Market Niches

Over the past decade, there have been two main shifts in how the pharmaceutical industry views the improvement of itsR & D pipelines. Anthrocell has positioned itself to take advantage of this new market perspective.

Biologicals

In the last decade, the pharmaceutical industry started to shift its R & D pipeline from simple chemical-based compounds towards more sophisticated biologics-based compounds to address the growing need for management and treatment of complex and life-threatening diseases such as cancer, heart diseases and age-related illnesses.

According to IMS, the worldwide biologics market is estimated to be worth $120bn. Within this sector, Datamonitorforecasts that global sales of antibody-based therapeutics could reach $58bn by 2014. Not only is the number of biologics expanding, but the size of acquisitions is also growing with more cash offered up front.

Novel Expression Systems

The second significant industry shift relates to the need for improved expression systems when dealing with biologics. Biological products require living organisms to produce them. For the last 30 years nearly all biotherapeutic products were manufactured using three “classic” expression systems – E. coli (bacterial), yeast and CHO (mammalian). More importantly, mAbs could only be manufactured by using mammalian systems, with CHO cells representing 74 per cent of current mAbs on the market.

Many companies have ‘failed’ products on the shelves that could and should be made more efficiently and to higher clinical standards in newer expression systems. With glycoproteins manufactured in mammalian cell culture in particular, the use of different host cells and associated expression systems results in products with different glycosylation and other structural properties, pharmacological activity and toxicity, including immunogenicity.

Anthrocell’s Unique Proposition

Anthrocell’s technology overcomes most of the above-stated difficulties through the use of a human cell-based expression system. Our research has paved the way for high yield production of fully human mAbs. The glycosylation and other structural properties, pharmacological activity and immunogenicity of mAbs produced by our system correspond with those found naturally in our bodies, and thus toxicity becomes a relatively rare complication.

Of particular importance, correct glycosylation of mAbs is largely responsible for eliciting ADCC, which causes cells from the patient’s own immune system to be recruited to destroy cancer cells. In many instances this means that “cancer-slowing” mAbs acquire “cancer-killing” properties when produced using Anthrocell’s technology.