Search results for " fragments"
Article
Selecting the Right Viral Clearance Technology
By Cynthia Challener, PhD
The introduction of adventitious viral agents is a recognized, inherent risk of biologic drug production that is well addressed by international regulatory requirements…
Article
Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
Figure 3: Selectivity between monoclonal antibody (mAb) monomers and aggregates at a higher sample load following the optimized first polishing step in a lab-scale column, showing the percentage of fr…
Article
Re-use of Protein A Resin: Fouling and Economics
Proteases in harvested cell culture fluid are known to be responsible for proteolytic cleavage of Protein A ligand into fragments ranging in molecular weight from six to 40 kDa (27). Protein A ligand …
Article
Fermentation for the Future
Newer drug substances, such as single-domain antibodies, peptibodies, or antibody fragments that contain the effective domains, have recently been produced using microbes.
Microbial expression is …
Article
Optimizing Resin Performance with Disposable Chromatography Solutions
…ns based on Protein L) for the purification of a next-generation of biotherapeutics such as antibody fragments.
Tingley (Repligen): Yes, the single-use chromatography products we are discussing w…
Article
Analyzing Proteins Using SEC, MALS, and UHPLC
They also often do not consist of discreet populations, such as monomers and low oligomers or fragments. “Real proteins may be partially or completely disordered, contain significant hydrophobic resid…
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
EMA Collaborates with HTA Assessment Networks
High technology assessments are having an impact on biosimilars development in Europe.
Gaining access to Europe’s pharmaceutical markets has become a multi-stage operation. The licensing of a…
Article
Early Communication with Regulators is Essential for SMEs
With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regulators early in the drug-development process.
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Article
A Platform Approach for the Purification of Domain Antibodies (Dabs)
This Application note describes a three-step purification process of a domain antibody (Dab) expressed in the periplasm of E. coli. First, a capture step using Capto™ L was used to reduce E. coli host…