Search results for " laboratory"
Article
N-Glycan Analysis of Biotherapeutic Proteins
(Cold Spring Harbor Laboratory Press, Cold Spring Harbor, NY, 2nd ed., 2009), 23-36.
8. S. Houel et al., Anal. Chem. 86, 576-584 (2014).
9. J.F. Valliere-Douglass et al., J. Biol. Chem…
Article
Evaluating E&L Studies for Single-Use Systems
were used and extractions were done singularly within the laboratory, without involving the entire production area. Therefore, this option seemed simpler to perform. Furthermore, as most of the materi…
Article
Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
Process scale
Manual cell-detachment techniques such as cell scraping may be adequate at laboratory scale but unfeasible at industrial scale due to the laboriousness of the method.
Reusability…
Article
Viral Clearance Challenges in Bioprocessing
These assessments of process excursions require open communication between the biologics manufacturer and the testing laboratory to develop comprehensive evaluation plans, according to Greenhalgh.
…
Article
Pharma Investments Reflect Key Industry Trends
In March 2014, GSK announced plans to invest as much as £130 million ($222 million) in five African manufacturing facilities and an R&D laboratory for non-communicable diseases over the next five year…
Article
Global Expansion Shapes Drug Oversight
Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.
Few FDA officials discuss pharmaceutical regulation these days without …
Article
Remote Monitoring and Big Data Advance Upstream Automation
Automating these activities would not only help reduce laboratory resource constraints and improve data integrity, but enable the incorporation of more advanced feed strategies involving PAT and produ…
Article
Eliminating Residual Impurities Starts with a Strategic Plan
Leachables, meanwhile, are typically controlled in a risk-based fashion with high-risk materials assessed in laboratory studies, he notes. “A common basis for the establishment of risk factors is an i…
Article
Gene Therapies Push Viral Vector Production
“Scale-out of these systems result in more laboratory handlings and, subsequently, a higher failure rate due to contaminations,” Touw says.
“This can be prevented by implementing a novel fixed…
Article
Flexible Facilities for Viral Vector Manufacturing
The 3220-ft2 facility will use a good laboratory practice (GLP) viral vector FlexFactory manufacturing platform. Cytiva and UMMS said that the new capacity would help to alleviate the bottleneck of ve…