ERASMUS Biomanufacturing, Consulting & Expertise
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Contact
1 Rue du Marsan
78660 Prunay en Yvelines
France
CSO - COO
About us
Expertise in bioproduction. fee for service company of 2 experts.
CMC aspects for the production of biologics, premium cosmetics ingredients.
Focus on biologics (mAbs, fragments, cytokines, fusion proteins)
Conventional expression systems (CHO, E.coli) as well as non conventionnal (Plants, Pichia, Fungy).
Flexible & hands-on experts. Accuracy and deadline compliant.
Extensive track record, in Europe, Asia, Middle East, South America (Ask for details).
Business offer
25+ years supporting the biotech & biopharma arena
12 years consulting services in CMC – Bioproduction
Technical, Manufacturing & Quality expertise (IND dossier) Strategic guidance for refinancing & due diligences (In/Out licencing).
Hands-on management of Tech transfer & CDMOs/CROs Track record from R&D through to Phase II
Patent portfolio analysis
Tecnical audit of production suite or plants.
Activities
- Service
- Oncology
- Nervous Central System
- Immunology
- Target selection & validation
- Expression and pathway analysis of target
- quantification of target
- Research exploratory companion biomarkers
- Hit discovery
- Bioinformatics prediction & analysis
- Immunotherapy lead generation
- Binding & Affinity
- Potency & Specificity
- Functional effects
- ADCC, ADCP & CDC
- Antigen density target
- Internalization
- Pharmacology & Biological activity
- PK/PD bioavailability
- Mode of Action
- Therapeutic efficacy
- Safety
- Immunogenicity
- Specificity
- Manufacturability
- Production quality
- CMC feasibility
- Gene modification / Transduction
- Retroviral & lentiviral vectors
- Transposon/transposase
- mRNA electroporation
- CRISPR/Cas9
- Immunotherapy lead optimization
- Engineering
- ADC
- Linkers
- Payloads
- Protein scaffolds
- Fragments
- Multi-, bispecific
- Fc-fusion proteins
- Antibody humanization
- Affinity maturation
- Preclinical biomarkers
- Mechanism/Function
- Drug-Target interaction
- Specificity
- Research exploratory Companion biomarkers
- Animal biomarkers
- Human biomarkers
- 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
- Biosafety & Bioanalysis
- Toxicology
- PK/PD features
- Impurities detection
- Bioproduction analytical test
- Monitoring
- Characterization
- Batch consistency
- Batch release test
- Chemical, physical, biological test
- Quality control test support
- Post-production test
- Real-time stability test
- Formulation
- Formulation
- Dose
- Stability
- Excipients
- Adjuvants
- Sterilization
- Lyophilization
- Storage stability
- Delivery
- Route of Administration
- Devices associated
- Clinical trials
- Phase I
- Phase II
- Clinical biomarkers
- Predictive biomarkers
- Treatment efficacy
- Risk/benefit profile
- Surrogate markers
- Disease progression monitoring
- Regulatory filing
- Regulatory Filing
- Companion biomarkers
- Toxicity
