The fine art of pharmaceutical analysis

There are numerous reasons why pharmaceutical companies at some point turn to an outsourcing solution provider. It can be a matter of streamlining operations, cutting time to market or reducing costs. Last but not least, outsourcing laboratory services is a quick and efficient way to gain access to special capabilities and expert knowledge.

Analytical service is no exception.

Now, let’s look at some of the issues and challenges that are significant for pharmaceutical analytical chemistry.

Characterization of a new active pharmaceutical ingredient, API, requires a battery of methods and techniques. To analyze how the very same API works, responds or degrades in a formulation, normally calls for a totally different toolbox.

Running an analysis on API alone is a quite straightforward operation because the sample is very pure. After formulation, on the other hand, the API must be extracted before it can be analyzed. This can sometimes be a rather tricky and time consuming operation, highly dependent on dosage form.

The chemical stability must be studied to determine, for instance, the expected shelf-life of the drug. To do so, samples must be taken, in which all of the API as well as all possible degradation products are accounted for with high accuracy.

All excipients have an impact on the API. A combination of two or more excipients can produce yet another response that will affect the stability or efficacy of the medication. Even though many APIs are similar and have common chemical traits, each and everyone require its own analysis. Likewise, any change in the mix of excipients may introduce new analytical challenges.

The fine art of pharmaceutical analysis is not so much a question of knowing what kind or how much of an API that goes into a formulation, but rather making sure that all of it always can be traced at any time.

A step closer to trials without errors

At some stages pharmaceutical research and development is a question of trial and error. But when it comes to clinical trials there is no room left for mistakes. Even the slightest suspicion of a mix-up of substances, documented results or test subjects can be reason enough to scrap an entire trial project, provoking great expenses as well as losses in time to market and reputation.

Consequently, there are continuous efforts in clinical trials supplies to make the handling safer and the logistics more reliable. The aim is to ensure that each site and each patient is supplied with the right medication, in the right quantity at the right time.

NEW: Packing and labeling
Risks can, of course, be reduced in many different ways. One way to enhance control and ease management concerns is simply by decreasing the number of players involved in the supply chain. As a part of this effort, we at Galenica recently decided to extend our offering to also include packaging and labeling of clinical trials supplies and we now fulfill all relevant regulatory standards and have acquired the necessary permissions.

Keeping some of the work stages within our own premises bring several improvements to the operations. Naturally, it is easier to supervise and control all details if the packaging and labeling process takes place in-house and can be executed in one single uninterrupted sequence. This is especially valuable if the trials are complex and distributed over both time and space.

Being able to avoid shipping to and from another Contract Research Organization in charge of packaging and/or labeling has several advantages. Not only will it decrease the risk of goods getting mixed-up or instructions being misunderstood. In addition, each transport means that the medicinal preparations will leave a closely monitored indoor climate and risk – by negligence, lack of judgment or bad luck – being exposed to cold, heat, humidity or careless handling.

These measures and procedures do not make our system absolutely foolproof, but it takes our clients one step closer to trials without errors.

Life Science Industry Award 2012

Galenica wins the City of Malmö Life Science Industry Award 2012.
The jury’s motivation:
“Since its inception in 1999 the company has developed positively, which has led to Galenica today being one of Europe’s most competent CROs focusing on galenic development. The company has now taken a step forward by developing its own products. The first product – a new and improved cream for the treatment of psoriasis and eczema – was recently launched.”

New product – from Galenica

Galenica AB has developed and is launching Ovixan®, a cream formulation for the treatment of psoriasis and eczema. The clinical development program has been successfully completed and the product was approved in all the Nordic countries during Q1 2012. The trade name (Ovixan, a prescription drug) has been registered and patents are pending. The new and improved cream preparation, which is indicated for both psoriasis and eczema, will offer a number of patient benefits compared to existing cream formulations leading to improved compliance. Galenica will launch the product in all the Nordic countries during 2012–13. For more information about Ovixan please see the ”SUMMARY OF PRODUCT CHARACTERISTICS” or Fass.se.