Search results for " production"
Article
Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
Optimization of each phase in a chromatographic cycle has a positive impact on productivity.
By Anna Grönberg
An important area of focus for the biopharma industry is the elucidation and dev…
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Re-use of Protein A Resin: Fouling and Economics
In a typical platform process for production of mAb therapeutics, approximately 80% of the total process costs are for the steps following fermentation, with up to 60% of the downstream costs coming f…
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FDA Approves First Biosimilar
…e detected throughout the head-to-head PIONEER study, immunogenicity issues can be introduced at the production level, a fact that is not lost on FDA, which pointed out in its written announcement th…
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Optimizing Resin Performance with Disposable Chromatography Solutions
The chromatography system is a long-term commitment to make, whereas a column is a consumable that is disposed after the production campaign is over and the customer can decide if they want to continu…
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Biopharma Manufacturers Respond to Ebola Crisis
Vaccine industry executives and biotech innovators joined the discussion about conducting effective and ethical clinical trials and ramping up production of promising vaccines and therapies. A main ai…
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Brazil Emerges as Global Biopharm Collaborator
The country is eying production and innovation, relying on the key support of the government. According to industry associations, biopharmaceutical innovation in Brazil will increase in the future as …
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2014 Manufacturing Trends and Outlook
Less than 3% reported a drop in production. Only 8.1% said their companies decreased spending for biopharmaceutical equipment and services in 2013 compared to 2012; 37.8% reported increased spending; …
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Digitalization: The Route to Biopharma 4.0
Digitalization in process development
For any production process, there are two key attributes, namely scientific knowledge and technical know-how. Scientific knowledge comprises process developme…
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Regulatory Requirements for Safe and Efficient Biologic Drug Development
STEVE
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Steven Lynn, Executive Vice-President, Pharmaceuticals, Regulatory Compliance Associates, shares insight into regulatory require…
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Emerging Therapies Test Existing Bioanalytical Methods
The time upfront in production and characterization of high-quality reagents will result in reduced cost and timelines for the program. Experiments to develop the methods should be carefully thought t…