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R & D

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DEPARTMENT OF RESEARCH AND DEVELOPMENT

Contract research by EUROFINS BEL/NOVAMANN s.r.o.  researchers

RESEARCH AND DEVELOPMENT Laboratories can offer you:

  • Polymorphism research
  • New synthesis  of old compounds
  • Synthesis of novel compounds
  • Reference standards for intermediates
  • Synthesis of API analogs
  • Chemical process development
  • Optimization or redesign of entire process or individual steps 
    Isolation and identification of impurities

R&D dept. offers a contract research to pharmaceutical companies.  The aim of the Research & Development department is to create new products according to a schedule of conditions defined between our customers and our team as well as to improve existing materials for optimized products.

Experience

Our staff has cumulative experience in the synthesis of complex organic molecules.  Our expertise includes, but is not limited to:

  • Organic synthesis and medicinal chemistry
  • Chiral building blocks
  • Isolation and identification of impurities
  • Optical resolution/Racemization
  • Complex heterocycles
  • Preliminary polymorphism screening and Comprehensive polymorphism study.
  • Salt screening and characterization of crystalline salts.

Product Specifications and Characterization

We can assist you in developing specifications or synthesizing products according to yours.  Product characterization include: LC/ MS, GC, GC/MS, HPLC, FT-IR, UV/VIS polarimetry, elemental analysis.  1H , 13C  NMR, DSC/TGA, XRPD  (in collaboration).

DEPARTMENT OF RESEARCH AND DEVELOPMENT

New compounds, novel analogues, new patentable intellectual property 

RESEARCH AND DEVELOPMENT dept. is a contract research team of Bel /Novamann specializing in custom synthesis/polymorphism research of organic compounds and fine organic chemicals.

Flexible laboratory organization structure allowing resources to be focused on project needs (an ad hoc team)
Collectively, over the course of their careers, the tech-ops team members have published 250 papers in peer reviewed journals and have been issued over 75 patents.

The good measure of our reliability is the total number of patents that we have commercialized: more than two a year for 10 years

Unit also has developed a number of innovative tests, especially those with a stability accent, through the utilization of our extensive organic expertise and our collegiate collaborations

We have a fully integrated analytical lab, capable of method development and validation to ICH standards see….

Deliverables/Projects

Small scale custom synthesis* of organic compound/contract research (non GMP)
for the pharmaceutical, drug discovery, agrochemical

Syntheses per customer protocol
Syntheses per own pathways
developing and optimizing existing processes (solvent, catalyst, steps)

One or more chemists will be assigned to the projects full-time. You will receive a weekly update and are invited to add ideas, comments, and to interact with our chemists. The update may often be followed by phone conferences. Samples of intermediate compounds are available upon request at any stage of the synthesis. Upon completion of the project, B/N will provide a report on the R&D conducted on the project. 

Turn Around Times

Cut-off date of project may vary depending on the workability. (Non-standardized services) The costs of studies generally vary depending on the complexity. 
Confirmation needed for each client

DEPARTMENT OF RESEARCH AND DEVELOPMENT
New compounds, novel analogues, new patentable intellectual property

Case studies

  • A known pharmaceutical manufacturer experienced difficulties in optimizing own patented protocol for pilot drug trials. There was a poor understanding of the influence of different process parameters for chosen polymorph. Using the B/N novel simplified protocol the batches were processed in lots of 50kg.
  • X-ray patterns generated during a multiple solid form preparation of an antitrombotic occasionally showed unassigned peak. Subsequent stressing of the material generated the new X-ray pattern. This observation provides the basis for experimental approaches to give rise to a new crystalline polymorph.
  • A salt of antitrombotic formed two modifications. The unseeded crystallization irregularly yields the new unstable forms as impurities. The standard material and seed of new forms were prepared. The amount of seed, rate of cooling, and speed of work-up were optimized for regularly salt preparation.
  • Separation of the enantiomers of antiulcer compound using esters of thereof with chiral organic acids such as mandelic acid was published. The task was to develop a technique to which can be applied on an industrial scale. It was decided to use an optical resolution process wherein the diastereomeric pair is prepared by reactions cinchona quat under homogeneous conditions.
  • The formation of N-anion from N-alkanoyl valinate was the crucial step for N alkylation. The strong bases do not react as efficiently below 0°C and at ambient temperature concurrent inappropriate reactions occur. The best base was P4 phosphazene base, which is probably the strongest one, but it cannot be used in practical synthesis. A convenient compromise is the usage of sodium hydride, which reacts only as the base. The best results were achieved under kinetically formed N-anion in ultrasound bath followed by immediate alkylation.
  • New formulations of ibuprofen in various polyethyleneglycols as a carrier with anoionic or nonionic surfactant and various ingredients were prepared by known manufacturer. The stability studies showed interaction of drug and formation of unknown impurity. At the model stress tests/LC MS studies an impurity was generated in higher content. Compound was isolated and characterized. The alternative formulation was developed.
  • The new processes for the preparation of substituted biphenyl imidazole compounds were developed. Stable o-cyanophenyl fluoro borates were found useful in the key step of the Suzuki cross-coupling reaction provides valuable intermediate.
  • New forms of cholinesteraze re-activators with better dissolution properties were developed for application in dry wet/autoinjectors.