Alter Ego biotech
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Contact
762 rue du docteur maurer
78630 Orgeval
France
CEO
About us
Alter Ego Biotech is an independent CMC consultancy founded in 2022, operating internationally. We support cell therapy developers on the industrialization of their process, from early development to GMP manufacturing and regulatory submission.
We provide strategic and operational CMC consulting to sponsors whose manufacturing or regulatory path is still to be built: autologous and allogeneic cell therapies, gene-modified cells, and the biological starting and ancillary materials they depend on. We work as CMC lead, project manager or operational expert, embedded within client teams.
Alter Ego Biotech is an approved Bpifrance expert (Cercle des Experts) and holds the French CIR research tax credit accreditation.
Business offer
CMC strategy and regulatory preparation. CMC development roadmap for cell therapy products, phase-appropriate CMC requirements, preparation of the CMC sections of IND and IMPD filings, and support for interactions with regulatory authorities.
Quality by Design and control strategy. Target product profile and QTPP, identification and criticality assessment of critical quality attributes and critical process parameters, process control strategy, analytical control strategy, release specifications, QbD methodology and team training.
CDMO selection and assessment. Technical evaluation of cell therapy manufacturing partners, due diligence, audit support, and definition of what remains the sponsor's responsibility once manufacturing is outsourced.
Technology transfer and comparability. Transfer strategy and documentation packages, transfer risk assessment, design and interpretation of transfer studies, and comparability between sites, scales or process versions for products already in clinical development.
Scale-up and process industrialization. Process characterization, scale-up strategy, process robustness, the move from an academic or pilot process to a GMP process, and the shift from an open and manual process to a closed and controlled one.
Contamination control strategy. Design and challenge of the contamination control strategy, sterility assurance, cross-contamination control, cleaning and decontamination strategy, validation of single-use systems.
Process validation. Validation master planning, process performance qualification, continued process verification, and validation of ancillary processes.
Cell bank qualification. Strategy and qualification of Master, Working and Seed Banks.
Engagement models. CMC lead embedded in the client team, execution of technical work packages including project management, or ad hoc expertise for due diligence, technology assessment, troubleshooting and audit. Fixed price or time-based contracts.
Activities
- Consulting
- Cell origin
- Single donor
- Pool of donors
- Cell Banking
- IPs
- MSC
- CD34 + HSC cells
- Off the shelf
- Apheresis
- Target cell isolation
- iPS reprogramming
- Differentiated Cell
- Production Cell
- Safety donor-derived therapies
- Cell modification
- Direct reprogramming
- Cell Activation
- CMC/analytical quality assessment, quality control
- Cleaning
- Cross contamination
- Sterility
- Contaminants detection
- Safety for gene-edited cells
- translocation
- anti-nuclease response
- cytokine-independent growth
- Bioproduction engineering
- Cell Expansion
- Stirred tank Bioreactor
- Wave bioreactor
- Cell factory
- Microcarrier-based culture
- Organoids culture
- Capsules culture
- Scale-Up
- Process optimization
- Automated manufacturing
- On-line monitoring
- Automated high throughput microbioreactor system
- Non-GMP expansion
- GMP expansion
- Other
- Purification/Extraction
- Filtration / microfiltration / ultrafiltration
- Centrifugation
- Chromatography
- CGMP
- Formulation
- Conditioning
- Storage
- Gene Delivery System
- Lentivirus
- Other Retrovirus
- Adeno-Associated Virus (AAV)
- Adenovirus (ADV)
- Gene Gun
- Electroporation
- Lipid chemical methods
- Protein chemical methods
- Mixed chemical methods
- Inorganic methods
- Bioproduction/CMC/Analytical Quality Assessment, Quality Control
- Bioproduction
- Scale-Up
- Automated manufacturing
- Non-GMP pilot batch
- GMP batch
- Cleaning
- CGMP
- Sterility
- Contaminants detection
- Safety for gene-edited cells
- Translocation
- anti-nuclease response
- cytokine-independent growth
