Merck Biodevelopment S.A.S
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Contact
1 rue Jacques Monod
33650 Martillac
France
Directrice de site / Présidente de l'entité légale Merck Biodevelopment S.A.S
About us
Merck Biodevelopment was founded in 1987 and has been GMP-certified since 1995.
With more than 35 years of experience, the site has grown to more than 470 employees and covers 72,000m2 in the Montesquieu Technopôle campus, near Bordeaux.
At the crossroads of research and industrial production, the site's main mission is to ensure the production of active pharmaceutical substances and mammalian biologics in compliance with GMP standards.
Business offer
We provide services for biotech and start-up companies who need to develop and commercialize biologics.
Our Martillac Mammalian Biologics Center of Excellence site is dedicated to early and late-phase projects activities, including
- cell line development,
- - cell banking
- - analytical methods development and validation
- - process development and optimization
- - formulation
- - pilot production (50L to 2,000L)
- - scale-up
- - GMP clinical and commercial drug substance manufacturing (200L and 2,000L)
- - process validation
- - regulatory support.
- Our tech transfer program allows biotech companies to transfer their process to our facilities at every stage – from pre-clinical to commercial supply.
Activities
- Service
- Genetic Diseases
- Oncology
- Nervous Central System
- Infectiology
- Immunology
- Inflammation
- Other
- CMC
- GLP compliance
- Master Cell Bank
- Production
- Cell Line development
- Clone selection
- Characterization
- Storage
- Analytical development
- Cell Culture
- Media composition
- Bioreactor conditions
- Cell expansion
- Stirred tank reactors
- Bioproduction
- Batches production type
- Mammalian
- GMP compliance
- Pilot Batches
- Tests
- Optimization
- Scale-Up process
- Process optimization & validation
- Volume
- Preclinical / Tox
- Low volume (< 200 L)
- High volume (200 – 2000 L)
- Very high volume (> 2000 L)
- Commercial
- USP (Scale-Up)
- Cell expansion
- Inoculation
- Low volume containers to Bioreactors
- DSP (Recovery)
- Harvest
- Filtration
- Purification
- Quality assurance, quality control & analytical process
- Stability Assessment
- Physical & chemical profile
- Shear/shaking
- Viscosity
- pH
- Freeze/thaw
- Heat/degradation
- Aggregation
- Cell line analytical development
- Host cell proteins
- Viral clearance
- Contaminants detection
- Biosafety & Bioanalysis
- Toxicology
- PK/PD features
- Impurities detection
- Bioproduction analytical test
- Monitoring
- Characterization
- Batch consistency
