Search results for " quality"
Article
CDMOs Driving Emerging Bio/Pharma Success
Without the access to CDMOs, companies would need to invest at least $10 million in facilities and a similar amount on manufacturing, analytical, and quality professionals. It would take at least two …
Article
Putting Viral Clearance Capabilities to the Test
“Virus spike quality can influence the operation of key steps; for example, higher purity virus spikes are required for virus reduction filters to minimize virus induced flux decay and achieve the tar…
Article
FDA Framework Spurs Advanced Therapies
As importantly, she notes that FDA must be aware that some of the well-established manufacturing and quality systems used to support the production of well-established medicinal products may not alway…
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.
…
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 presenta…
Poster
Repurposing Fed-Batch Media and Feeds for Highly Productive CHO Cell Perfusion Processes
High productivities and favorable product quality were also achieved.