Search results for " system"
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
The riboflavin testing used for spray device qualification in CIP systems also helps in identifying areas that must be sampled due to limited coverage.
Risk-based surface sampling locations an…
Article
Development of Purification for Challenging Fc-Fusion Proteins
Buffers were formulated in an acetate buffer system of pH 4.0 to 5.5 with 0 to 250 mM sodium chloride (NaCl) concentration. The filter plate was shaken between stages at 1200 revolutions per minute (R…
Article
Modeling and Miniaturization: Key Topics at Successful HTPD Conference
Ottens presented work performed at TU Delft with a novel microfluidic system on a lab chip. Integration of parallel micromixers and microcolumns (50-70 nL scale) on the chip allowed solid-phase micro-…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
Mammalian cells meet these criteria quite efficiently by virtue of their post-translation modification system, and this has made them a dominant production system for the biopharmaceutical industry. M…
Article
N-Glycan Analysis of Biotherapeutic Proteins
The latter name uses “Oxford” nomenclature (10), which has an associated system for generating structural diagrams of glycans. The other main system for “cartoons” of glycan structures is from the Con…
Article
Managing Residual Impurities During Downstream Processing
“With the diversification of expression systems, the immunoassay approach may become increasingly difficult to follow, and regulation around alternative methods could become necessary,” she asserts.
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Article
Ensuring Sterility in Small-Scale Production
There also needs to be a facility maintenance program that challenges the appropriateness of the air handling system. Establishing a periodic maintenance program for your high-efficiency particulate a…
Poster
Validation of the Production of Influenza Virus
A 2 L process, developed using the predecessor WAVE Bioreactor™ 20/50 system, was used as a starting point. Compared with WAVE Bioreactor 20/50, the successor ReadyToProcess WAVE 25 system allows usin…
Article
Real Time Continuous Microbiological Monitoring
A real-time laser-induced fluorescence (LIF) system, however, continuously monitors viable (microbial) and non-viable particles in real time and provides both total particulate and viable counts. LIF …
Article
Modeling Bioreactor Performance
On a positive note, he points out that as standardization of reactor geometries for single-use systems occurs, the number of reactor geometries that require characterization is decreasing, which is cr…