Our Global R&D Department is responsible for the industry-oriented Process Development of all new products, and has capability to support the industrialization of these products in the three continents.
R&D combines experienced people with more than 20 years working on process development together with a great capacity of innovation, introducing new concepts to the development activities like synthetic and analytical QbD, simulation and PAT among others.
R&D Spain is located in the former Production Plant of Esteve Química in Barcelona. Currently, this site is dedicated only to R&D activities. The facilities contain state of the art Laboratories, Kilolabs and a Pilot Plant as well.
R&D China is located in the EHP Production Plant in Shaoxing and gets state of the art Laboratories and Kilolab.
In Sintenovo (Mexico Plant), there is a small R&D lab able to give support to the products being transferred or already manufactured to the Plant.
The Global R&D Team is formed by over 100 passionate and talented people, 30% of them with a PhD degree in Chemistry, and with track record in the development of API projects.
The R&D Centers of Spain and China, for the incoming projects, perform simultaneous chemical process and analytical development, scale-up, and analytical methods transfer and validation.
R&D premises in 3 continents, with centralized R&D management and dedicated R&D facility in Spain
• Support is provided in different sites strategically located. R&D teams in Spain (Main R&D Center), China and Mexico.
• Centralized R&D management in Spain.
• R&D teams have structure to support transfers and scale-up at all the sites.
Core teams are set up for all incoming projects, from evaluation to validation, and R&D people, together with Business Development, Regulatory, Purchasing, Production are involved during the entire development process.
Supporting the Development activities and trying to be moving on the crest of the wave in terms of innovation and the methodologies applied to the process development, concepts such as QbD, PAR, DoE, reaction kinetics, process simulation, scale down, are leaded by highly skilled people. Special attention is also paid to the solid form of the final API (particle size, polymorphism...) together with a great capacity on impurity tracking and structural elucidation.
The R&D teams also supports product validation and industrialization by preparing QRAs, HAZOPs, etc.
Troubleshooting, continuous process improvement, wastes reduction and valorization, are activities also carried out by the R&D team.
On the other hand, R&D has a large number of external collaborations with Universities and specialized CRO in order to be up to date on the chemistry and to cover aspects and technologies beyond our own limitations.
R&D capabilities and services
The main R&D Center, located in Barcelona, contains several Synthesis and Analysis Labs, but also a Kilolab (up to 30 L glass reactors) and two Pilot Plants (up to 600 L reactors; total reaction volume: 3 m3). On the other hand, it is worth mentioning the hydrogenation laboratory (up to 5L, 50 bars), where high pressure reactions are developed and optimized, and the High Potent API lab, where development of this kind of compounds is done (up to 1 microg/m³).
The R&D Center in China, contains also a hydrogenation lab (up to 2L; 10 bar) and a Klab (up to 30L).
New technologies are also developed in our labs in order to improve the control of the processes and to reduce the analysis time in the QC labs. Techniques such as XRF, benchtop NMR and PAR probes (NIR, Raman, FBRM, Microscopy, Particle Size, Turbidity...) are being developed to be used in the processes. New manufacturing approaches such as flow chemistry, biocatalysis and process and solid engineering are also developed. Other capabilities are: process safety studies and impurity tracking and structural elucidation (HPLC_2D- QTof).
Analytical methods development by QbD approach using specialized software can be done, giving a great knowledge of the methods and flexibility in terms of easy change implementation and adaptation along the process evolution.
We can help 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. These activities ensure our clients that the safety of the process is guaranteed and patients will be protected.
Chemistries, special reaction, technologies and equipment
|Short list/table of special reactions (1)||In house Technologies/Services||In house lab equipment|
|Cross-coupling reactions||Cryogenic reactions||NMR (400 MHz)|
|Organometallics||High pressure reactions||NMR (benchtop, 60 MHz)|
|Chemical reductions and oxidations||Peptide chemistry||HPLC/UPLC/GC|
|Hydrogenation||Flow chemistry||2D HPLC|
|Enzymatic reactions||Process safety||MS detectors (QDA, QTOF)|
|Chiral chemistry||DoE (process and analytical)||XRPD|
|PAT (NMR, NIR, Raman, PSD)||SEM|
|Particle size and polimorphism studies||Multireactors / automatic reactors|
|Micronization / milling||Reaction calorimeter|
|Spray Drying||Lab Spray Drying|
|Chromathography||Lab Flow chemistry|
|Impurities assessment / tracking / characterization||Lab micronization and milling|
|High pressure reactors (glass, hastelloy)|
1. This is a general list. We can perform many other king of chemical reactions.
2. We have access to other technologies/equipment through collaborations with Universities, Research Centers and CROs.