Search results for " opportunity"
Article
Innovation vs. Capacity: How CMOs Compete
The strategies of an innovation-driven CMO may be different than a capacity-driven CMO.
By Jim Miller
While industry participants and observers talk about the “CMO industry,” they know that …
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
The opportunity lies in improvements that simplify processes and make them more reliable and/or more economic. The demonstration of comparability does not necessarily mean that the quality attributes …
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The Bullish Outlook for Biosimilars
Despite broad recognition that biosimilars may offer badly needed financial relief, certain markets are better positioned to capitalize on this opportunity than others. The global evolution of regulat…
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Healthcare Reform in China
Challenges abound
As China’s healthcare reform program enters its second phase, foreign players are now given more room to take advantage of this opportunity. The State Council has announced that …
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
These full-scale studies also provide the opportunity to confirm the suitability of planned sampling plans and acceptance criteria for process performance qualification (PPQ).
The continuum of cri…
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Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
Sterility must be assured for all biologic drug products. Terminal sterilization achieved via treatment with heat, radiation, or certain chemicals (vaporous hydrogen peroxide, vaporous peracet…
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Next Generation Process Chromatography
We really are at the start of the development journey here and that means there is so much opportunity for future improvement—both for mAbs and other biological targets. Just like single-use bioreacto…
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Science Focus Fuels Successful Process Development for Startups
There is no opportunity at that time for further process optimization, so it is important to be thoughtful about process development early on, according to Sharei.
Lastly, the quantity of effort r…
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A Look at the Affinity Chromatography Landscape
“Increasing binding capacities while retaining unique selectivity continues to be a development opportunity for resin manufacturers,” he adds. There is also a continual demand to increase the producti…
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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…