What are the Biotechnology applications, products, and record-breaking contributions to end the COVID pandemic?
What is Biotechnology?
The pandemic placed an unprecedented spotlight on the biopharma and biotech industries, as the world eagerly awaited the discovery, development, and roll-out of COVID vaccines and treatments to finally put an end to the global economic lockdowns and their devastating outcomes.
Although Biotechnology became a“household” term in 2020, many do not understand what the industry is based on, what it produces and what its far-reaching impact on our lives is.
Biotechnology uses living things, their parts, or processes to make products that improve human life. It is an active field of research and development, founded on the interaction between many scientific and non-scientific disciplines. Thus, the Biotechnology industry, including its real-world applications and careers, are multidisciplinary in nature. The industry is constantly growing and advancing as novel discoveries are made and innovative technologies emerge. It relies heavily on the applications of modern recombinant DNA technology and bio-manufacturing processes.
The “birth” of biotechnology generally dates back to 1972, when two scientists developed a modified DNA molecule by “recombining” DNA from two different organisms. This marked the advent of Recombinant DNA Technology. Prior to that, scientists were transferring DNA from one organism to another within the same species. In 1976, Genentech (BayArea, San Francisco) produced human insulin to treat diabetes using DNA technology and received FDA approval to sell the first biotech drug, human insulin, in 1982. It was produced by combining the human “insulin” gene with bacterial DNA (called plasmid) to produce recombinant DNA that was introduced into bacteria. These “genetically modified” bacteria divided rapidly in cell culture and produced insulin from the DNA instruction in the human gene that they received. This process of modifying DNA is also referred to as Genetic Engineering.
Learn about DNA and genes: https://learn.genetics.utah.edu/content/basics/dna
In the biotech industry, desired products are produced by Biomanufacturing, whereby they are purified up to 99.9 % purity, and packaged for marketing. In addition to the first biotech product, insulin, the biotech industry has successfully used recombinant DNA technology to manufacture human blood clotting factor, growth hormone, interferon, and many other therapeutic proteins and products. During the pandemic, recombinant DNA technology led to the discovery and development of COVID vaccines and therapeutics. Let us explore the diverse biotech applications and products.
What are the real-world applications and products of the Biotech industry?
Biotechnology applications and products touch every aspect of our daily life and can be summarized as follows:
1- MedicalBiotech: produces vaccines, therapeutics, and diagnostics. This includes COVID diagnostic tests, vaccines, and treatments.
2- AgriculturalBiotech: produces genetically modified animals and crop with improved traits.
3- DNA profiling: uses advanced DNA sequencing to create DNA profiles for crime scene analysis, paternity testing, ancestry, identification of genetic diseases, and victims of terror attacks or natural disasters.
4- Industrial Biotech: produces enzymes and proteins used in diverse industrial processes (textile industry, alternative fuels, food & beverage, etc.)
5- EnvironmentalBiotech: relies on bioremediation, which uses genetically modified organisms to clean up environmental hazards such as oil spills.
6- BiomedicalDevices: relies on the convergence of biology, chemistry, physics, engineering, computer technology, and nanotechnology. It involves many applications such as Regenerative Medicine to replace defective tissues and organs; Gene Therapy to treat genetic defects; and Artificial Joints.
7- DigitalHealth: intersection of digital technology, biology, and healthcare to develop wearable devices and apps to monitor health, telemedicine, and COVID contact tracing.
What are the record-breaking contributions of the Biotech Industry to mitigate and end the COVID Pandemic?
The Biotech industry raced to develop vaccines, therapeutics, and diagnostic tests to help mitigate and end the pandemic, as well as prepare for future pandemics. There are currently 3 approved COVID vaccines that received Emergency Use Authorization (EUA) from the FDA.
Two of these are novel RNA vaccines by Moderna and Pfizer. These use platforms that can be modified to address new mutations and emerging viral strains and are currently being modified to provide better protection to Omicron.
Biotech companies and research institutions across the globe raced to screen their libraries for drugs that can be repurposed to treat COVID patients. There are over 1,000 trials testing medicines previously approved for other indications (HIV, Ebola, other antiviral combinations). Remdesivir (sold under Veklury) was developed by Gilead to treat Hepatitis C, then subsequently Ebola, and was stockpiled in case of a reemerging Ebola pandemic. It was repurposed to treat COVID patients and received EUA for use in hospitalized patients who require oxygen.
In parallel to this repurposing effort, there are global efforts to research, discover and develop novel therapeutics for COVID, with over 1700 active global trials. Pfizer’s COVID oral treatment was approved by the FDA for emergency use. This at-home treatment is a potentially game-changing therapy and can be prescribed to high-risk patients,12 years of age and older, who tested positive, to potentially help them avoid severe illness and reduce hospitalizations and deaths. It is a protease inhibitor that blocks SARS-CoV-2 from cutting its long pro-protein into smaller proteins that get assembled into new viral particles, thus stopping viral replication inside host cells.
The FDA also granted EUA to several antibody therapies which include animal-sourced antibody therapies, blood-derived plasma and hyperimmune globulin containing antibodies from recovered COVID patients, in addition to antibodies manufactured by biotech companies through genetic engineering.
Biotech companies also raced to develop improved diagnostic tests that provide more accuracy, precision, and specificity. Currently there are rapid (Antigen) tests, RT-PCR tests, Antibody tests, and CRISPR SARS-CoV-2 tests (still under development).
The biotech industry also managed to scale up the production of these tests and vaccines to rapidly meet global needs. The transition from scientific research labs to manufacturing facilities is incredibly complex, as companies need to ensure consistency in vaccine composition, safety, and efficacy profiles. The issue of vaccines safety is a challenging undertaking, especially in less developed regions since vaccines often require special handling. Collaborations between Biopharmaceutical companies, local governments, NGO partners and research facilities were rapidly established to ensure safe distribution at a global scale.
One of the pressing questions that arose during the pandemic was how the biotech industry broke all records and was able to roll out COVID vaccines in less than 12 months. The fastest vaccine development process to date was in 2005, when the Ebola vaccine was developed in only 5 years. These record-breaking contributions sparked concerns about vaccine safety, leading to misinformation campaigns and conspiracy theories on social media and beyond questioning the safety and efficacy of vaccines.
But in fact, there are many factors that expedited vaccine development and roll out, many of them involving the use of innovative technologies such as rapid genome sequencing. TheSARS-CoV-2 genome was rapidly sequenced in 2 weeks, then analyzed and compared to viral sequences of MERS and SARS, two closely related common cold viruses of the same family that caused the SARS outbreak (2002) and the MERS outbreak (2013).Furthermore, viral protein structures were resolved very rapidly, which shed light on how the virus interacts with our immune system, how it infects and enters our cells, and how it hijacks them to produce more viral particles. Resolving viral protein structures significantly helped in identifying good targets for the development of vaccines and diagnostic tests. It also provided insight into the intricate and complex responses of our immune system and variations among the immune response of individuals based on genetic make-up, age, gender, underlying conditions and more. The rapid global spread of SARS-CoV-2 and the accompanying global shutdowns and resulting economic damage have all led to unprecedented international collaborations to coordinate partnerships between public, private, philanthropic organizations and the WHO to advance vaccine development platforms.
The rapid publishing of and open access to scientific data by established scientific journals have expedited COVID research and development. Using artificial Intelligence (AI) significantly sped up vaccine development approaches beyond the informed trial-and-error approach of humans. Biotech companies were willing to collaborate and initiate manufacturing capabilities at risk in parallel with clinical development before vaccine candidates received FDA approval.