CMC Solutions
CMC Development Oversight
Quality Target Product Profile development based on Target Product Profile
Drug substance
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Small/large molecules
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ASOs/SiRNA
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ATMPs
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Peptides
Drug product
- Oral delivery
- Parenteral delivery (SC, IV, intrathecal,..)
- (Trans)dermal delivery
- Nasal delivery
Clinical supply management
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Packaging & labeling
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Blinding/randomization
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Comparator sourcing/ shipment/storage
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Compatibility studies
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Pharmacy manual preparation
Regulatory CMC
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CMC development strategy
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Briefing book
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Response to questions
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IMPD/IND/MAA/NDA
GMP Quality oversight
Management of all CMC-related activities from preclinical phase to late phase development including but not limited to:
Vendor selection / management
Analytical development / validation
Impurity management
Formulation development / process development
Stability studies
Set-up and shelf-life management
Scientific & Regulatory writing
PPQ prep / mgt / quality & scientific risk management
Emilyne Blattes
R&D Leader, Scientific Development & CMC
A rigorous and methodical biochemist with solid analytical and CMC skills and over ten years of experience in scientific research. Highly interested in regulatory strategy, has a global view on pharmaceutical project development.
My work/involvement in a project often starts by performing a project gap assessment, which often reveals the tip of the iceberg called “challenges” and helps to reflect on the major project hurdles. It also obliges you to have a global view of combining the bricks of the puzzle into one single big piece. CMC is regarded as the least important point by most of our academic clients. But it involves the tested product that will provide the right pharmacodynamic effect in a human being. It’s what you aim for! You need the right amount of formulated products that fulfill regulatory requirements of the required quality and characterization level from the right API of satisfying purity. Only with this single sentence, I can already involve 4-5 of my colleagues having expertise in quality, analytics, formulation, regulatory, and activities oversight.
”CMC is often underestimated when it has a major project impact, I like to remind colleagues/clients of that!