Search results for " laboratory" in Articles / App Notes
Article
Moving PAT from Concept to Reality
Microfluidic devices and contact-free PAT technologies are among the most recent advances but are still mostly in the laboratory proof-of-concept stages, according to Carbonell. “Microfluidics-based a…
Article
What’s New in Upstream Technologies
Recent upstream processing innovations include enhanced sensor technology, single-use bioreactors, and automated cell culture systems.
By Amber Lowry
SCIENCE PHOTO - STOCK.A…
Article
Case Study: Virus Reduction of an Affinity Capture Step
The study was performed by a third-party viral testing laboratory in collaboration with a biopharmaceutical company.
Read case study
Article
Science Focus Fuels Successful Process Development for Startups
Because few cell and gene therapies have yet to be approved, most work has been performed in laboratory equipment; commercial solutions are limited to a few plug-and-play options, according to Sharei.…
Article
A Look at the Affinity Chromatography Landscape
A Look at the Affinity Chromatography Landscape
New ligands are being developed to meet the separation and purification needs of next-gen biologics.
By Cynthia A. Challener
…
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
In 2014, using next-generation sequencing (NGS), FDA’s Center for Biologics Evaluation and Research (CBER) retrovirus laboratory identified a novel rhabdovirus in Spodoptera frugiperda type 9 (Sf9) ce…
Article
Understanding Validation and Technical Transfer, Part 3
Initially, development information can be kept in research or laboratory notebooks, but as clinical use becomes likely, formal development reports and initial validation work should be prepared, revie…
Article
Leveraging Data for Better Biopharmaceutical Process Control
“Near-Infrared Spectroscopy in Laboratory and Process Analysis,” Encyclopedia of Analytical Chemistry (Wiley, 2012) DOI:10.1002/9780470027318.a9361
4. “Spectroscopic finger-printing of raw mater…
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
Understanding Validation and Technical Transfer, Part I
Biopharmaceuticals are often complex molecules, or mixtures of molecules, produced in biological systems and it is not always possible to fully characterize these products in the laboratory. Therefore…