Search results for " drug"
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What is process development?
Process development activities will vary by your type of biomolecule, as well as the stage of the drug development process you are in – preclinical, early clinical (Phase I/Phase II), or late clinical…
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Chromatography for the Diversified Antibody Pipeline
Eva Helding: The antibodies are one of the largest classes of biomolecules and there are several approved drugs—the first approved drug was in 1986. The antibodies have been there; however, we have al…
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Successfully Moving Regulated Data to the Cloud
But the real benefit is how an expedited submission process can reduce the time it takes to get a new drug to market, which benefits the consumer.
Managing ever-increasing quantities of data
Bec…
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Scaling Up Novel Therapies
At this point, the FDA has approved one directly-administered and two cell-based gene therapies, Marks said, but the Agency has received over 700 investigational new drug (IND) applications in the gen…
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Preclinical Evaluation of Product Related Impurities and Variants
These drugs have become the centerpiece of biotechnology industry and an integral part of modern medicine, evidenced by the annual global expenditure of $1.2 trillion for 2016 (2). These products also…
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Roadmap Leads to Innovative Biomanufacturing Strategies
These companies had the most experience in the direct supply of drug to patients. It was clear from the beginning that the full benefit of the roadmap would eventually only be realized with the partic…
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Fusion Proteins Pose Manufacturability Challenges
Solutions for overcoming these issues are being developed in academia and the pharmaceutical industry by equipment vendors and drug companies alike.
Making proteins ‘druggable’
Many proteins…
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Ensuring Sterility in Small-Scale Production
For these small-scale batches, manufacturers need to adhere to the recommended requirements for control of the environment as defined in FDA’s aseptic processing guidance (1), the Parenteral Drug Asso…
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FDA Releases Draft Guidance on Emerging Manufacturing Technology
…sion questions and proposals about the use of innovative technology to a group within the Center for Drug Evaluation and Research (CDER), entitled the Emerging Technologies Team (ETT).
According …
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Biacore Concentration and Ligand-Binding Analyses
Compared to traditional small-molecule drugs, their structures are complex and they can assert their effects by binding with high specificity to more than one target molecule. During development and i…