Search results for " chromatography"
Article
Use of Multivariate Data Analysis in Bioprocessing
… spectroscopic measurements, analysis of data profiles from unit operations such as cell culture and chromatography, quantitative assessment of process comparability, root cause analysis, and raw mat…
Article
Viral Clearance Challenges in Bioprocessing
…moval could be demonstrated under standard conditions like low pH inactivation, anion exchange (AEX) chromatography, or virus-retentive filtration? Further studies need to be performed to answer thes…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
In the case examples discussed in this article, following such a discussion between R&D and receiving laboratory analytical scientists, reversed-phase high-performance liquid chromatography (RP-HPLC) …
Article
Biopharma Moves to Integrated, Single-Use, Downstream Processing
She notes that the adoption of pre-packed, limited-use chromatography in the industry has been particularly slow, even though the value proposition for early clinical phase manufacturing is clear (tim…
Article
Process development using a nonaffinity method vs Cytiva™ Protein Select™ resin
The first method is using nonaffinity chromatography steps (AIEX + heat treatment + HIC), while the second method is using the novel affinity Cytiva™ Protein Select™ resin for the capture step, follow…
Webcast
Webinar: Intensifying Downstream Bioprocessing With Continuous Technologies
We will discuss:
-Intensification of capture chromatography and the benefits of coupling with viral inactivation
-How a single flow through chromatography step can simplify polishing
-The rol…
Article
Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
Sterility must be assured for all biologic drug products. Terminal sterilization achieved via treatment with heat, radiation, or certain chemicals (vaporous hydrogen peroxide, vaporous peracet…
Article
Purification strategies for antibody-derived entities: bispecifics and fragments
The diversity of antibody variants in today’s pipeline presents unique challenges for purification. Purification platforms used for many monoclonal antibodies (mAbs) need to be adopted for ant…
Article
Life cycle assessment of the protein A process in mAb manufacturing
Here we present a cradle-to-grave LCA for protein A chromatography resins in the capture step of mAb manufacturing. The focus is on the resin use phase, although resin manufacturing, packaging, distri…
Article
Alternative solutions to separate AAV full and empty capsids using anion exchange
Here we present high-performance anion exchange (AEX) chromatography separation for several AAV serotypes using step-elution mode. Optimized protocols and conditions for both resin and membrane format…