Search results for " cmos"
Article
Being Thorough When Transferring Technology
Communication and taking the time to develop the process are key to successful transfer and scale up of biologics.
By Susan Haigney
Editor's note: The following is an extended version of the…
Article
Reporting Quality Metrics to FDA
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.
By Siegfried Schmitt
Q: We are a contract manufacturing organization (CMO), sp…
Article
Q&As with Industry Leaders
… at Cytiva
The Evolution of the Role of CMOs in Bioprocessing
Eric Langer, President and Managing Partner at BioPla…
Article
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…
Article
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…
Article
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…
Article
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.
…
Article
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…
Article
The Challenge of Disruptive Technologies in Bioprocessing
The Challenge of Disruptive Technologies in BioprocessingIncreasing demand for biologics is driving the need for innovation in bioprocessing.
Jul 01, 2018
Increasing demand for biologics is drivin…
Article
Applying GMPs in Stages of Development
Applying GMPs in Stages of Development
Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety, …