ULTRace Development Partner
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Contact
30 Avenue Jean Jaurès
91400 ORSAY
France
President
About us
ULTRace DP is a "partner" company that assists biotech and start-up companies by providing strategic and operational support where necessary at each and every stage of development, in order to bring their innovative idea/concept or project successfully from the inception phase through to exit or market launch.
By combining scientific, pharmaceutical and medical skills, a long track record and extensive development experience (translational research, pre-clinical, CMC/biomanufacturing and industrialization, clinical, regulatory and business) on all types of technology (chemical, biological, innovative therapy, etc.) as well as a commercial vision, ULTRace DP can "integrate" your team (CDO, COO, Head CMC, CMO), steer your project and help bring development and fund-raising to fruition throughout its duration, until its best possible outcome.
We give preference to long-term missions that enable mutual commitment and value creation for the company, which is what the word "PARTNER" in our name covers.
Business offer
This takes the form of a definition of, or decisive contribution to, the overall strategy, the design of the TPP and development plan, and its strategic planning (all phases).
This is complemented by a number of services (single or multiple) that we develop according to the needs expressed:
- Team building and management
- Operational management of all R&D stages of the project (from hits/lead selection to MA submission)
- Preparation of scientific advice and files for regulatory submission to authorities (EMA, FDA...)
- Due diligence
- Value creation and contribution to fund-raising and company pitches
Activities
- Service
- Target selection & validation
- Expression and pathway analysis of target
- Assay development in in-vitro & in-vivo models
- Hit discovery
- Screening & Identification
- Indication searching
- 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
- Hypersensitivity & allergies
- Immunotoxicology
- Specificity
- Manufacturability
- Production quality
- CMC feasibility
- Cell activation
- Immunotherapy lead optimization
- Engineering
- ADC
- Linkers
- Fragments
- Multi-, bispecific
- Fc-fusion proteins
- Indication Prioritization
- Antibody humanization
- Affinity maturation
- Proof of concept
- Pharmacology potency
- Exploratory toxicology
- in-vitro & ex-vivo models
- in-vivo models
- Preclinical biomarkers
- Mechanism/Function
- Predictive biomarkers
- CMC
- GLP compliance
- GLP compliance
- Master Cell Bank
- Cell Culture
- Gene modification / Transduction
- Cell expansion
- 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
- Biosafety & Bioanalysis
- Bioproduction analytical test
- Batch release test
- Post-production test
- Formulation
- Formulation
- Delivery
- Clinical trials
- Phase I
- Phase II
- Phase III
- Phase IV
- Clinical biomarkers
- Predictive biomarkers
- Treatment efficacy
- Population stratification
- Risk/benefit profile
- Disease progression / follow-up
- Safety
- PK/PD features
- Surrogate markers
- Disease progression monitoring
- Regulatory filing
- Regulatory Filing
- Companion biomarkers
- Treatment efficacy
- Cell origin
- Pool of donors
- Cell Banking
- CMC/analytical quality assessment, quality control
- Cleaning
- Cross contamination
- Sterility
- Deviations
- Contaminants detection
- Safety for gene-edited cells
- Bioproduction engineering
- Cell Expansion
- Purification/Extraction
- CGMP
- Formulation
- Conditioning
- Target Identification
- Assay development in in-vitro & in-vivo models
- Bioproduction/CMC/Analytical Quality Assessment, Quality Control
- Bioproduction
- Scale-Up
- Tracking process
- Monitoring logistics
- Non-GMP pilot batch
- GMP batch
- Cleaning
- CGMP
- Cross contamination
- Sterility
- Deviations
- Quality control
- Contaminants detection
- CMC
- GLP compliance
- GMP compliance
- Master Banks (cell and viral as needed)
- Cell Culture / Fermentation
- Cell expansion
- Formulation
- Formulation
- Vaccine delivery/Administration routes
- Route of Administration
- Intramuscular route
- Nasal route
- Regulatory safety
- Regulatory safety tests
- Viral safety
- Immunotoxicology
- Clinical trials
- Phase I
- Phase II (human challenge trials)
- Phase III (large population pending pathogen prevalence)
- Immune monitoring
- Bioproduction GMP
- Vaccine platform type
- Pilot Batches scale
- Manufacturing Volume
- USP (Scale-Up)
- DSP (Recovery)
- Fill & finish
- Prefilled syringe
- Quality control & analytical process monitoring
- Stability Assessment
- Biosafety & Bioanalysis
- Bioproduction analytical monitoring
- Batch release test
- 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
