The Exclusive Partnership Model
- Dedicated Project Management: A single point of contact for constant monitoring of all project activities and timelines.
- Western Supply Chain: A production chain entirely based in Europe to ensure maximum resilience and business continuity.
- Quality Assurance (QA): A team dedicated to risk mitigation and proactive management of Change Control and Issue Management.
How our Exclusive Partnership Model works
Process and Analytical Development (R&D)
Our in-house R&D team works closely with partners to design exclusive Routes of Synthesis (RoS) and optimized processes.
- Tailor-made Design: Development of manufacturing processes and analytical methods in full compliance with ICH Q14 guidelines.
- Solid State Expertise: Polymorphism studies, morphology evaluation, and Particle Size Distribution (PSD) design to ensure the desired performance of the drug substance.
- Troubleshooting: Dedicated support for resolving criticalities in existing processes.
Scaling & Validation
We guide your product through the critical phases of scale-up, minimizing risks and accelerating time-to-market.
- Parameter Definition: Identification of Critical Process Parameters (CPP) and process characterization studies (PAR and F&P).
- Rigorous Validation: Production of validation batches, cleaning protocols, and equipment validation in cGMP environments.
- Regulatory Support: Comprehensive assistance in preparing documentation for global authorities (FDA, EMA, AIFA).
Large-Scale Commercial Manufacturing
With a production capacity ranging from laboratory scale to multi-hundred kilograms, we offer the flexibility needed for every market demand.
- Broad Manufacturing Range: Reactors from 175 L up to 12,000 L in advanced materials (Hastelloy-C 22, SS316, Glass-lined).
- HPAPI Specialization: Expert handling of Highly Potent Active Pharmaceutical Ingredients (up to OEB 5) and cytotoxic compounds under total containment.
- Differentiating Technologies: In-house micronization (5 cGMP suites) and sterilization via aseptic filtration in compliance with Annex 1.
Differentiating Technologies & Complex Chemistry
We excel in managing challenging chemical transformations, providing our partners with access to a wide array of specialized capabilities:
Advanced Reactions
Expertise in enzymatic reactions, Grignard and Organo-Lithium usage, and complex oxidations (Peroxides)
Hydrogenation at Scale
Dedicated 3,000L reactor for large-scale hydrogenation processes
Hazardous Reagents Handling
Safe and efficient management of halogenation (HF, Br2, I2) and reactions involving POCl3, SOCl2, and ZnCl2
Specialized Expertise
Proven track record in Organometallic chemistry and Wolff-Kishner reactions
Largest OEB5 containment in Europe
Following a €35M expansion of the Farmabios site, we operate one of the largest OEB5 containment platforms in Europe. Purpose-built facilities enable safe, large-scale manufacturing of highly potent compounds under total containment, supporting both clinical and commercial supply.
• Dedicated OEB5 production suites with advanced engineering controls.
• Designed for high-volume HPAPI and steroidal API manufacturing.
• Scalable capacity aligned with global regulatory standards.
Why Choose Farmabios as your CDMO?
With an average of 10+ R&D projects launched every year and a solid reputation built over 60 years, Farmabios is not just a manufacturer: we are the technical extension of your company.