FAST-TRACKING PRODUCTION OF BIOLOGICS: A PROCESS OF THE FUTURE
Deepakshi Kasat
During this covid-19 pandemic, the world has come to recognize biotechnology and its potential.
However, we are so used to equipping ourselves with one click-solutions, that waiting for a vaccine
is becoming increasingly difficult. With scientists around the world working tirelessly to fast-track
this process for us, we have taken for granted the timeline that goes into development of a
biological product. There are billions of lives at stake when a biological product of such urgent
need is introduced in the world. We are literally using future’s research to control the present crisis.
This article introduces biologics and their development and underscores why the current biotech
industry is raw and brutal.
The process of drug development spans 5 extensive steps
1. discovery and development
2. preclinical research
3. clinical research
4. FDA review
5. FDA post market safety monitoring
From in-vitro, in-vivo, animal testing to multiple phases of human clinical trials, the complexity
of releasing the final product to the consumer has increased manifolds over the past 50 years. With
over a billion-dollar monetary investment and research spread across 12-15 years, the risk of your
drug failing persists even after consumers use it. Moreover, getting monopoly over the market as
a blockbuster drug before your competitors launch their replica is another ball game altogether.
And yet, this remains the story of conventional drugs synthesized by chemical means. Biologics,
on the other hand, are composed of complex combinations of these proteins, nucleic acids and
sugars, or may be living entities such as cells and tissues. Isolated from humans, animals or
microorganisms, they are produced using complex biotechnology tools or cutting-edge
technology. Gene-based and cellular biologics are often at the forefront of bioengineering research
and provide treatments for complex medical conditions. Basically, they are much more
complicated to develop, with unpredictable susceptibilities to different populations and rigorous
in terms of money and research.
They have a wide product range- monoclonal antibodies, therapeutic vaccines, blood transfusion
products, gene and cell therapies- medicines of the future indeed. With increased understanding of
genetic bases and protein interactions, novel targeted therapeutic approaches can be employed to
combat the bigger players in the disease arena. The first biologic, genetically engineered synthetic
human insulin, marketed in 1982 opened doors to an entire new industry- biopharma.
Moreover, manufacturing complexities of biologics are major. With their ultra-sensitive nature to
temperature, pH, co-factors and cellular conditions- not only their production but also
administration becomes critical and tedious. Clinical studies aren’t as straightforward as for
conventional drugs. Their safety, purity and potency need to be verified with more scrutiny.
Diving back to the vaccine we need- it is yet another product synonymous to a biologic. Despite
already going extensive research in genetic engineering, bioinformatics, molecular targeting- any
biological product is limited by its complexity and novelty. Moreover, we are developing a novel
product for an entirely novel organism. It is a long and costly endeavor with low success rates- in
a fairly new industry. The industry is doing their work to compress a 15+ year long and rigorous
process into a one-year project. It’s time we do ours of being patient and supportive.
Reference (Jul-20-E1)
