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Facts re: drug formulation, analytical development, GMP regulations | Velesco Pharma

FAQ

 Q:

 Does Velesco Pharmaceutical Services work with small or large molecules?

 

A:

Velesco's expertise is with small, synthetic molecules, as well as carbohydrates. However, our analytical method development scientists have the experience and the analytical laboratory testing equipment to undertake stability testing work with small peptides, up to proteins.

 

Q:

Are there any classes of compounds that Velesco Pharmaceutical Services is unable to work with?

 

A:

Velesco is not, at this time, licensed to work with radiolabeled materials or controlled substances.

 

In order to meet various quality guidelines and client requirements, Velesco Pharmaceutical Services does not handle penicillins or cephalosporins.

 

Our analytical testing laboratories are equipped with dust hoods that allow us to work with compounds having OELs as low as 10 mcg/ft3(eight-hour time weighted average). We understand that many of our clients having novel compounds do not have this safety data; therefore, for hormones, hormone antagonists, steroids and cytotoxic compounds are assessed individually by a consultant safety expert. Velesco pays for this consultation, even if the material is considered unsuitable for our analytical testing laboratory.

 

Q:

Does Velesco Pharmaceutical Services outsource work for which they do not have the necessary equipment?

 

A:

On those occasions when Velesco is tasked with specific tests for which we don't have the equipment on site (e.g. pXRD or NMR), we make use of our well developed pharmaceutical industry connections with the University of Michigan and other local service providers with whom we have confidentiality contracts.

 

Q:

Does Velesco Pharmaceutical Services perform GMP work?

 

A:

 

Yes, Velesco has a state-of-the-art GMP manufacturing facility in Western Michigan that allows us to provide packaged clinical supplies of non-sterile drug products. Our main focus is on supporting early phase studies with active pharmaceutical ingredient (API) in bottle or capsule, but other dosage forms such as simple topical preparations are also available.

 

From a laboratory perspective, we have the appropriate quality systems and a number of validated HPLCs to allow us to undertake GMP testing of materials.

 

 

News and Events

Pace® Life Sciences Acquires Velesco Pharmaceutical Services, Expanding Capabilities in Drug Development Services

Read the Press Release!


Dave Barnes, Ph.D. CEO/CSO is a featured speaker for the webinar Topical Formulation: Selection of Excipients and Better Process Understanding for Success in Commercial Manufacturing. Webinar recording available now.

View Recording!


Newly Acquired DEA Analytical Laboratory License. We are licensed to use schedules 2, 2N, 3, 3N, 4, and 5.


In this episode of Molecule to Market, you’ll go inside the outsourcing space of the global drug development sector with Gerry Cox, Founder and Chief Operating Officer at Velesco Pharmaceutical Services.


Roundtable: M&A trends in CDMO - Molecule to Market


New Velesco Pharma clinical manufacturing facility begins operations.

Read the press release here.


Lisa Crandall, MS, and Peter Angus, PhD, spoke with Pharmaceutical Technology about the best practices in stability testing.

Read the interview here.


Velesco has expanded our analytical facilities in a new Wixom, Michigan location with the help of the Bank of Ann Arbor Technology Industry Group.

Read the press release here.


CEO Dave Barnes has been published in a new Pharmoutsourcing article on Clinical Trial Materials and Manufacturing!


1 new job postings! Careers


Velesco's work published

Formulation Development & Manufacturing:
Using a Single Provider Reduces Costs & Risk
Read it here.


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