ESTEVE CDMO is a global pure-play CDMO partner supporting pharmaceutical and biotech innovators in the development and manufacture of complex small-molecule APIs, highly potent APIs (HPAPIs) and advanced pharmaceutical intermediates – from early development through commercial supply.
ESTEVE CDMO brings more than 60 years of experience serving highly regulated markets. By connecting development, analytical, manufacturing, quality and regulatory expertise, we help customers address any challenges – from scale-up and regulatory readiness to project visibility and continuity into manufacturing.
Facilities and Global R&D
Strategically distributed across three continents, ESTEVE CDMO’s six full cGMP, state-of-the-art, multipurpose manufacturing sites located in Spain, Mexico, the US and China provide more than 1,000 m³ of reaction volume capacity, combining global reach with the ability to support programmes across all stages of the product lifecycle.
ESTEVE CDMO’s Global R&D network works across process development, analytical development, process engineering and scale-up. Development is approached with industrialisation in mind from the beginning, helping customers anticipate next steps and support smooth progression towards plant scale.
Industry-oriented process development supports customers in building robust, scalable processes while maintaining visibility on what comes next:
- Flexible gram-to-multikilo process development and scale-up
- Development using QbD/DoE and PAR studies, supported by PAT tools, process simulation, kinetics and scale-down
- Integrated process and analytical development, analytical method validation and technology transfer
- Development of robust and sustainable processes
- Technology transfer and industrialisation across our global manufacturing network, supported by cross-functional project teams
Specialised capabilities include:
- Spray drying and particle engineering, from development through commercial production
- HPAPI development and manufacturing
- Flow chemistry
These technologies broaden the development and manufacturing options available for complex molecules, supported by teams experienced in translating development requirements into scalable manufacturing processes.
Manufacturing: APIs, HPAPIs & Pharmaceutical Intermediates
Manufacturing capabilities range from early clinical-scale quantities to metric tons of commercial production. ESTEVE CDMO’s facilities are designed to support a smooth and efficient transition from development through scale-up and manufacturing.
ESTEVE CDMO works with a wide range of chemical reactions and products, while the final stages of synthesis and API handling are performed in a pharmaceutical environment. ISO 8 cleanrooms provide controlled conditions for these critical operations, supporting consistent product quality and compliance with stringent regulatory standards.
Manufacturing reactors across the network range from approximately 100 L to 12,000 L, complemented by smaller-scale development and kilo-lab equipment, providing flexibility in batch size and quantity requirements throughout the product lifecycle.
Continuity also extends to the way projects are managed. The same core project team remains involved throughout the product lifecycle, preserving process knowledge, maintaining alignment and enabling smoother transitions from development to commercial supply.
This connected approach reflects The Science of Collaboration – bringing the right expertise together around each customer’s project to help advance complex molecules with greater visibility, continuity and confidence.
Meet ESTEVE CDMO at Stand #6K42 at CPHI Milan.
Want to book a meeting with the ESTEVE CDMO team? Get in touch to schedule a meeting.
