Search results for " Biopharm" in Articles / App Notes
Article
How To Execute Successful Data Migrations
Successful migrations require careful planning to meet business needs and maintain data integrity.
By Art Meisler
Data migration is the unglamorous task of a system implementation. …
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Reimagining Affordable Biosimilars
More than 300 active biopharmaceutical product licenses in the market today bear witness to increasing interest in targeted treatments. With an anticipated valuation of over $200 billion by 2022, this…
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ISPE Releases Cleaning Validation Guide
ISPE has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitioners.
The International Society for Pharmaceutical Engin…
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Cytiva Invests $500 Million Over 5 Years to Expand Global Capacity
The investment will include new manufacturing lines and increased automation to deliver additional manufacturing capacity.
On Sept. 13, 2020, Cytiva, announced that it is investing $500 million o…
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Cytiva Introduces the Xcellerex Automated Perfusion System
The APS system comes equipped with filter switching, liquid management, and cell bleed to reduce risk of human error and increase process robustness.
Cytiva announced on Sept. 16, 2020 that it i…
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EMA Confirms Standards for COVID-19 Treatment Evaluations
The agency sent an open letter to European Ombudsman Emily O’Reilly affirming the agency’s intention to apply the same standards to the evaluation of COVID-19 treatments as it does to other medicine…
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Strategizing for Rapid Changeovers in Biologics Manufacturing
Equipment selection matters too
In general, the equipment developed for the biopharmaceutical industry includes built-in functionality—both hardware and software—to make changeovers easier, accord…
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Technology Innovations Improve Process Chromatography Performance
Current challenges
The biopharmaceutical industry continues to face technical and logistical challenges in process chromatography, particularly during scale-up. Although significant work has been …
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Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
Buffers and salts are typically the largest constituents by volume used in the downstream processing steps for manufacturing most biopharmaceutical products. A typical monoclonal antibody (mAb) proces…
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Eliminating Residual Impurities Starts with a Strategic Plan
Numerous risk factors
Residual impurities in biopharmaceutical processes can be traced back to raw materials or can form during upstream or downstream processing steps and upon storage. They can b…