Search results for " production" in Articles / App Notes
Article
Reconciling Sensor Communication Gaps
By Angelo DePalma, Ph.D.
Process analytical technology (PAT), quality by design, and individual company- or process-centric quality initiatives are driving the development of bioprocess sensors …
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) u…
Article
Modeling Bioreactor Performance
Doing so is particularly interesting for scale-up purposes in early development to understand how to scale certain scale-dependent parameters to large-scale production bioreactors, but also when movin…
Article
Framing Biopharma Success in 2016
This shift in production requirements--combined with lower profit margins for former blockbuster brand drugs now prescribed as lower-cost generic drugs--has implications for drug development and manuf…
Article
DoE Provides Benefits, but Preparation Is Necessary
In addition, Yang notes that the API material used in DoE studies comes from one or possibly a few selected primary production lots that are not necessarily completely representative of later producti…
Article
Design of Experiments for Analytical Method Development and Validation
Design of experiment is a powerful development tool for method characterization and method validation.
Design of experiments (DOE) is a well-proven characterization approach within product…
Article
Predicting Progress in Protein Aggregation
In silico analysis and the evaluation of formulability, aided by new analytical tools such as hydrogen deuterium exchange mass spectrometry (HDX MS), are enabling the improved design, production, and …
Article
Navigating Emerging Markets: Middle East and North Africa
Cytiva recently opened their new headquarters in Dubai Internet City, as well as a production facility in Saudi Arabia to manufacture diagnostic imaging systems.
Creation of ‘free zones’ for fo…
Article
Bracing for a Future Wave of Advanced Therapies
With the help of recent investor interest, progression of advanced therapy medicinal products (ATMPs) in the clinical space continues to move forward. Buoyed by the regulatory approval of sever…
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Insights and Strategies for Successful Development of Scalable AAV Processes: Part 2 of 2
Topics covered include:
1:00 – The upstream approach for AAV production, such as finding the balance between different parameters in the design of experiments to create a robust production proc…