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Project Management - GBI Biomanufacturing

Explore GBI s project management method for keeping CDMO biologics projects on track and on budget in a transparent, proactive manner prioritizing the client.
https://www.gbibio.com/project-management/ - Details - Similar

Regulatory CMC Support - GBI Biomanufacturing

Concerned about regulatory and CMC support for your drug candidate? Learn more about GBI s long experience with IND filings and FDA type II Drug Master Files.
https://www.gbibio.com/regulatory-cmc-support/ - Details - Similar

Quality Control Quality Assurance - GBI Biomanufacturing

Read about GBI s offering of Quality Control and Quality Assurance services for ensuring compliance with specifications for drug substances and drug products.
https://www.gbibio.com/quality-control-quality-assurance/ - Details - Similar

Upstream Processing Cell Culture Development - GBI Biomanufacturing

Explore GBI s offering of robust and reproducible cell culture upstream process development services for producing complex therapeutic protein drug candidates.
https://www.gbibio.com/usp-cell-culture-development/ - Details - Similar

cGMP Cell Banking Services - GBI Biomanufacturing

Read about GBI s full array of cGMP-compliant cell banking services for short- or long-term storage for research or manufacturing including RCB, MCB, and WCB.
https://www.gbibio.com/cgmp-cell-banking-services/ - Details - Similar

Aseptic Fill Finish - GBI Biomanufacturing

Explore GBI s sterile fill finish capabilities and process, including our ISO5 filling suite and details about our regulatory compliance and specialized fills.
https://www.gbibio.com/aseptic-fill-finish/ - Details - Similar

Bioconjugation - GBI Biomanufacturing

GBI has performed over 50 bioconjugation projects involving process development and validation scale-up cGMP manufacturing of multi-gram antibody drugs and others.
https://www.gbibio.com/bioconjugation/ - Details - Similar

DSP Purification Development - GBI Biomanufacturing

Learn more about GBI s proven track record of developing robust, scalable, and cost-effective protein downstream processes across many different biologics.
https://www.gbibio.com/dsp-purification-development/ - Details - Similar

cGMP Clinical Commercial Manufacturing - GBI Biomanufacturing

Learn about GBI s cGMP manufacturing capabilities for drug substances and drug products including monoclonal antibodies, vaccines, and antibody drug conjugates.
https://www.gbibio.com/cgmp-clinical-commercial-manufacturing/ - Details - Similar

Manufacturing Strategy Development - GBI Biomanufacturing

Read about GBI s manufacturing strategy development for process development, scale-up, cGMP manufacturing, through to regulatory filings and related services.
https://www.gbibio.com/manufacturing-strategy-development/ - Details - Similar

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