CDMO Business Our Offering

Global R&D

Global R&D Team formed of over 170 passionate and talented people, 30% of them with a PhD degree in Chemistry, and with track record in the development of API projects

At Esteve CDMO, we have R&D permises strategically located in three continents (Spain, Mexico & China) with centralized R&D management in Spain.

Industry-oriented Process Development in all the projects, leaded by highly skilled people

Flexible gram-to-multikilo Process Development and Scale up (from 2 to 30L glass-reactor to 50 to 600L pilot Plant reactor)

Development activities using QbD Approach: DoE, Risk Assessment, PAR, PAT, reaction kinetics, process simulation, scale down, …

Simultaneous chemical process and analytical development, scale-up, and analytical methods transfer and validation.

Development of robust and sustainable processes.

Capability to support industrialization of new products in three continents within project core teams. Get to know our project management

R&D Capabilities

Expertise in complex chemical reactions and new technologies, with special attention to the solid form of the final API (particle size, polymorphism...), process safety studies, process engineering, impurity tracking, structural elucidation… 

Specialized softwares (Scifinder, Dynochem, VisiMix, Mirabilis,..) at the service of the projects

Integrated R&D, Analytical and Process Development of HPAPI (down to 30 ng/m³), Spray Drying.

Assistance to our customers to select and justify the regulatory starting materials, design the impurity control strategy of the whole process and perform the PMIs assessment of the process including the nitrosamines assessment. 

Technologies

Esteve CDMO operates in a broad range of state-of-the-art technologies. In addition to Hydrogenation, high and low temperature reactions, we have capabilities in: HPAPI, SDD, chromatography...  

Contemporary manufacturing approaches such as the use of flow chemistry, biocatalysts, process, and solid engineering are also being developed.

Diverse techniques like XRF, benchtop NMR and PAR probes (NIR, Raman, Particle Size, Turbidity...) are being refined for integration into the processes.  Get to know our technologies 

We maintain our edge through extensive collaboration with prestigious universities and specialized contract research organizations (CROs)