Search results for " characterization" in Articles / App Notes
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
FDA, Memorandum: Points to Consider in Characterization of Cell Lines Used to Produce Biologics (Rockville, MD, Jul. 12, 1993).
11. FDA, Memorandum: Points to Consider in the Manufactu…
Article
Platform Approach Speeds Process Development
In this context, in-depth hardware characterization is crucial for successful scale-up, scale-down, and global site-to-site transfers. Sophisticated tools, such as computational fluid dynamics, enable…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
In addition, ligand-binding assays enable the characterization of the potency of different biosimilars and provide crucial information on the affinity (dissociation rate constant, KD) and selectivity …
Article
Setting Standards for Biotech Therapeutics in India
While IPC has a laboratory for characterization of reference standards related to pharmaceutical products, it is in the process of creating a state-of-the-art laboratory for biotech products. At prese…
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Discovering the unknown: How does in silico process development change PD scientists’ work?
This is a huge benefit, for example, for process characterization in late-stage PD. Due to the mechanistic nature of the models, it's even possible to extrapolate from the space investigated during mo…
Article
Right the First Time: Bioreactor Scale and Design Translation
Identifying the boundaries of a design space for a robust process is difficult due to the extensive characterization data needed and the diversity of single use bioreactor design.
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On-demand webinar: Balancing innovation, speed, and robustness to improve efficiency in upstream process development
Watch it now, on demand! We'll cover strategies like cell line development, media development, and raw material characterization to help you make your process more efficient.
Sign up and view th…
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What’s in your media? How costly is variability of cell culture media to your manufacturing process?
Megan Manzano: How does Cytiva manage variability in their products?
Christopher Woolstenhulme: We have a robust raw material characterization program that we have been implementing w…
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Join DiPIA 2022
Don’t miss out on latest applications and developments in biophysical characterization, join our two half-days conference where researchers will present their work using surface plasmon r…
Article
Quality by design in biotherapeutics purification white paper
Learn how understanding and addressing variability sources can help you develop robust chromatography processes. The principles and methodologies of biopharmaceutical manufacturing are well …