Search results for " CGMP"
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Xcellerex™ X-platform bioreactor live virtual demo
Whether in pilot or cGMP facilities, the modular and application-based approach improves cell culture productivity.
In this virtual event, Ken Clapp will explain how we developed the Xcellerex™ X-p…
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Accelerating an Orphan Therapy to Market
Cytiva scientists worked closely with Roivant Sciences to facilitate tech transfer, and a cGMP manufacturing process was developed. As a result, 400 g of RVT 801 was produced for toxicology studies.
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Akron Bio Will Install a Cytiva FlexFactory to Manufacture Plasmid DNA
“With this partnership, Akron demonstrates its continued commitment to supporting the advancement of cell and gene therapies with cGMP [current good manufacturing practice]-compliant solutions at indu…
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Cytiva Upgrades Massachusetts Contract Biomanufacturing Site with Increased Capacity and Automation Technologies
Cytiva has completed the extensive renovation of its Fast Trak cGMP contract biomanufacturing and process development site in Marlborough, MA, USA.
The upgraded facility is 60,000 square-feet (5…
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Using Software in Process Validation
Nothing should happen that is outside of the rules
for cGMPs.
In a validation system, there is also flexibility, because the user can choose how frequently they would schedule a backup. M…
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Single-Use for Downstream Chromatography: Benefit or Hindrance?
Hindrance or help?
Many disposable chromatography columns meet cGMP and industry standards, and also offer reproducibility, scalability, speed, ease-of-use, and operational safety.
However, chr…
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Development of Purification for Challenging Fc-Fusion Proteins
Consistent performance of flow-through operations was demonstrated in multiple cGMP campaigns at the 2000-L scale.
Introduction
Improvements have been made in mammalian cell …
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Avoiding Investigational Failures and Discrepancies
As referenced in FDA’s Quality Systems Approach to Pharmaceutical CGMP Regulations guidance, an “investigation” refers to the formal procedural process evaluation of a problem resolution (2). The Form…
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Being Thorough When Transferring Technology
Lonza: A mammalian process designed with insufficient appreciation of operability within a cGMP facility and lack of process understanding from the process transferring partner can increase the risk o…
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Advanced Technologies Facilitate Scale-up and Technology Transfer
“Companies will have to consider the quality standards they want to reach and whether modules already constructed to meet cGMP and other industry requirements will better meet their needs,” he adds.
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