are usually purified by affinity chromatography. Resins containing an immobilized ligand (e.g., protein A, protein G, or p…
Article
Putting Viral Clearance Capabilities to the Test
“Virus spike quality can influence the operation of key steps; for example, higher purity virus spikes are required for virus reduction filters to minimize virus induced flux decay and achieve the tar…
Article
Sanitization of ÄKTA™ pilot 600 Using Sodium Hydroxide
The ÄKTA pilot 600 chromatography system is designed to facilitate sanitization, with the high standards imposed by regulatory authorities for purity of the clinical products in mind. In this stu…
Article
Evaluation of Performance of a Disposable mAb Affinity Chromatography Column Used Over Multiple Process Cycles
Analysis of mAb purity and recovery as well as column bed integrity testing show that the column can be used with maintained performance for at least 50 cycles, providing significant process economic …
Article
Tools and Solutions for Separation of Charged mAb Variants
To attain regulatory approval, a comparable quality to the reference product in terms of efficacy, purity, and safety should be demonstrated. Biomolecules, however, exhibit high structural complexity …
Article
Preclinical Evaluation of Product Related Impurities and Variants
Statistical modelling using CEX content of each fraction as input and cell potency as output would help to parse the impact of each variant on cell potency without the need to isolate them in purity. …
Article
Techniques for Improving Process Development for Exosome-Derived Therapeutics
It can be difficult to isolate a large swath of the exosome population while achieving sufficient purity.
In the literature, the most commonly used approach for isolating exosomes is ultra-cen…