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R&D Case Studies

There are various factors associated with success or failure of R&D projects, such as maturity of the technology, circumstances surrounding R&D systems within companies, environments for commercialization, and so on.

SiliCycle is truly concerned to make sure that your R&D project will be successful and not a waste of time and money.
We follow very clear and precise guidelines for streamlining the success factors and proper management of your project. With us, you are ensured that your project will be managed efficiently, expeditiously, and, above all, with extreme scientific rigor.

 

Custom Phase Synthesis & Method Development for Small Oncology Start-Up

« SiliCycle was able to manufacture and deliver a 5 kg PFP cartridge for use in our preparative separation in less than three weeks. This was key to our purification of our API. The results were excellent. »

This company synthesizes imaging agents that are very difficult to purify and they needed to step-up their production for trials.

Problem:
Molecule was highly polar and not very soluble. Standard C18 columns gave inadequate recovery and purity.

Proposal:
Screen different phases and optimize the separation for larger scale.

Solution:
Developed a custom Si-PFP phase that gave purities higher than 99.4 % with very good recoveries.

Results:
The PFP phase was adapted and packed into a 5 kg cartridge and the customer was able to purify the desired amount. At this time, these analytical columns are used for method validation.

 

Impurity Determination for a Generic Drug Manufacturer

« Thank you very much to everyone at SiliCycle ! We really appreciate the quality of your work and we will need your expertise for another project. »

This company produces a ready-to-inject generic drug. The non-generic version is a powder that is solubilized just before injection.

Problem:
There was an impurity that is generated in this generic version that was absent in the non-generic one. Rapid identification and quantification of this impurity was mandatory. This contract had been given to at least one other lab without success.

Proposal:
Isolate the impurity to determine its nature and then produce enough of it to product standards for quantification.

Solution:
We were able to isolate the compound even though it was unstable at room temperature and the desired amount was produced.

Results:
We were able to find a way to purify the compound at low temperature by chromatography and then use lyophilisation to remove the solvent without the compound deteriorating. The method developed is robust and was validated inhouse.

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  1. SiliCycle R&D Services brochure

    SiliCycle R&D Services

    Brochure (8 pages) - Introduction to SiliCycle's Research and Development services.

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