Search results for " patients" in Articles / App Notes
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The New World of Biopharmaceutical Manufacturing
Being able to provide consistent information from drug manufacturers to health authorities around the globe will ultimately favor the prompt launch of more medicines to meet the needs of many patients…
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Managing Risk in Biomanufacturing
With patients’ lives dependent on a continuous supply of high-quality drugs and vaccines, it is essential to have consistency within the industry on how to manage risks. Today’s business environment r…
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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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Speed and Flexibility Are Dual Goals for Biopharma Operations
Bioprocessing facilities, equipment, and materials, as well as strategies to improve biopharmaceutical development and manufacturing, were featured at INTERPHEX 2017, held in March in New York City.…
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
The ultimate beneficiary will be patients, who are likely to see reductions in the currently astronomical price of life-saving biologic therapies.
References
1. P.J. Declerk, Expert Opin. Biol…
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Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
Formation of protein aggregates and subvisible particles during the manufacturing of drug products are a major concern due to the potential immunogenicity of protein aggregates in patients (17–22). Th…
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Ensuring the Biological Integrity of Raw Materials
…icant source of contamination, which can lead to false research results and a serious health risk to patients receiving the product.
Contamination of biologic drugs and vaccines by adventitious a…
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Managing Risk in Raw Material Sourcing
Risk management is the key to avoiding batch failures, as well as adverse effects in patients, she explained. IPEC has developed standardized templates and materials to help simplify supplier evaluati…
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Real Time Continuous Microbiological Monitoring
… but could potentially grow as an opportunistic infection under special conditions found in clinical patients.
The development of such instrumentation capable of providing an evaluation of microb…
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Managing Biomanufacturing Capacity Expectations
Capacity for complex therapeutics is becoming increasingly difficult to predict.
By Randi Hernandez
Demand for any given new product is typically only known after significant investments h…