Featured Articles
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Continuous Flow Ready
8/17/2022
The benefits of continuous flow manufacturing are significant and numerous and those benefits grow with each technological breakthrough and methodological advance.
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Continuous Flow/Batch Manufacturing Mix
4/8/2022
Many factors can necessitate a mix of continuous flow and batch manufacturing processes, which is often the first step towards multi-step flow processes. Review two examples.
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Enhance Reaction Rates For Anti-Cancer Therapy Manufacture
4/8/2022
Applying flow chemistry techniques allowed for a new route for an experimental anti-cancer therapy which included LED-NMR reaction profiling, quantum yield measurements and Stern-Volmer quenching studies.
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A Better Route For Commercial Manufacture: Improved Yields And Operability
4/8/2022
A new process was needed for the commercial manufacturing of Ceralasertib, an experimental anti-cancer therapy with a challenging molecular structure.
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Validation Accelerated
9/1/2021
The challenge: A major pharma company’s need for scale-up and validation of a cGMP intermediate had been delayed for a while when the US FDA suddenly granted it priority status.
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Commercial Manufacturing In Half The Time
9/1/2021
Due to FDA requirements for commercial manufacturing of regulated (GMP) intermediates, a global company needed a dedicated facility to produce its commercial antibiotic intermediate.
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The Biotech And The CDMO: The Case For An Early Partnership
10/2/2020
Biotech investigators can’t possibly know everything required to move their drug candidate from the lab bench to the marketplace. Accepting that reality is the first step toward finding a strategic partner.
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It Hasn't Been Easy For Pharma To Be Green
10/2/2020
Partnering with a CDMO proficient in green chemistry and manufacturing can help a biotech create the most attractive drug package — one that includes a proven commercialization process minimizing toxic wastes that pose safety concerns or require costly remediation.
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Breaking The Either-Or Paradigm Of CDMO Selection
8/13/2020
Choosing a contract development and manufacturing organization (CDMO) often requires “either-or” tradeoffs that divide the candidate companies into polarities of size, location and services offered.
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Rapid Change Is Everywhere In The Biotech Industry. Meaningful Innovation Is Not.
8/13/2020
CDMOs face the challenge of integrating novel technologies to deliver cost-effective innovation to the market. How a CDMO responds to the unexpected can determine the success or failure of a project.