Search results for " process" in Articles / App Notes
Article
Advances in Engineering of Protein-Based APIs
…efficacy, enabling chronic treatment without liabilities, according to Jennitte Stevens, director of process development at Amgen. Generation of fully human antibodies is achieved in transgenic anima…
Article
Establishment of New Modern Plasma Fractionation Facilities in Asia
…n the late 1930s and early 1940s, but since that time, substantial improvements in the manufacturing processes have resulted in higher yields, a more diversified product range, and, most importantly,…
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Multidimensional Scale-Up of a Monoclonal Antibody Capture Step, Using ÄKTA™ pilot 600
Column volume per hour (CV/h) was utilized to enable maintaining residence time throughout the scaling process. The process, performed with MabSelect™ PrismA Protein A chromatography resin, was scaled…
Article
Concentration and Buffer Exchange Using the Automated, Single-Use ÄKTA™ readyflux System
The process was conducted in an automated manner based on methods created using phases predefined in the UNICORN™ system control software. Concentration of 5 g/L bovine serum albumin (BSA) was perfor…
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Handbook: Design of Experiments in Protein Production and Purification
Based on the obtained data, a mathematical model of the studied process (e.g., a protein puri cation protocol or a chromatography step) is created. The model can be used to understand the in uence of …
Article
Platform Technologies Improve Protein Expression
In addition to exploring novel production methods such as continuous processes and disposable production technology, manufacturers also heavily invest in platform technologies for protein expression t…
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N-Glycan Analysis of Biotherapeutic Proteins
…king the characterization of N-glycan structures an essential part of the biotherapeutic development process. The complex, branched structure of N-glycans present a unique analytical challenge. A var…
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Drug Quality Key to Innovation and Access
As 2016 came to a close, FDA officials reported that new drug approvals for the year would fall far short of the near-record set in 2015, raising concerns about current incentives and regulatory proce…
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Managing Risk in Raw Material Sourcing
By Agnes Shanley
Choosing excipients and suppliers for pharmaceutical formulations requires a clear understanding of product requirements; material properties; product, process, and material varia…
Article
Real Time Continuous Microbiological Monitoring
…ollecting counts under defined specifications, but rather it helps by showing that the manufacturing process is in a continuous state of control.
A real-time laser-induced fluorescence (LIF) syst…