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How to Face the Increasingly Emerged New Technologies in Biosimilars Industry

in Health / Diagnosis by Creative Diagnostics on 12/16/2014

Standing on the point of demand, aging population has been increased and become a serious issue for many developed countries. With the growing prevalence of “Western” diseases, global access to pharmaceuticals has seen a dramatic growth. While standing on the point of supply, increased competition has reached due to the emerging market players. Moreover, a shift in the way that drugs are developed, manufactured, and delivered has presented. Apart from the two sides, policy makers are facing dilemma. On one hand, they are struggling with a desire to provide improved access to better medicines, on the other hand working on the need to curb the growth of healthcare expenditures.

According to some statistics, worldwide sales of biologic drugs exceeded $169 billion in 2012 and it is predicated to exceed $221 billion in 2017. With biologics patent expirations and the push for personalized medication, the age of biosimilars is coming up.

During the past, we have historically relied on gene amplification to create productive cell lines; however, it leads to extensive variation and unpredictable stability of expression.  
Considering this, manufacturers are struggling between the traditional methods and emerging technologies. If the new technologies can provide greater reproducibility and speed, why won‘t we use it?
With development, the focus has turned to reliable and predicable product quality attributes, but not the maximum possible titres any more. New advances in this area for biosimilars, here we mention some, include:

? Alternative production hosts
? Alternate Expression Systems, such as CHO, E. coli, yeast, synthesis in transgenic animals and others
? Targeted genetic modifications
? Engineered expression vectors
? Host cell engineering
? Production technology, such as single-use technologies
? High throughput screening
? Purification Processing
? Rapid transient gene expression

Biosimilars are complicated, hard to characterize, typically have more than one biological effect, and frequently generate immune responses. Those we mentioned above are likely to be the next or (current) enablers of biosimilars in the eyes on researchers and scientists.
As we all know, the process defines the product, which tell us that the cell line development strategies will affect product equivalence and regulatory approval in terms of the biosimilars. By exploring and utilizing these new technologies, reviewing current animal-, yeast-, plant- or other based expression systems, predominant manufacturing technologies in the upstream and downstream, and essential quality attentions for developers and manufacturers of biosimilars—all pointing to the integration of these elements, therefore a comprehensively outlined drug development approach is important.


About The Author


Creative Diagnostics is the pioneer and undisputed global leader in the rapidly emerging market for biological testing services and biosimilars, also known as follow-on biologics (or biopharmaceuticals). We have developed a range of biosimilar stable cell lines using our proprietary gene screening and amplification system. Biosimilar cell lines are grown in suspension and produce high yields of recombinant proteins in chemically defined m




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