CMC Support and Management
Team specializations:
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Process development
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Process validation
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Drug Substance
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Drug Product
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Product Release and characterisation
Our team of experts is specialized in various critical areas to support your product development, especially for biological products (mAbs, cell and gene therapy products, exosomes... ) We work with biotech companies at various stages of their projects: Starting from early phases to Phase 3 and marketing authorisation application preparation.
Our scope of work:
Global development strategy
Early-stage strategy: process development, clinical batches, stability studies, planning, budget…
Late-stage strategy: comparability, process validation...
CMO/CDMO selection
Using structured frameworks and evaluation tools, assisting in Request for Proposal (RFP) creation and follow-up.
Project management
CMC engineering and technical support
Acting as CMC project manager for our client: process and analytical methods development and /or transfer, production, testing and quality event follow-up
Validation Plan
Providing technical support to clients with in-house labs, offering guidance on upstream and downstream processes.
Creation of accurate plans to ensure process validation, reproducibility and adherence to regulatory standards.