Differences Between a GMP and Non-GMP Lab – Part 1

Greetings! I was hired on with Velesco earlier this summer after several years of work in cGMP pharma labs, both contract and manufacturing-related. Coming from a cGMP (current Good Manufacturing Practices) background, I’ve noticed a few differences in the way the lab operates when not confined to GMP regulations.  In the next couple of posts, I will discuss these differences. Coming from cGMP...

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Formulating an Oral Suspension (part 2)

In part 1 of this article I described the need to ensure the delivery of a uniform dose of a suspension, how this can be achieved and the challenges that can be encountered.  In part 2 I’d like to discuss preserving against microbial growth, taste & “mouthfeel” and manufacturability.  Suppressing microbial growth Aqueous solutions containing viscosity modifying polymers and other...

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Formulating an Oral Suspension (part 1)

  Frequently we at Velesco are approached with a request to formulate a suspension of a new compound for use in a clinical study.  Often this request contains the helpful information “we mixed some drug with some 2% methylcellulose solution and dosed it to the rats without issues so this shouldn’t be a big job, right?” Well maybe yes but probably no is the answer to that. Formulating...

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Clinical Supplies Group Conference – Study Drug Returns and Reconciliation

A couple of weeks ago I attended and exhibited at the Global Clinical Supplies Group conference which was held at the wonderful Hyatt Regency Tamaya Resort & Spa in Santa Ana Pueblo NM . It was a great meeting with about 250 attendees who specialize in the co-ordination of clinical study supplies and thirty something exhibitors.  The meeting was very well organized by George Wills and...

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