Search results for " Downstream PD" in Articles / App Notes
Article
Announcing ÄKTA ready™ extended single-use system
ÄKTA ready™ extended system is a single-use liquid chromatography system designed for process scale-up and GMP manufacturing.
The system uses disposable flow paths and prepacked …
Article
How to Use Multiwell Plates With Manual Operation
During process development, aspects like robustness, scalability, and GMP production come into play. FDA initiatives such as quality by design (QbD) put demands on better process understan…
Article
Current Trends in Host Cell Protein Detection for Biologics Manufacturing
Commonly accepted HCP analytical methods, the challenges of HCP assay, and recommendations on what can easily be accomplished in-house and when it may be better to outsource.
Read more here…
Article
See a chromatography modeling software in action
Mechanistic models use computer simulations to decrease the number of experiments you need during process development.
The simulations are based on known physiochemical phenomena involved in ch…
Article
Top Process Development Trends for 2022 and a Look into 2023
FDA approved 37 drugs in 2022, within the normal range for the past decade or so. The European Medicines Agency (EMA) was even more successful—approving a record 55 therapies. More than half of thes…
Article
mRNA: The Messenger - mRNA Synthesis
Explore the mRNA universe with Cytiva.
Join us for part 3 of mRNA: the messenger, where we discuss key considerations for the synthesis of RNA molecules, including optimizing the…
Article
Capture of Bispecific Antibodies and Removal of Product-Related Impurities
The biotherapeutics pipeline is becoming increasingly diverse as antibody variants such as bispecifics, conjugates, and fragments move through preclinical stages to commercial manufacturin…
Article
Developing a Robust Bioprocess Using Mechanistic Models
The safety and efficacy of a biopharmaceutical drug are of the highest priority. Therefore, manufacturers have to design, implement and maintain measures to ensure that the bioprocess con…
Article
Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
Spivey and Lane
Click here to view more Q&As >>
Analytic considerations for upstream processing – covering Process Analytic Technology (PAT), time-savings versus off-line ana…
Article
In silico Approaches towards Automated Biomanufacturing
The goal of manufacturing is to control and maintain a commercial process capable of consistently producing a drug of the highest quality and safety. As part of manufacturing science and t…