Search results for "quality" in Articles / App Notes
Article
Tools and Solutions for Separation of Charged mAb Variants
To attain regulatory approval, a comparable quality to the reference product in terms of efficacy, purity, and safety should be demonstrated. Biomolecules, however, exhibit high structural complexity …
Article
Driving Change in Biomanufacturing
The new technology must be fully understood, all regulatory requirements fulfilled, the quality of the product output secured, and a thorough risk mitigation conducted.
The large buffer volumes …
Article
Reducing Cross-Contamination Risks in Process Chromatography
“Users of disposable technologies should ensure that their suppliers have adequate expertise and controls in place to ensure quality, timely supply, and documentation support of the systems they provi…
Article
Platform Technologies Improve Protein Expression
Improving yield has always been and will continue to be one of the key drivers for a technology platform to be successful, explains Havenga, although clearly agility, product quality, and regulatory a…
Article
Development of Purification for Challenging Fc-Fusion Proteins
Development of Purification for Challenging Fc-Fusion Proteins
This study outlines methods for an alternative protein-polishing process for challenging proteins.
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Article
Modeling and Miniaturization: Key Topics at Successful HTPD Conference
…advances in high-throughput automated minibioreactor systems improved development timelines and the quality of scale-down models.
However, conference attendees said in a survey that the presentat…
Article
The New World of Biopharmaceutical Manufacturing
Industry experts discuss the single-use revolution and changes to upstream and downstream processing equipment.
By Jennifer Markarian
…
Article
Witnessing Major Growth in Next-Generation Antibodies
… subunits with novel formats, according to John Joly, senior director of analytical development and quality control with Genentech. He adds that formats have been engineered to engage T cells directl…
Article
Automating Bioprocesses
Automation of stainless-steel systems and single-use systems differs in complexity.
By Jennifer Markarian
Both upstream and downstream biopharmaceutical processes have conventionally used st…
Article
Improving Process-Scale Chromatography
… buffer variability can be compensated for in line through adjustment of relative volumes to ensure quality control of the final buffer formulation.”
Pall, meanwhile, has developed an in-line conc…