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 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 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 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 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, Toxikon* 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.  


Click image to download

Contact:


Dr. Piet Christiaens
Scientific Director

pchristiaens@nelsonlabs.com

Nelson Labs Europe | Organic Synthesis Services