Search results for " control"
Article
Fifteen Years of Progress: Biopharmaceutical Industry Survey Results
…sables, trends and budgets in disposables, trends in downstream purification, quality management and control, hiring issues, and employment. The quantitative trend analysis provides details and compa…
Article
Miniaturization to Become Even More Successful
Industrial bioprocess development has changed significantly in the last decade, driven primarily by two major factors: ever-rising R&D costs of developing therapeutic candidates with simultaneous de…
Article
Putting Viral Clearance Capabilities to the Test
“A detailed risk assessment covering all aspects of the manufacturing process demonstrates an understanding and control of the process and provides a framework to evaluate the impact of each change bo…
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
·
Prepare for an FDA Bioburden Inspection
·
Bioburden Control in the Biopharmaceutical Industry
·
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…