Search results for " drug" in Articles / App Notes
Article
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…
Article
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…
Article
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…
Article
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FDA Releases Draft Guidance on Emerging Manufacturing Technology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 …
Article
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…
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USP Publishes Monoclonal Antibody Guidelines
Morris, PhD
BioPharm International
Volume 3, Issue 28
As FDA gears up towards approving biosimilar drugs in the United States, it is unquestionable that the role of biologics has rapidly expa…
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Application of Quality by Design to Viral Safety
Using this approach, products are developed with a thorough understanding of how the raw materials and manufacturing processes impact the eventual clinical performance of the final drug product. QbD f…