Search results for "qbd"
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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…
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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 …
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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 …
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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 …
Poster
Strategies for optimized cell culture media: Effectively using design space to influence product quality
Effective biopharmaceutical production is achieved in part through target-specific, quality-optimized cell culture media. Balancing the many individual media components required to achieve high tite…
Poster
Case Study: Improve Process Economy by Cycling of Prepacked Chromatography Columns
The use of disposable technologies in downstream processing has increased significantly over the last years, as they reduce the need for time-consuming cleaning and cleaning validation operations as…
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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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Being Thorough When Transferring Technology
Communication and taking the time to develop the process are key to successful transfer and scale up of biologics.
By Susan Haigney
Editor's note: The following is an extended version of the…
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Witnessing Major Growth in Next-Generation Antibodies
Including next-gen antibodies in pharma pipelines is considered essential for future success.
By Cynthia A. Challener
Next-generation antibodies are designed to be more specific and are ofte…
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Sources of Bioburden You Might Have Missed
A problem with traditional mAb manufacturing is that there are so many potential entry points for microbial contamination. There are, however, ways to shut the door on contamination.
The risk …