Search results for " quality" in Articles / App Notes
Article
High-concentration monoclonal antibody drugs: manufacturing challenges
Solutions that maintain quality, maximize process yield and product recovery are available and can be introduced to adapt an existing manufacturing platform to the new process requirements.
Downloa…
Article
A risk based approach to sterile filtration
Drug quality cannot be assured only by finished-product testing. Process validation is required to establish scientific evidence that a process is capable of delivering an effective and safe …
Article
Host cell protein quantitation using ELISA
…g Aquamax 4000 Microplater Washer (Molecular Devices) enables fast results without compromising data quality.
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Article
Expanding the Emerging Therapeutic Horizon
Despite the successes that have already been achieved with emerging therapy development and manufacturing, companies are still facing numerous challenges. Aspects such as demand for accelerate…
Article
Process Development and Control for New Modalities
Therefore, failures in quality attributes are typically found post-production after testing is completed.
Supply chain constraints on critical raw materials in the form of lead times of months to y…
Article
How to Use Multiwell Plates With Manual Operation
FDA initiatives such as quality by design (QbD) put demands on better process understanding. High-throughput tools like PreDictor™ plates prefilled with chromatography resins make it possible to explo…
Article
Report from the 12th Plasma Product Biotechnology Forum
Since the first meeting in 1999, the PPB forum has established itself as the key international forum for the plasma manufacturing industry – read our report for the highlights of the 2022 conference…
Article
Good Modeling Practice
But how can we mitigate this risk, improve the model’s quality, and reduce the time we need for model calibration at the same time?
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Article
Designing a 1.5 L Bench-Scale Model of a Perfusion Process
Establishing an appropriate model allows for higher throughput during simultaneous operation and monitoring of several cultures at different process conditions. In this article, we discus…
Article
Current Techniques and Challenges Presented in Scaling Between Bioreactors
These tools require high quality characterization data of the use bioreactors. Stainless steel bioreactors merge with the described tools which may be a challenge for the upcoming years. However, when…