Search results for "downstream"
Article
2019 HTPD Conference Is Announced. What Happened Last Time?
HTPD 2019 will cover process development spanning upstream through downstream processing for both mAbs, Ab-like molecules as well as novel biomolecules. Sessions will also include integrated P…
Article
Case Study: Process for Production of Oncolytic Adenovirus
The case study describes a process from upstream cell culture to downstream purification, using scalable modern tools and technologies.
Read the case study on "Process for Production of Oncolytic…
Article
Prepare for an FDA Bioburden Inspection
Click here to read the article >>
Not sure how to best approach a bioburden problem when an FDA inspection is imminent? Anastasia Lolas, former FDA Biologics License Application (BLA) revi…
Poster
A Scalable Adenovirus Production Process
To meet these needs, a process for adenovirus production, from upstream cell culture to downstream purification, using modern tools and technologies was developed.
The novel process is easily sc…
Article
Challenges in Cell Harvesting Prompt Enhancements
Challenges in Cell Harvesting Prompt Enhancements
Higher cell titers and cell densities have posed a challenge to cell harvesting, a crucial step in biologics manufacturing.
By Feliza Mi…
Article
Automation Trend in Fill/Finish Reduces Contamination Risk
The rise of costly biologics over the past 20 years, however, has put greater pressure on downstream fill/finish operations to ensure that quality, safety, and cost efficiency are not compromised at t…
Article
Putting Viral Clearance Capabilities to the Test
Viral clearance studies assess the capability of a downstream process to remove or inactivate potential contaminants and are based on a scale-down model of a biopharmaceutical production process. The …
Article
Flow Accuracy and Gradient Performance of ÄKTA pilot 600 Chromatography System
Accurate flow is important for your chromatography step to provide reproducible results at different scales. A comparable flow accuracy between scales can facilitate scaling of your methods.
In…
Article
Evaluation of Performance of a Disposable mAb Affinity Chromatography Column Used Over Multiple Process Cycles
Presanitized and prequalified disposable chromatography columns are widely used to save time in downstream processes. However, reuse of such columns could positively impact process economy. This app…
Article
Tools and Solutions for Separation of Charged mAb Variants
A biosimilar is an almost identical version of an originator product. To attain regulatory approval, a comparable quality to the reference product in terms of efficacy, purity, and safety should be …