Unither Pharmaceuticals
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Contact
5 rue Saint Georges
75009 Paris
France
BUSINESS DEVELOPMENT MANAGER • COMMERCIAL
About us
Unither Pharmaceuticals is a pharmaceutical subcontractor specializing in the development and manufacturing of single-dose and multidose liquid formulations (including eye drops, saline solutions, asthma medications in BFS single doses, and liquid stick-packs) for originator pharmaceutical companies and generic manufacturers. Currently employing more than 2,200 people in eight manufacturing plants in France, the United States, Brazil and China, Unither Pharmaceuticals has sales of €475 million in 2023.
Business offer
The CDMO, a specialist in liquid health solutions, offers a comprehensive model encompassing contract development and manufacturing from pre-clinical to commercial stages, collaborative co-development with clients, and the licensing of turnkey products and dossiers.
Recent advancements have introduced the possibility of utilizing BFS (Blow-Fill-Seal) technology, in which Unither Pharmaceuticals is the world leader, to design aseptic packaging systems combining the efficiency of high-throughput production with the highest guarantees of sterility. It has led to the creation of Euroject® solution, an innovative BFS-based device for single dose injection of therapeutics
For further information about the Unither Pharmaceuticals group, please visit www.unither-pharma.com.
Activities
- Therapeutic Product
- Service
- Pre-industrial demonstrator
- Cardiology
- Genetic Diseases
- Oncology
- Nervous Central System
- Hematology
- Infectiology
- Immunology
- Ophthalmology
- Inflammation
- Other
- Bioproduction
- 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
- Fill & Finish
- Aseptic filling
- 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
- 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
- Storage stability
- Delivery
- Route of Administration
- Devices associated
- Regulatory filing
- Regulatory Filing
- Bioproduction engineering
- Formulation
- Conditioning
- Storage
- Bioproduction/CMC/Analytical Quality Assessment, Quality Control
- GMP batch
- Bioproduction GMP
- Vaccine platform type
- Recombinant protein expression
- Synthetic Peptides or oligomers
- 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
- Outer-membrane vesicles (OMV)
- Polysaccharides/ conjugated vaccines
- Other
- 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
- Final scale up volume (> 1000 L) and validation for manufacturing
- Commercial supply during life cycle management
- Fill & finish
- Prefilled syringe
- Quality control & analytical process monitoring
- Batch release test
- Chemical, physical, biological testing
- 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
