(Amherst, NH) – The ability to reproduce protein and peptide molecules via recombinant engineering is one of the great healthcare success stories of the past fifty years. These complex drugs now provide the basis of therapeutic care for a number of refractory ailments, a list that includes autoimmunity, inflammation, infectious virology, metabolic diseases and reproductive medicine.
The clinical application of these drugs is limited by instability at ambient temperatures and a lack of desirable attributes for adequate absorption or distribution. It therefore becomes critical to formulate these drugs into safe, stable and efficacious delivery systems. Because these drugs face formidable enzymatic and penetration barriers when administered orally, peptide and protein drugs are overwhelming developed and marketed for administration by injection.
The need for post-manufacturing engineering of protein and peptide drugs has led to a greater level of cooperation between drug developers and the formulators and device designers that bring the needed capabilities to fully productize biological drugs. This cooperation is occurring much earlier in the drug development cycle, allowing device designs in many cases to be tailored to the bioavailability targets and pharmacokinetic profiles of specific drug therapies.
The current list of approved therapeutic proteins will grow at an exponential rate as the convergence of automated drug discovery and biotechnology production methods create new biological drugs for an expanding number of diseases. In this climate, we expect the impressive success of therapeutic biologicals to continue their impressive growth, climbing from $54 billion in 2008 to more than $80 billion in 2012.
More information is available at http://www.greystoneassociates.org/Therapeutic_Proteins.htm
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Greystone Associates is a medical and healthcare technology consulting firm providing services in strategic planning, venture development, product commercialization, and technology and market assessment.