Excellence Speaks for Itself
In the highly competitive and confidential world of drug development, we understand the greatest testament to our expertise and service is from our clients themselves.
"Velesco is doing a great job; I'm pleased with how rapidly they are addressing our issues."
CSO, pharma company
"For our program, Velesco performed development work on a challenging analytical method to measure low levels of API and related substances in the presence of many interfering excipients. The project was handled expertly from start to finish. The outstanding features of Velesco’s service are their highly knowledgeable and responsive personnel who provide a very quick turnaround time between discussion and results. I highly recommend Velesco and plan to use their services in the future."
Director, Technical Operations, pharma company
"We are very happy with the results of the recently completed formulation project."
Director of CMC, pharma company
"David and his colleagues at Velesco are very professional scientists. We do not feel as though David and his colleagues are consultants, we feel they are partners that truly help in resolving issues."
Executive Director, pharma company
"David cracked the case for a formulation/analytics problem that had plagued a drug development company I was working with for months. Within a week of being brought on board he diagnosed the problem and found a solution that was immediately implementable to the manufacturing protocol. We were able to move forward with producing clinical trial materials which would have otherwise delayed the start of the study. It was truly a magical, rabbit-out-of-a-hat performance. Thanks David and Velesco!"
CEO, business consulting firm
Challenge:
Client #1 required a common formulation for a family of four compounds with control that employed a clear, water-based vehicle to increase topical bioavailability.
Velesco Solution:
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Within two days, Velesco developed a common formulation applicable to all five compounds to be dosed at three strengths each.
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All four compound formulations demonstrated significant improvement versus control.
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Timely delivery of the formulation allowed the client to meet their tight timelines for an animal study.
Challenge:
Client #2 had a poorly soluble compound which they needed in a vehicle acceptable for oral, i.p., and i.v. use.
Velesco Solution:
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Within one week, Velesco successfully developed a formulation that met the client's target concentration, was isotonic, well tolerated by the target animal species, and was acceptable for all three routes of administration.
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The formulation was simple to prepare and demonstrated 2 week stability at ambient storage.
Challenge:
Client #3 had a poorly soluble compound which they wanted formulated as a clear solution/microemulsion at high concentration for oral use in tox studies.
Velesco Solution:
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Within one day, Velesco developed a formulation that met the client's target concentration, was a lipid-based self-emulsifying drug delivery system (SEDDS), stable for three weeks at ambient storage, and had potential for further development as a soft-gel formulation.
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Client requested development of additional oil/water microemulsion formulations at high concentration. Velesco quickly developed two additional formulations to meet these requirements. The oil/water microemulsion also demonstrated good stability.
Challenge:
Client #4 had a poorly soluble, non-ionizable compound and required a high dose injectable formulation for animal studies.
Velesco Solution:
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Regular solvent mixtures were unable to achieve the required dose, but the precipitation characteristics suggested nucleation inhibitors may work.
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A successful non-toxic formulation containing anti-nucleation polymers was developed.
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A successful animal study was performed.
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 had a very poorly soluble drug with a wide potential dosing range (300X) and an API method.
Velesco Solution:
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Velesco modified the API method to halve the run time and created a drug product extraction method that would encompass the whole dose range.
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Surfactants were required to obtain sink conditions for dissolution testing.
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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 manufacture & 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.
Challenge:
A large pharma company outsourced the running of two significant clinical studies to a clinical CRO. The supplies for the studies were manufactured, packaged and distributed by three separate CROs. With tight deadlines and multiple vendors, Client #1 needed a system to manage the timely delivery of supplies.
Velesco Solution:
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Velesco worked with all five parties to identify critical points and milestones in the project and then put into place a system to manage and track the supplies. By using a combination of IT systems, regular meetings, and frequent one on one communication, Velesco ensured that issues were identified and resolved in a timely manner. All clinical timelines were met.
Challenge:
Client #2 identified a CRO with a technology that could improve solubility. Client's formulator left the company and vendor oversight was proving problematic especially when technical issues arose.
Velesco Solution:
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Velesco personnel now act as client's formulator/vendor oversight and have brought the project back on track, keeping both client and CRO aware of the other side's requirements.
