Search results for " impurities" in Articles / App Notes
Article
As the therapeutic pipeline diversifies, chromatography toolboxes are expanding.
Depending on the structure of the target antibody and the impurity profile, other affinities, like protein L or variants of protein A, may improve purity and increase removal of impurities.
Cytiva…
Article
Optimizing capture and polishing steps in an rAAV purification process
In this article, we show how we developed an efficient purification process for recombinant AAV (rAAV). The chromatography purification described includes affinity capture to maxi…
Article
Innovative Chromatography Resins Can Improve Purity and Quality
He concluded that conventional multi-step DSP development bears the increased risk of commercial viability, where yield, impurity levels (such as host cell proteins or product-related impurities) or o…
Article
Biosimilar Quality Requirements
Factors to consider include the expression system, the manufacturing process, physicochemical properties, functional activities, target binding, impurities, the reference product and reference standar…
Article
Getting it Right from the Start in the Drug Development Process
These effects can result in process-related impurities, product impurities, and post-translational modifications.
Click here to read more on how the use of surface plasmon resonance (SPR) te…
Article
Addressing the Complex Nature of Downstream Processing with QbD
The removal of product-related impurities is another challenge, according to Malmquist. “In these instances, characterization of the interplay and impact of process parameters and raw material attribu…
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
…rmal phase (NP) or hydrophilic interaction chromatography (HIC), are used to analyze CQAs and detect impurities that are introduced by deamidation, isomerization, oxidation, and glycosylation, during…
Article
Understanding Validation and Technical Transfer, Part 3
The cell isolation process can be validated for the particular type of cells that are collected, including studies to ensure the cells are not damaged during the process and impurities are removed to …
Article
Cleaning Protein A Resins with 1 M NaOH
If not removed, these impurities can build up on the protein A resin and start to leach into the process material in subsequent cycles. The presence of cell culture nutrients in the harvest feed loade…
Article
Reconciling Sensor Communication Gaps
By Angelo DePalma, Ph.D.
Process analytical technology (PAT), quality by design, and individual company- or process-centric quality initiatives are driving the development of bioprocess sensors …