R & D

Synthesis

Uquifa has a well-qualified and experienced Research and Development group with 40 researchers and the ratio of PH.D.’s to BSc’s is approximately 1:1. The teams work on the discovery and development of chemical processes suitable for the efficient manufacture of APIs and key intermediates.

In this laboratory our Synthesis Chemists are capable of manufacture products from 1g to 1kg and they make processes scalable, safe and environmentally friendly.   The researchers have access to state of the art equipment including RC-1, LC-MS, GC-MS and are experienced in DOE.

 

All available chemical literature and patents are considered together with in-house know-how to give the best practical means for the synthesis of your product. Following investigative laboratory work a sample is produced.

The new R&D Laboratory is placed in Sant Celoni and it is online since 2005. The 800 square meters laboratory hold the Synthesis and Analytical development laboratories, with 20 fume hoods (3 walk in), a kilolab and a library. The synthesis laboratory equipment includes several hydrogenators of different sizes, a freeze drier, liquid-liquid extraction columns and a molecular distiller.

 

Analytical Development

The Research and Development group includes a dedicated analytical development team with highly qualified personnel.

The duties of this analytical team are:
  • Development and validation of new analytical methods working in parallel with synthetic development team.
  • Analytical support on pilot plant processes. 
  • Stability testing on finished products and related intermediates.

 

The resources to carry out these analytical duties are:

  • 8 member team including 4BSc, 1 validation analyst and 3 analysts working on 24 hours shift.
  • Chromatographic systems: HPLC (UV and/or PDA detection), GC  (FID and headspace)
  • Characterization techniques: FT-IR, UV, DSC for polymorphism studies.   
  • Karl Fisher (coulometer and potentiometer), apparent density analyser, particle size distribution (Air Jet and Laser diffraction) and optical rotation.

 

 Scaling up

Uquifa has pilot plants both in our Mexican and Sant Celoni's facilities.

These facilities are located on FDA approved sites and the pilot plants in particular have been inspected and approved by the FDA for small scale API production. Dedicated qualified technicians run the plants under cGMP and using identical quality control systems to those used for commercial production.

 

The two Pilot Plants produce kilograms to multi-kilograms quantities for preclinical and clinical trials and for small scale commercial production. Installations are designed to be flexible allowing many combinations of reactors, filters and dryers to be used in order to perform the same type of reactions that are conducted at industrial scale, such as nitrations, ozonolysis, hydrogenations, reactions using other gaseous reagents such as isobutylene and chlorine and those requiring cryogenic capability.

The modern UQUIFA pilot plant and small scale production unit, built in 2002 at the Sant Celoni site in Spain optimizes laboratory process to produce material for clinical trials as well as for commercial scale.
Since 2002, our technicians have scaled-up more that 25 custom synthesis project and more that 30 API's.