Search results for "qbd" in Articles / App Notes
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Your Reliable Downstream Bioprocessing. Our Proven AxiChrom Columns
The goal for biopharmaceutical manufacturers is to develop a process that will deliver material for clinical trials quickly and smoothly, achieve success in these trials, and scale up to commercial …
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Platform Approach Speeds Process Development
A modular cell-culture platform demonstrates accelerated process development.
By Harald Bradl, Jan Bechmann, Benedikt Greulich, Markus Michael Mueller, Patrick Schulz, Thomas Wucherpfennig
C…
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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…
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Lessons Learned Accelerate Vaccine Development
Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing.
By Cynthia A. Challener
Vaccine development is a complicated process that can take many yea…
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Developing Cleaning-in-Place Protocols
Cleaning conditions for chromatography media can be screened in a couple of working days using 96-well microtitre plate formats. A study with a Protein A resin illustrates the approach in this appli…
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Innovative Therapies Require Modern Manufacturing Systems
FDA and industry see progress and challenges in bringing cutting-edge medicines to patients.
By Jill Wechsler
FDA set a 19-year record in 2015 in approving more new drugs and biologics, and …
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Framing Biopharma Success in 2016
Corporate restructurings, regulatory initiatives, and biosimilars will shape biopharma development in 2016.
By Rita C. Peters
The US biopharmaceutical industry turned a new page in 2015 when…
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KUBio modular biopharm facility built in Germany, assembled in China
Cytiva is supplying a full biopharmaceutical processing solution, known as a KUBio, to JHL Biotech in Wuhan, China. The sixty-two completed modules that make up the factory have completed the journe…
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Biopharma in 2015: A Year for Approvals and Innovations
Insiders agree that 2015 was a banner year for biopharma. Last year’s new drug approvals reached 51, besting every year since 1950. Twenty approvals (39%) went to biological drugs—up from 35% in 201…
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FDA Releases Draft Guidance on Emerging Manufacturing Technology
By Caroline Hroncich
On Dec. 23, 2015, FDA released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base. The guidance discuss…