Extractables and Leachables

VelaLabs also offers characterization of Extractables and Leachables (E&L) components from the primary packaging materials of (bio-) pharmaceuticals and biosimilars.

 

Extractables are investigated during material characterisation and during selection of different primary packaging materials. Leachable studies are required for market authorisation as compounds that have leached from the primary packaging material into the drug product must be investigated.

 

Via the combination of gas chromatography mass spectrometry (GC-MS) and high resolution liquid chromatography quadrupole time-of-flight (Q-TOF), and liquid chromatography mass spectrometry (LC-MS) we are implementing an orthogonal approach to ensure maximal coverage of volatile and non-volatile compounds. Unknown substances can be quantitated using an internal standard response method. For components where the levels exceed safety-relevant thresholds, additional structural information can be investigated to predict a possible structure. For specific analytes, absolute quantitation methods can be established and validated.

 

Objectives

Extractables

Accelerated Leachables

Leachables

selection of extractables to be monitored

selection of leachables to be monitored

relative quantitation using surrogate standards

worst case scenario

close to reality including reaction products with API

identification of leachables above the analytical evaluation threshold (toxicological evaluation required)

Strategy

solvent extraction of primary packaging material

storage of drug product at higher temperatures

storage of drug product for complete shelf life

 

 Market Authorization

 

Extractable and leachable studies of primary packaging material for final drug products will enable our clients to select the optimal packaging material(s) and demonstrate safety for complete shelf life.