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Process development, QC, QA & GMP manufacturing

Icosagen is a mammalian protein drug discovery, development, and manufacturing expert, with uniquely combined CRO and CDMO capabilities under one roof, to offer fully integrated CRDMO services.

Icosagen built its own, 1400 m² GMP facility, that is equipped with state-of-the-art 50L, 200L and 1000L single-use bioreactors, along with GMP cell banking, seed train, upstream and downstream suites, as well as QC and QA to produce liquid GMP bulk drug substance. 

Attaching it to our long-established R&D facility, our clients can now seamlessly transition their antibody and recombinant protein drug candidates from multi-parallel research concepts into preclinical stage, and EMA/FDA-approved phase I/II clinical trials.

Process development, QC, QA & GMP manufacturing

PRE-CLINICAL
TO CLINICAL
MANUFACTURING

PRE-CLINICAL TO CLINICAL MANUFACTURING

With 25 years of mammalian cell culture experience, we specialize in optimizing and manufacturing protein drug candidates. Our pre-clinical CRO expertise includes antigen production, antibody discovery, protein engineering, humanization, developability assessment, and comprehensive protein analytics, culminating in up to 50L non-GMP manufacturing. By combining CRO skillset with CDMO capabilities, we transform into a distinctive mammalian protein CRDMO.

INTEGRATED
R&D AND GMP
FACILITY

INTEGRATED R&D AND GMP FACILITY

Our co-located cell line development, process development, analytical, and GMP manufacturing teams guarantee ground-up design for industrial manufacturability, while eliminating technology transfer risks. These unique integrated capabilities accelerate our clients’ molecules’ smooth and efficient progress through its entire CMC journey.

QUALITY
ASSURANCE

QUALITY ASSURANCE

We prioritize quality at every stage of the development process, ensuring compliance with regulatory requirements and European industry standards. Our in-house QA departments helps our clients to fulfill CMC requirements and documentation for both the EMA and FDA.

Upstream process development

Initial upstream process (USP) parameters for the IcoCell® lead clone are established during cell line development process in the Ambr®15 system. Key parameters including pH, dissolved oxygen and CO2, metabolite and nutrient levels are closely monitored.

Optimal USP parameters are finalized in the Ambr®250 system. Critical process parameters and conditions such as pH, dissolved oxygen, agitation feeding and gassing strategy are carefully adjusted, and resulting key metrics, including cell culture density and viability, product titers and desired quality attributes are optimized. With this scalable, multi-parallel single-use benchtop bioreactor platform, we establish optimal USP parameters for subsequent large-scale GMP manufacturing. 

Process development, QC, QA & GMP manufacturing

Downstream process development

In downstream process development, an efficient purification process is established for the highly expressed drug substance, be it a platform-based antibody/Fc molecule or a de novo purification for a recombinant protein. Sequential chromatography and filtration steps, including virus removal/inactivation measures are combined to minimize impurities, downstream processing time and costs of goods, while optimizing product quality and yield. 
Finally, confirmation runs in fully controlled bioreactors, in several liters scale, prove the establishment of a scalable, rapid, robust and efficient upstream and downstream process as foundation for 1000L scale clinical GMP material production. 
Process development, QC, QA & GMP manufacturing

Why work with Icosagen for process development and GMP manufacturing?

ANALYTICAL &
FORMULATION
DEVELOPMENT FOR
DRUG SUBSTANCE

ANALYTICAL METHODS & FORMULATION DEVELOPMENT FOR DRUG SUBSTANCE STABILITY DATA

By combining our unique pre-clinical and clinical CRDMO concept with individual molecule attributes, we raise crucial analytical, formulation, and drug substance stability data quickly and ahead of time, to de-risk and speed up our clients’ CMC programs.

WE ASSURE
REQULATORY
COMPLIANCE

WE ASSURE REGULATORY COMPLIANCE

Your program is supported by an experienced team of scientists, engineers, and quality professionals, together with manufacturing and regulatory experts. With state-of-the-art analytical development capabilities, crucial for rapid method establishment, and precise molecule characterization, we meet stringent regulatory standards, ensuring early and thorough understanding of your molecule.

MAXIMIZING
QUALITY &
MINIMIZING
TIMELINES

MAXIMIZING QUALITY & MINIMIZING TIMELINES

Icosagen has the equipment, personnel and experience, combining both scientific ingenuity, and innovative technology platforms to complete your project from R&D till GMP with minimized timelines and maximized quality.

GMP manufacturing overview

Upstream process

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Downstream process

Services_icosagen_GMP_workflow_Downstream_Process_Development
Stable CHO Cell Line Development Service_Icosaen CRDMO_Dr.Oliver Schub portrait

For inquiries about cell line development, process development or GMP manufacturing,
contact Dr. Oliver Schub

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