Pine Lake Laboratories is the scientific leader in extractables and leachables (E&L) studies. We have extensive experience executing the Biophorum (BPOG) Best Practice Guide for Extractables Testing of Polymeric Single-Use Components Used in Biopharmaceutical Manufacturing. We can perform the extraction as required by the BPOG protocol and aid the client in ensuring the proper experimental design.
Studies are designed to follow the BPOG protocol but can be adapted to meet specific client needs.
A toxicological risk evaluation of the extractable results can be performed by our staff toxicologists.
Our experienced scientific staff utilizes the following analytical methods for expert identification of extractables observed in a forced extraction study:
- Headspace GC-MS for identification of volatile organic extractables
- GC-MS for identification of semi-volatile organic extractables
- LC-QToF for identification of non-volatile organic extractables
- ICP-MS for identification of inorganic extractables
Our team has experience performing BPOG extraction studies on a variety of biopharmaceutical manufacturing single use components:
- Filters
- Bioreactor bags
- Flow cells
- Filling assemblies
- Tubing
- Tangential Flow Systems
- Storage vessels
