Search results for " preparative" in Articles / App Notes
Article
State of Quality and Compliance in the Biopharmaceutical Industry
Have FDA initiatives improved manufacturing quality?
The late 1990s and early 2000s witnessed a slew of enforcement actions by FDA that included multiple Form 483 observations, warning le…
Article
Sterilization Trends for Single-Use Consumables
Single-use (SU) technologies increasingly find use today at all phases of the drug development cycle from preclinical to commercial manufacturing. As the biopharmaceutical market continues to …
Article
Downstream Process Developers: What are Your Antibody Processing Challenges?
Process developers, we want to hear from you! We're asking PD scientists to tell us about their biggest challenges developing downstream processes for mAbs and their variants.
Take this …
Article
From Bottlenecks to Breakthroughs: Mastering Buffer Management
Unlock innovation in manufacturing by optimizing your buffer production.
Agenda
- Options to intensify buffer preparation from using pre-made buffers or buffer concentrates to impl…
Article
A Closer Look at Affinity Ligands
Importantly, and unlike other modes of preparative chromatography, binding of antibody to Protein A affinity ligand is not sensitive to either cell free culture media pH or its osmolality so there is …
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…
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Emerging biopharma: progressing a biologic drug to market
There are many pitfalls in the road to developing and bringing a new therapy to market. Understanding some of these areas and being prepared to make the right decisions at the right ti…
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Pandemic Alters Policies and Practices for Drug Development and Regulation
By Jill Wechsler
The need for medicines to combat COVID-19 has impacted the way regulatory agencies carry out their operations.
Drug development and regulati…
Article
Using Digital Twins to Model Process Chromatography
Digital twins in scale up and tech transfer
BioPharm: How are digital twins used in process development?
Whitelock (GoSilico): All mechanistic models describing preparative chromatography ha…
Article
Track-and-Trace Progress Benefits Supply-Chain Security Efforts
By Agnes Shanley
The industry has made great strides in implementing serialization technologies, while technology developers are enabling more open access to real-time transportation data.
S…