Alter Ego Biotech
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Contact
France
Co-founder
About us
Alter Ego Biotech is an independent CMC consultancy founded in 2022, operating internationally. We support developers of cell and gene therapies, CAR-T and vaccines on the industrialization of their process, from preparation for first-in-human through GMP manufacturing and regulatory submission.
We provide strategic and operational CMC consulting to sponsors developing products whose manufacturing or regulatory path is still to be built: viral vectors including lentiviral vectors and AAV, nonviral delivery, gene-modified cell therapies, mRNA and plasmid DNA, prophylactic and therapeutic vaccines, and the biological starting and ancillary materials they depend on. We work as CMC lead, project manager or operational expert, embedded within client teams.
Our co-founder Margaux Desnoyer has been an independent expert for Bpifrance since 2022, a member of "Le cercle des experts Bpifrance", assessing projects under the France 2030 plan. We hold the French CIR research tax credit accreditation.
Business offer
CMC strategy and regulatory preparation. CMC development roadmap for cell and gene therapy, mRNA and vaccine 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 and QbD methodology. Applied to starting materials such as vectors and plasmids and to the drug product, with the link between the two made explicit.
CDMO selection and assessment. Technical evaluation of vector, cell therapy and vaccine manufacturing partners, due diligence, technical site visits, and definition of what remains the sponsor's responsibility once manufacturing is outsourced. This includes split-site setups where a starting material and the drug product are manufactured in different places.
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 between batches and between patients, cleaning and decontamination strategy, single-use strategy.
Process validation. Validation master planning, process performance qualification and continued process verification.
Cell bank, viral seed and starting material qualification. Strategy and qualification of Master, Working and Seed Banks including viral seeds, qualification of viral vectors and plasmid DNA used as starting materials, and qualification of ancillary materials.
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 CMC readiness reviews. Fixed price or time-based contracts.
Activities
- Consulting
- Cardiology
- Genetic Diseases
- Oncology
- Nervous Central System
- Hematology
- Infectiology
- Immunology
- Ophthalmology
- Inflammation
- Cell origin
- Cell Banking
- CMC/analytical quality assessment, quality control
- Cleaning
- Cross contamination
- Sterility
- Bioproduction engineering
- Cell Expansion
- Scale-Up
- Process optimization
- CGMP
- Gene Delivery System
- Lentivirus
- Adeno-Associated Virus (AAV)
- Adenovirus (ADV)
- Electroporation
- Bioproduction/CMC/Analytical Quality Assessment, Quality Control
- Bioproduction
- Scale-Up
- Non-GMP pilot batch
- GMP batch
- Cleaning
- CGMP
- Sterility
- Deviations
- CMC
- GMP compliance
- Master Banks (cell and viral as needed)
- Vaccine delivery/Administration routes
- Route of Administration
- Intramuscular route
- intradermal route
- Nasal route
- Mucosal routes
- Other devices: specify
- Delivery/ Encapsulation
- Polymeric Nanoparticles
- Lipid Nanoparticles
- Nano emulsions
- Adjuvanted delivery systems
- Clinical trials
- Phase I
- Phase II (human challenge trials)
- Phase III (large population pending pathogen prevalence)
- Bioproduction GMP
- Vaccine platform type
- Recombinant protein expression
- Virus-like particles (VLP) and nanoparticle-based carriers
- killed/inactivated virus
- Live attenuated virus
- Viral vector encoding target antigen
- DNA plasmid vaccine
- mRNA vaccine
- Lipid delivery vehicle
- Pilot Batches scale
- Process development & optimization
- Scale-Up & Validation
- Comparability characterization protocol
- 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
- Potency assay
- Quality control test support
- Regulatory Filing
- Regulatory Filing
- New Drug Application (IND)
- Investigational Medicinal Product (IMPT) for clinical investigations (EMA)
- Common Technical document (CTD) section 3 (CMC) 4 (NCS) and 5 (Clinics) for submission
