Search results for "cmo"
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Being Thorough When Transferring Technology
During tech transfer, methods, skills, technologies, and importantly, knowledge is transferred from the drug developer to another site or group, often a contract manufacturing organization (CMO). It’s…
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Reporting Quality Metrics to FDA
By Siegfried Schmitt
Q: We are a contract manufacturing organization (CMO), specializing in chemical synthesis of APIs. Since the publication of FDA’s draft guidance, Request for Quality Metrics, …
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Q&As with Industry Leaders
…at Cytiva
The Evolution of the Role of CMOs in Bioprocessing
Eric Langer, President and Managing Partner at BioPlan…
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Optimizing your Cell Culture Process to Improve Productivity
The companies that support biopharma’s such as contract manufacturing organizations or CMOs are participating in cell line or media development. We have been working with cultured meat industry, which…
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Current Techniques and Challenges Presented in Scaling Between Bioreactors
Jeanne Linke Northrop: How are they developing that tech transfer and scaling process today? What tools are they using?
Andreas Castan: The organizations which includes CMOs have acquired ela…
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Track-and-Trace Progress Benefits Supply-Chain Security Efforts
By Agnes Shanley
The industry has made great strides in implementing serialization technologies, while technology developers are enabling more open access to real-time transportation data.
S…
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Gene Therapies Push Viral Vector Production
Capacity increases should resolve the supply shortage, which will be followed by the consolidation of CMOs [contract manufacturing organizations] with smaller players being acquired,” Vicaire adds.
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State of the Biopharmaceutical Industry: Lessons from 2018 Survey Data
Most facilities, both developers and CMOs, generally report average costs/gram in the $200–$500/gram range, with these costs still allowing for very healthy markups and profits.
Were there any sur…
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The Challenge of Disruptive Technologies in Bioprocessing
In addition, there is increased focus to expand the role of contract manufacturing organizations (CMOs) to meet market demands for biomanufacturing, Terova explains.
“Higher productivity and hi…
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Applying GMPs in Stages of Development
Working closely with your CMO/CRO to identify an accurate timeline for completion, including the necessary training required for employees, can help expedite the time it takes to complete the change r…