Pharma

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Biologics & Biosimilars

Spinnovation applies NMR and MS-based technologies to provide solutions to problems encountered during the research and development of biologics and biosimilars (peptides, proteins, oligo/polysaccharides, antibodies, nucleic acids). With our technology and expertise we can address very intricate problems dealing e.g. with impurity profiling, batch validation, absolute quantification of active component, stability / formulation, activity.

In April 2011, Spinnovation launched a division dedicated to "Biologics" to offer an innovative Spent Media Analysis service, Spedia-NMR™,  advanced Process Bioanalysis and Product Bioanalysis. For more information, visit our dedicated website www.spinnovation-biologics.com.


Among numerous other issues related to biologics, we have worked on the following projects and delivered:

  • A client needed to validate that a complex biological compound that they were developing was exactly bio-similar to a pre-existing compound, this, considering that the active structural motifs were the same. We developed a method to fingerprint the active moiety of the registered compound in different batches and compared it to the profiles of the new compound batches, thus confirming the equivalence of the structural motifs carrying the activity.
  • A biological API was suspected to be present in a much lower amount in different batches than initially specified by a supplier. For the client we developed and applied, a quantitative NMR-based method to establish the absolute concentration (w/w %) of the API, that delivered unambiguous experimental evidence close to initial expectations.
  • QC/QA specialists of a Pharma company were confronted with a recurrent impurity issue in batches of a complex biologic product. Despite their efforts, they were neither able to isolate nor to identify the impurity. We applied Spinnovation's expertise and methodologies to the problem and identified the impurity within 2 weeks. The impurity ID was further validated a few weeks later against a chemical standard.

 

Reference : Spinnovation collaborated with Merck Sharp & Dohme on the development of NMR assays for biologics.

 
 

Spinnovation Analytical is part of Sinensis Life Sciences

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