BIOAdvance Consulting
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Contact
204, chemin de Chamoussière
38340 Voreppe
France
Consultant in CMC and Bioprocess
About us
As a freelance consultant, Joana supports biotech and pharmaceutical companies to bring their candidate from research and pre-clinical through clinical phases. She advices on CMC development, provides expertise on bioproduction and helps to select and supervise the right CDMO partner.
Joana has a strong expertise in chemistry, manufacturing and controls (CMC) of biologics, with over 15 years of experience in recombinant proteins/antibodies production and purification.
She was involved in 95+ projects from candidate screening, expression system optimization, process development before clinical phases I & II, process optimization before Phase III & commercialization and in GMP manufacturing.
Business offer
Activities
- Service
- CMC
- GLP compliance
- GLP compliance
- Master Cell Bank
- Production
- Cell Line development
- Clone selection
- Characterization
- Storage
- Analytical development
- Cell Culture
- Media composition
- Bioreactor conditions
- Bioproduction
- Batches production type
- Mammalian
- 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)
- USP (Scale-Up)
- Cell expansion
- Inoculation
- Low volume containers to Bioreactors
- DSP (Recovery)
- Harvest
- Filtration
- Purification
- Fill & Finish
- Aseptic filling
- Lyophilization
- 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
- Clinical trials
- Phase I
- Phase II
- Phase III
- Vaccine: antigen format platforms
- Recombinant protein expression
- Bacterial
- Cell
- CMC
- GLP compliance
- for preclinical NCS (non-clinical safety) studies
- viral safety testing
- GMP compliance
- Master Banks (cell and viral as needed)
- manufacturing
- Characterization and testing
- storage
- shipment
- Cell Culture / Fermentation
- media formulation and supply
- Bioreactor conditions (cell in suspension, adherent cell player)
- Ability to work in BSL2 conditions
- Cell expansion
- Single use technology (SUS)
- Wave-mixed bioreactors
- Stirred tank reactors
- Gene modification / Transduction
- Expression systems
- Bioproduction GMP
- Vaccine platform type
- Recombinant protein expression
- Pilot Batches scale
- Process development & optimization
- Scale-Up & Validation
- Comparability characterization protocol
- Manufacturing Volume
- Small volume (< 100 L) adjusted to phase I/II needs: specify volume
- Large volume (100 – 1000 L) adapted for phase III needs
- USP (Scale-Up)
- DSP (Recovery)
- Quality control & analytical process monitoring
- Stability Assessment
- Biosafety & Bioanalysis
- Viral safety
- Bioproduction analytical monitoring
- Key and critical process parameters (KCP, CPP)
- Identification
- Monitoring
- Batch release test
- Chemical, physical, biological testing
- Impurities detection
- Quality control test support
