Organic Synthesis Services

Organic Synthesis Services

 

Nelson Labs Europe, a Leading Lab in providing Extractables and Leachables Services for the Pharmaceutical Industry, is now offering a Full Suite of Organic Synthesis Services* to assist in the Scientific Quality and Subsequent Risk Assessment of Extractable and Leachable Studies. 

 

Why Organic Synthesis Services?

  • For many Polymer Impurities (Extractables or Leachables), no commercial standards are available.
  • Mass Spectral Interpretation of Compounds - either Manually or utilizing Commercial MS-Libraries - does not ensure correct Compound Identification.
  • Analytical Response factors of non-target Compounds are unknown. The result is a higher uncertainty factor considered in the Risk Assessment of Analytical Data.
  • For non-commercially available Compounds, basic toxicity data is often unavailable.

 

Benefits of using the Organic Synthesis Services?

  • Enables Unique Confirmation regarding the Identity of Compounds of Concern - of which no commercial standard is available - in “Second Pass” Extractable Testing.
  • Allows quantifying Leachables/Compounds of Concern with target compounds in hand.
  • Obtaining the Synthesized Compounds will also allow obtaining Toxicity Data in either in-vitro screening tests (e.g. AMES-Testing for Mutagenicity) or in-vivo toxicity tests for common Leachables
  • The Organic Synthesis Services will also be used to further develop the Proprietary Compound Screener Database Extractables Screener Database, used in the Identification of Extractables in “First Pass” experiments.
  • Organic Synthesis Services may be utilized to assess potential interaction between leachable compounds and API, Excipients, Adjuvants, Buffers,… present in the Drug Product.
  • Organic Synthesis Services can support any need for obtaining pure compound (even not related to E/L) such as API impurities, API-degradation compounds etc...

 

Current status of the Organic Synthesis Services?
For the last 5 years, Nelson Labs Europe has supported Customer Needs in Organic Synthesis for a broad range of applications, such as the Custom Synthesis in:

  • Extractable and Leachable research, synthesis of key Extractable / Leachable compounds which are not commercially available
  • Design and synthesis of small molecules and analogs for Lead Generation and Lead Optimization
  • Pharmacophore-based focused libraries generated for a particular target protein
  • Preparation of building blocks, scaffolds and intermediate compounds
  • Custom synthesis of lead compounds up to a kilogram
  • Metabolites identification, quantitation and Synthesis
  • Impurity profiling in API: Identification and Synthesis of Impurities
  • Synthesis of Selected API and their intermediates, for example: Prostaglandins and Pheromones in multi-gram scale
  • Scale up for preclinical drug candidates, pharmaceutical intermediates

 

More than 140 compounds have been synthesized so far, of which 20 compounds are related to extractables and leachables work. The E/L-compounds selected for Synthesis were Leachables observed as a result of Container/Closure-Drug Product Interaction. These compounds have been added to the Proprietary Compound Screener Database Extractables Screener Database, to assist in a unique Identification of Extractables or Leachables in “First Pass” experiments. Further synthesis of key Extractables / Leachables which are not commercially available is planned on an ongoing basis.  


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Contact:


Dr. Piet Christiaens
Scientific Director

pchristiaens@nelsonlabs.com

Nelson Labs Europe | Organic Synthesis Services