Biopharmacutical Distribution

We are living in a time of rapid technology growth in the development of pharmaceuticals.   One of the most important emerging technologies is in the area of “bio-pharmaceuticals”  which are essentially therapies in which the drugs are very complex molecules that either are direct replacements or mimic actions of essential functions in the body.   The hormone Insulin is one early example of this, however the science of bio-pharma is progressing rapidly,  to the point that DNA modification therapies delivered through custom virus carriers,  protein replacement therapies and other hormone replacement therapies are considered viable.

Top 10 Biopharmaceutical Companies ($bil)
01 Amgen $14,687
02 Genentech $10,531
03 Novo Nordisk $8,989
04 Merck Serono $7,338
05 Baxter BioScience $5,308
06 Biogen Idec $3,968
07 Genzyme* $3,751
08 CSL Ltd.* $2,961
09 Allergan* $1,311
10 Alexion Pharma* $259

Remarkably, one of the fundamental limitations of Bio-pharmaceuticals is that they can be extremely sensitive to the environment.   They can break down completely if exposed to excessive heat, and they degrade much faster than regular drugs even if stored at standard room temperature.   The problem then becomes distribution – how to ensure that the drugs can be delivered world-wide, even into impoverished, difficult-to access areas and still maintain the efficacy of the medications.

Currently, many of the biopharmaceuticals are stored and transported surrounded by dry ice (solid CO2) which keeps the temperature at around -60 C.  However there are problems. First, these ice packs typically last only a few days. Second, CO2 is considered a dangerous substance by the airlines, and transportation is carefully controlled.  Attempting to distribute drugs using this technique into remote areas is not easy, and there is thus an opportunity to develop an alternative.

One approach is to use thermoelectric coolers to replace the CO2 With coolers run by batteries, one could develop systems that last longer without generating any exhaust.   However, the real innovation comes with recognizing that the transportation and packaging problem needs to be coupled with how the dosages are packaged.  Typically a dose is packaged in a glass vial that is designed to be directly attached to a hypodermic needle.  The vials are then surrounded by shock resistant materials and outer layer packaging is applied.  On top of this,  the coolant system is overlaid.    This approach suffers from requiring a high volume of packing material compared to a relatively low volume of content.    A number of improvements are envisioned.  First, dosages are frozen individually in squares and stacked,  covered with a wrap.  Second, the dosages are concentrated to reduce water content and thus reduce weight and volume.  Third, thermoelectric coolers are used to keep the stacks cool at the dosage level.  At the treatment location, the frozen dose squares are transferred to a syringe using a small tool that extracts the dose in a sterile process.    This provides a low cost and convenient method of transporting the medications and makes worldwide distribution of biopharmaceuticals practical.

For more information contact steven <dot> warwick <at> innovationscommercialization <dot> com