Search results for " reliability" in Articles / App Notes
Article
Biopharma Says It Has an Evolution in New Technologies and Processes
This week, the Process Development Forum interviews Rita Peters, editorial director of BioPharm International, about Interphex 2018.
At the 2018 Interphex trade show in New York City in April…
Article
NIST Spectroscopic Measurement Standards
NIST Spectroscopic Measurement Standards
The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082 as a pathlength standard for UV absorbance mea…
Article
Making the Move to Continuous Chromatography
Making the Move to Continuous Chromatography
Early adopters are benefiting from lower costs and increased productivity.
By Cynthia A. Challener
Tashatuvango/Shu…
Article
What's in Your SOP?
What’s in Your SOP?
SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
…
Article
Reducing Cross-Contamination Risks in Process Chromatography
Reducing Cross-Contamination Risks in Process Chromatography
Single-use systems provide replaceable fluid paths.
By Cynthia A. Challener
…
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
But the experts sought assurance of security, accuracy, and reliability for Novartis’ complex system for removing blood T-cells from the patient, cryopreserving them for transport to a company proces…
Article
Best Practices for Data Integrity
Best Practices for Data Integrity
Optimize practices and meet requirements using electronic data integrity systems.
By Jennifer Markarian
Maintainin…
Article
From Darwin to Recombinant Fc Multimers
…nology such as Surface Plasmon Resonance also could be beneficial in plasma analytics, with improved reliability and with a high degree of simplification. Data for all subclasses of IgG, albumin, Ig …
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
Now that biosimilars are here to stay, manufacturers are developing processes for cost efficiency and reliability using newer technology to compete with innovator products based on processes 10-15 yea…
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
Surrogate sample bags were utilized for adding thermal mass for the large-scale freezing experiments at -80 ˚C, to ensure reliability of freezing temperature profiles. The temperature profiles were r…