Search results for " system" in Articles / App Notes
Article
Reimagining Affordable Biosimilars
Limitations of clinical studies
Clinical trials have long served as the gold standard for evaluating safety and efficacy of drugs in a systematic manner using established, robust statistical pro…
Article
The Importance of Partnering for Bioanalytical Studies
This requires companies having a quality system in place, regular audit of the facility, maintaining documentation, training records, instrument qualification, and so on, all of which often becomes to…
Article
Can Vaccine Development Be Safely Accelerated?
… swine flu), have the common feature that they simply had never been seen before by the human immune system. That said, we now know a lot about how the human immune system protects against viral infe…
Article
2019’s Top Bioprocessing Trends and What to Expect in 2020
Readers were particularly interested in learning how Fibro technology can be used in conjunction with ÄKTA™ chromatography systems and autosamplers to reduce process time significantly when compa…
Article
Moving PAT from Concept to Reality
Braatz is looking forward when cost of LC–MS systems is reduced sufficiently to allow widespread adoption for real-time monitoring of bioprocesses. He notes that few people in the 1980s would have exp…
Article
Scaling Up Novel Therapies
In addition, the equipment footprint was reduced by four or five fold, and the systems enabled, at large scale, a 40–50% savings in Protein A resin use, he says.
High operational and capital c…
Article
A Look into the Future of Biopharmaceutical Quality
The current processes used to update procedures, systems, and filings may not be able to keep pace with the rapid introduction of technological advances. I don’t think this is new. Science has always …
Article
Understanding Validation and Technical Transfer, Part 3
A formal change control system must be in place, and any proposed change must be evaluated, reviewed, and approved prior to implementation. Change records must be current, up to date, supplement the o…
Article
Leveraging Data for Better Biopharmaceutical Process Control
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Menezes: We see a significant change in how advanced control practices from other processing and systems engineering areas are today applied in biopharma. The realization that in bioprocessing th…
Article
Your Protein Purification Questions Discussed
Questions about chromatography techniques, troubleshooting tips and tricks, and the use of ÄKTA systems were submitted in writing by protein purifiers globally.
We have included the questio…