Search results for " guide"
Article
Manufacturing mRNA for research and beyond
This eBook guides you in the practical aspects of setting up an mRNA research laboratory. Get insights on methods, materials, and workflows for mRNA synthesis and scale up.
Explore the mRNA…
Article
Select Prepacked Columns for Your ÄKTA System
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Download selection guide for an overview of prepacked columns from Cytiva to see which ÄKTA protein purification systems can be used with the columns.
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Typical Purification Protocols to Obtain the Right Purity and Yield
Our free digital guide helps you effectively combine the main chromatography techniques to obtain a powerful purification protocol.
Article
Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
A simple failure mode and effect analysis (FMEA) can guide such evaluation and implementation options. Stability studies on these buffer concentrates following International Council for Harmonization …
Article
An Analytical Approach to Biosimilar Drug Development
Providing analytical data on the comparison between a biosimilar and the reference product is a primary consideration in the development of biosimilars.
By Feliza Mirasol
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Avoiding Investigational Failures and Discrepancies
Avoiding Investigational Failures and Discrepancies
Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
By Walt Murray,…
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Cleaning of Dedicated Equipment: Why Validation is Needed
…utical equipment is essential to reduce the risk of product contamination and, as stated in relevant guidelines and as recognized by the pharmaceutical sector, this can be achieved only if the cleani…
Article
Host-Cell Protein Measurement and Control
Regulatory Requirements for HCPs Measurement and Control
According to International Conference on Harmonization (ICH) guidelines Q6B, “For host-cell proteins, a sensitive assay (e.g., immunoassay,…
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Using Quality by Design to Develop Robust Chromatographic Methods
BIPM, JICM 100: Guide to the expression of uncertainty in measurement (GUM), (2008).
8. S.L.R. Ellison, M.Rosslein, and A. Williams (Eds.), ‘’Quantifying Uncertainty in Analytical Measurement,’’ i…
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In silico optimization of AAV full/empty particle separation with AIEX
The separation of adeno-associated virus (AAV) with high yield and purity is an increasingly important challenge. Mechanistic modeling is the tool of choice to find the optimal AIEX chromatogr…