Expert Solutions in Analytical Method Development and Validation

Expert Solutions to these Challenging Scenarios

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:

 

  • Velesco created a drug product extraction and HPLC method that encompassed the whole dose range.
  • A successful dissolution method was developed using surfactants.
  • 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:

 

  • Client outsourced analytical development to a small CRO, where analysis of one component proved challenging.
  • Velesco's analytical scientists identified an appropriate method in less than one week and transferred it to the CRO.