Search results for " biopharma"
Article
Drug Quality Key to Innovation and Access
FDA plans to advance initiatives for ensuring reliable production of drugs and biologics in 2017.
By Jill Wechsler
Amidst multiple challenges to the structure and governance of the US health…
Article
Advancing Single-Use Technology Through Collaboration
By Cheryl Zigrand
The use of disposable, single-use components within the biopharmaceutical manufacturing process is not a new phenomenon. Silicone tubing, capsule filters, tissue culture flasks, …
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Innovation vs. Capacity: How CMOs Compete
Perhaps the biggest is the reduced propensity of global bio/pharma companies to outsource manufacture of their newest products, especially biopharmaceuticals. New product approvals earned by global bi…
Article
Process Chromatography Selection for Downstream Processing Applications
By Caroline Hroncich
Process chromatography has changed significantly since it was first introduced to the biopharmaceutical industry. Important factors such as column design, resin development, a…
Article
Analysis of Glycosylation in Biosimilars
A step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development.
The structures of protein drugs such as monoclonal antibodies are mad…
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Design and Qualification of Single-Use Systems
Martin
Single-use technologies (SUT) have made significant inroads in biopharmaceutical and vaccine manufacturing. Greater adoption in the years to come can be anticipated, given their broad use i…
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Biosimilars: Making the Switch Comes with Challenges
Market trends
Biosimilar versions of granulocyte-colony stimulating factor (G-SCF) have now gained a market share of more than 50%, Carol Lynch, global head of Sandoz Biopharmaceuticals said durin…
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A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
Bioprocessing equipment and materials, as well as technical discussions about process development, were in prominent positions at the INTERPHEX 2016 trade show, held in New York in late April. Rita …
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Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
By Peter Genest, John Joseph
The benefits of adopting single-use technologies in the production of biopharmaceuticals, such as lower capital investment and increased flexibility, are now well docu…
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Vaccine Development Faces Urgency and Challenges
Global outbreaks energize vaccine R&D and drive production modernization.
By Jill Wechsler
The Ebola outbreak in 2015 and the current stampede to develop a new vaccine to combat the Zika vir…