Challenge:
Velesco was employed by Client #1 to troubleshoot and solve API extraction inconsistencies observed during stability studies for a Phase 3 drug product.
Velesco Solution:
- Velesco quickly determined the main cause for the inconsistent assay values observed and implemented straight forward solutions to provide consistent results.
- Velesco was additionally contracted by the client to develop and validate the Phase 3 drug product release and stability-indicating methods, as well as conduct dissolution testing in support of a waiver of in vivo bioavailability and bioequivalence studies.
- The methods were successfully transferred to the drug product manufacturer.
Challenge:
Client #2 needed a drug product release method for a very poorly soluble drug with a wide potential dosing range (300X).
Velesco Solution:
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Velesco created a drug product extraction and HPLC method that encompassed the whole dose range.
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A successful dissolution method was developed using surfactants.
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A stability program was undertaken and the client was able to file an IND with 8 week stability.
Challenge:
Client #3 is a virtual company developing a multi-component solid dosage form of existing products for a new indication.
Velesco Solution:
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Client outsourced analytical development to a small CRO, where analysis of one component proved challenging.
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Velesco's analytical scientists identified an appropriate method in less than one week and transferred it to the CRO.