Search results for "qbd" in Articles / App Notes

Article Bioburden Control in the Biopharmaceutical Industry
Protecting against microbiological contamination over the whole manufacturing process grows increasingly important. By Mostafa Eissa The biopharmaceutical industry has witn…

Article 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,…

Article Best Practices for Data Integrity
Best Practices for Data Integrity Optimize practices and meet requirements using electronic data integrity systems. By Jennifer Markarian Maintainin…

Article Process Chromatography: Continuous Optimization
Improved resin chemistries and customized separation solutions are enabling more efficient separations. By Cynthia A. Challener Cell-culture and fermentation are high-…

Article Automated In-Line Buffer Preparation from Ready-Made Stock Solutions in a mAb Process Step
Buffer preparation is both time-and space-consuming and can easily become a challenge in biomanufacturing. This application note describes a lean approach to buffer preparation by implementing in-li…

Article Contract Manufacturing Through the Years
Contract Manufacturing Through the YearsHow has the bio/pharmaceutical contract manufacturing industry evolved over the years and what does the future hoHow has the bio/pharmaceutical contract ma…

Article Column Tips for Successful SEC-MALS
Do you identify molecules using MALS, maybe in combination with size exclusion chromatography (SEC)? We have gathered Column Tips for Successful SEC-MALS in a blog post. Tap into these column …

Article Managing Risk in Biomanufacturing
We simply cannot avoid all risks and the stakes are high in the biopharmaceutical industry. With patients’ lives dependent on a continuous supply of high-quality drugs and vaccines, it is essential …

Article Managing Residual Impurities During Downstream Processing
Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures. By Cynthia A. Challener Manufacture of protein and other biologic drug substances via …

Article Fusion Proteins Pose Manufacturability Challenges
The unique structures of fusion proteins lead to expression, heterogeneity, and stability issues. By Cynthia A. Challener Fusion proteins are engineered proteins that contain domains from di…

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