Search results for " Downstream PD"
Article
2019 HTPD Conference Is Announced. What Happened Last Time?
The 5th international conference devoted to high-throughput process development (HTPD) and smart PD, will take place November 4-7, 2019 in Porto, Portugal.
HTPD 2019 will cover process devel…
Article
Case Study: Process for Production of Oncolytic Adenovirus
The promising results from clinical studies on the use of viral vectors to address important medical needs have spurred interest in developing scalable and cost-efficient manufacturing processes. Here…
Article
Prepare for an FDA Bioburden Inspection
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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
The promising results from clinical studies on the use of viral vectors to address important medical needs have spurred interest in developing scalable and cost-efficient manufacturing processes. To…
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
Aseptic fill/finish is crucial in biopharma manufacturing and is optimized through automated technology.
By Feliza Mirasol
Aseptic filling is a crucial process in biopharmaceutical …
Article
Putting Viral Clearance Capabilities to the Test
Process understanding and careful assessment of risks are essential in developing viral clearance programs.
By Rita C. Peters
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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 …