Search results for " industry" in Articles / App Notes
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Guidance for industry. Points to consider in the manufacture and testing of monoclonal antibody products for human use. Rockville, MD; 1997.
5. Schnerman MA, Sunday BR, Kozlowski S, Webber K, Gazz…
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The Lifecycle Change of Process Validation and Analytical Testing
As the pharmaceutical industry transitions to the emerging markets, where reduced pricing structures and localized manufacture are expected, the implementation of these guidelines, in parallel with gr…
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Evaluating the Use of Continuous Chromatography
As the biopharmaceutical industry strives to demonstrate, continuous manufacturing offers the benefits of higher productivity and better product quality than traditional batch manufacturing. In additi…
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Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
Variability challenges
“Sterile manufacturing of live viral vectors used to be the ultimate challenge in the biopharmaceutical industry,” Heller continues. Today, however, the variable nature of vi…
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Top challenges in recombinant protein purification process development
In the industry, we're seeing recombinant proteins more often, right? And we're seeing some common challenges of course arise when it comes to exploring these more innovative and potentially lifesavin…
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Report from the 12th Plasma Product Biotechnology Forum
After a prolonged break due to the Covid-19 pandemic, there was a great appetite to meet again and discuss the latest developments of importance to the industry. The 12th PPB conference, held in Novem…
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Top Process Development Trends for 2021 and a Look into 2022
Nonetheless, it was evident in a roundtable discussion of industry experts that this field is full of opportunities to treat both rare and common diseases, and it will continue to evolve and advance w…
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Cell-free Expression Systems Pose Cell Culture Alternative
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Innovative Chromatography Resins Can Improve Purity and Quality
…velop and bring new bio-molecules to the market, and resins will keep on being a cornerstone in this industry for decades to come,” says Ihre.
Meanwhile, manufacturers working on new targets, whe…
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Common Challenges in Cross-Functional Process Development
James is a leading industry consultant with broad chemistry, manufacturing, and controls experience in product development and quality that encompasses early process development to commercial operatio…