ATBio-Consulting
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Contact
144 rue du Bois
59800 Lille
France
Owner & Managing Director
About us
Consultancy company specialized in CMC services for Biotech.
ATBio-Consulting is own by Antoine Thomas, PhD, a CMC expert with 20+ years of experience in small biotech and big pharma companies (TargED Biopharmaceuticals, Confo Therapeutics, ExeVir Bio, Vivet-Therapeutics, Ablynx a Sanofi company, UCB Pharma), with track records spanning NCEs, NBEs and ATMPs projects transitioning from research through pre-clinical development and clinical PoC up to commercial launch (e.g. Brivaracetam/Briviact®, Caplacizumab/Cablivi™)
Business offer
CMC Support for the selection and the lead candidate and its development from early phase to commercial phase. exemple of services;
- CDMOS/CROs selection
- phase-appropriate process, analytical and formulation development
- CMC strategy
- support for the establishment of regulatory dossiers (Module 3)
- ...
Activities
- Service
- Cardiology
- Genetic Diseases
- Oncology
- Nervous Central System
- Hematology
- Inflammation
- Other
- Immunotherapy lead generation
- Manufacturability
- Production quality
- CMC feasibility
- CMC
- GLP compliance
- GLP compliance
- Master Cell Bank
- Production
- Cell Line development
- Clone selection
- Characterization
- Storage
- Analytical development
- Cell Culture
- Media composition
- Bioreactor conditions
- Gene modification / Transduction
- Retroviral & lentiviral vectors
- Cell expansion
- Wave-mixed bioreactors
- Stirred tank reactors
- Bioproduction
- Batches production type
- Mammalian
- Insect
- Yeast
- Bacterial
- GLP compliance
- 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
- Fill & Finish
- Aseptic filling
- Lyophilization
- Batch release
- Storage matter
- Instruction
- Logistic
- Cell cryopreservation
- Controlled-rated freezer
- thaw
- Quality assurance, quality control & analytical process
- Stability Assessment
- Physical & chemical profile
- Shear/shaking
- Viscosity
- Photostability
- pH
- Freeze/thaw
- Heat/degradation
- Aggregation
- Cell line analytical development
- Host cell proteins
- Viral clearance
- Contaminants detection
- Bioproduction analytical test
- Monitoring
- Characterization
- Batch consistency
- Batch release test
- Chemical, physical, biological test
- Quality control test support
- Formulation
- Formulation
- Dose
- Stability
- Excipients
- Adjuvants
- Sterilization
- Lyophilization
- Storage stability
- Regulatory filing
- Regulatory Filing
