Search results for " drug" in Articles / App Notes
Article
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…
Article
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Although states currently oversee the activities of compounding pharmacies, FDA released new draft guidance documents in February 2015 seeking to exert more regulatory control over drugs produced by s…
Article
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…
Article
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 …
Article
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 …
Article
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…
Article
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…
Article
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 …
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
The costs of freezing and storing bulk drug substance can be reduced by targeting high concentrations. Concentrations above 250 g/L have been achieved using ultrafiltration at elevated temperatures (1…
Article
A Plastic Pipeline for Commercial Bioprocessing?
The maturation of single-use technologies presents commercial bioprocessing options for small-volume drug products.
By Rita C. Peters
Nejron Photo/Shutterstock.com
…