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Biopharmaceuticals vs. Pharmaceuticals

Pharmaceuticals

The traditional pharmaceutical market is well established and is dominated by ‘small molecules’.  Whilst the majority of the pharmaceuticals were derived from naturally occurring sources around 50 years ago, they are all constructed via well-defined synthetic chemical processes.  This controlled manufacturing process is well investigated, understood, tightly controlled, and finally validated such that the product is consistently and precisely produced.  This has allowed traditional pharmaceutical manufacture to be moved from one manufacturing unit to another in other cities, countries, and even continents.  As their broad classification suggests, traditional pharmaceuticals are small in size, typically 100-1500 Daltons, consist of a small number of reactive moieties, or functional groups, and are relatively stable, even under long term storage conditions.

Rosuvastatin

Figure 1: Typical small molecule pharmaceutical – Rosuvastatin MW 481.5 Da.


Biopharmaceuticals

Biopharmaceuticals, on the other hand, are much more complex and are genetically engineered from living cells.  They are larger than traditional small molecule pharmaceuticals encompassing a huge size range, from 2,000-2,000,000 Daltons, with the average size in the range 5,000-150,000 Daltons.

Insulin glargine

Figure 2: Typical ‘small’ biopharmaceutical – Insulin glargine (MW 6063 Da).

Adalimumab

Figure 3: Typical ‘large’ biopharmaceutical – Adalimumab (MW 144190.3 Da).

They possess hundreds of reactive moieties, commonly 10-2000, and are much less stable and more labile compared to their smaller counterparts. Due to their size, and in particular to their route of production, they are incredibly complex and consist of a mixture of closely related variants rather than a single specific entity.  Their size, complexity, lability and route of manufacture present a unique analytical challenge where multiple separations, encompassing multiple modes of chromatography, are common place right across their manufacturing procedure.

The cost of treatment is significantly greater too, where typical monthly costs of US$2,000/month for Humira (adalimumab) are around 30 times more expensive than the alternative small molecule Rheumatrex (methotrexate). [1]

Comparison between a typical pharmaceutical and biopharmaceutical

Figure 4: Comparison between a typical pharmaceutical and biopharmaceutical.

 
[1] The Pharmaceutical Journal, online http://www.pharmaceutical-journal.com/publications/previous-issues/cp-october-2014/forces-driving-the-evolution-of-biologics-into-biosimilars-and-biobetters/20067091.article
 
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