Search results for " control" in Articles / App Notes
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
Exotoxin Clearance from mAb Samples in a Two-Step Chromatography Process
A heat-stable exotoxin can remain as a contaminant of a drug substance throughout the whole manufacturing process, with the risk of adversely affecting patients’ health. One such toxin is cereulide …
Article
Preclinical Evaluation of Product Related Impurities and Variants
The level of these species, however, is usually controllable through fermentation and purification steps. There is no consensus among the regulatory agencies on the maximum allowable limit for these s…
Article
Process Development: What May Lie Ahead in 2018?
…Protein A Chromatography
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Prepare for an FDA Bioburden Inspection
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Bioburden Control in the Biopharmaceutical Industry
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Impact of Media Components on CQAs of Monoclon…
Article
What's in Your SOP?
Schniepp
Q: I recently transferred to the document control department and am working with people on creating and/or revising standard operating procedures (SOPs). My co…
Article
Reliability Rooms and the Move to Proactive Supply Chain Management
Thresholds then indicate whether or not the problem is under control.
For example, there is a statistical correlation between certain metrics that are associated with stock outs in specific mark…
Article
Roadmap Leads to Innovative Biomanufacturing Strategies
The focus of the Biomanufacturing Technology Roadmap is on the chemistry, manufacturing, and controls (CMC) side of drug commercialization. For most companies, CMC-based technologies are not different…
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…
Article
Platform Technologies Improve Protein Expression
They are also expected to speed up the development of novel specific molecules based on the use of chemistry, manufacturing, and controls (CMC) standards and by leveraging capabilities and capacities,…
Article
Tips for Successful Immunoprecipitation
For immunoprecipitation (IP), there are four main components that you can control to get good results: protocol, resin, format, and antibody. Read these tips to get it right from the start.
Ac…