Multifunctional project management teams are available to professionally
understand clients needs and to translate them into high quality products
manufacturing. Open, team-based, matrix communication tools are in place to
allow a constant flow of information toward clients, within strict
confidentiality rules.
In the pharma area, production lines
for cGMP manufacturing of small molecules as well as pharmaceutical proteins
are available. The facilities comply with all relevant regulations and are
inspected on a regular basis by various authorities.
Microbial capabilities:
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Production strain construction and/or improvement
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Production process development & optimization
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Analytical development
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Chemical modification of fermentation products
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Enzymatic modification of chemicals & fermentation products
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In-process and final product analytics
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non-cGMP manufacturing from 10 L to 100 m3
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cGMP manufacturing from 3 m3 to 35 m3
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FDA / EMEA-approved facilities with up to Class 10,000 clean rooms
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Purification chromatography
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-20º C cGMP storage for APIs
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Stability studies
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Regulatory affairs support (IND / IMPD and NDA / BLA filing)
