ScinoPharm Taiwan Ltd. required a structural assessment of the disulfide bridges in various Linaclotide samples.
ScinoPharm Taiwan Ltd. is a leading process R&D and API manufacturing service provider to the global pharmaceutical industry. With cGMP production facilities, ScinoPharm offers a wide portfolio of services ranging from custom synthesis for early phase pharmaceutical activities to brand companies as well as APIs for the generic industry.
The determination of S-S bridges in such samples can be a challenging project, starting with the difficulties associated with fragmenting such a tightly bound structure. BioPharmaSpec scientists have considerable experience in analyzing complex disulfide bridge patterns and have supported several Linaclotide development projects.
Initially, BioPharmaSpec performed a full assessment of a representative sample to determine the disulfide-bridged structure. The analysis comprised:
- On line Liquid Chromatography with Electrospray-Mass Spectrometric detection (LC/ES-MS, Q-TOF)) of the representative sample (plus MSe and MS/MS as required).
- Collection of fractions of interest for further analysis.
- Further analysis of the fraction following sequential removal of amino acids and/or enzymatic digestion.
Technical Considerations- Disulfide Bridges
Our expert scientists are skilled in the implementation, analysis and interpretation of disulfide bridge patterns and can use this knowledge to provide you with a detailed assessment of your product’s free sulfhydryl groups and disulfide bridges.
Care must be taken when digesting proteins containing free thiols as the free thiol can initiate scrambling within the digest and the result obtained may not be consistent with the true disulfide bridge/free thiol pattern within the product. Using a range of techniques from LC-MS, LC-MS/MS through to Nanospray, BioPharmaSpec can determine the disulfide bridge pattern in your product to the fullest extent possible.
“We selected BioPharmaSpec as our partner in this project because of the previous experience they have with Linaclotide. It also instilled further confidence to learn of the contributions BioPharmaSpec scientists have made in the field of disulfide bridge characterization. ” –Scientist, ScinoPharm Taiwan Ltd.