Search results for " drug"
Article
The Importance of Partnering for Bioanalytical Studies
By Feliza Mirasol
Bioanalytical studies are an important aspect in biologic drug development because data from these studies are needed to define the characteristics of potential new biologic …
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Science Focus Fuels Successful Process Development for Startups
They lack access to revenue streams from existing drug sales to fund their process development efforts, so money must be raised, which requires convincing investors that the ideas they are developing …
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Witnessing Major Growth in Next-Generation Antibodies
The global market for next-generation antibodies, including antibody drug conjugates (ADCs), engineered antibodies, bispecific antibodies, antibody fragments, antibody-like proteins and biosimilar ant…
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Aseptic Processing: Keeping it Safe
Although states currently oversee the activities of compounding pharmacies, FDA released new draft guidance documents in February 2015 seeking to exert more regulatory control over drugs produced by s…
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Robust Optimization, Simulation, and Effective Design Space
Developing product knowledge and process understanding is at the heart of modern drug development. Establishing a clear line of sight between critical quality attributes (CQAs), process parameters, an…
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Driving Improved Access to Biosimilars
…t safety with innovation, the spring and summer of 2019 brought several US congressional hearings on drug prices and greater focus on biosimilars, including an FDA meeting devoted exclusively to the …
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Biopharma Says It Has an Evolution in New Technologies and Processes
Yu, deputy director of the Office of Pharmaceutical Quality in FDA’s Center for Drug Evaluation and Research, talked about the future of pharmaceutical quality—and the challenges of achieving quality …
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Process Chromatography: Continuous Optimization
A combination of chromatography steps using different resin chemistries is used to purify the biologic drug substance to an acceptable level. The number and types of chromatography steps depend on the…
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Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Compared to traditional small-molecule drugs, their structures are complex, and they may assert their effects by binding to more than one target molecule. To date, the majority of monoclonal antibodie…
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The Bullish Outlook for Biosimilars
…antial growth of biologics in recent years and the number of expected patent expiries for originator drugs. Biologics have become a significant part of the global drug market with sales growing from …