Many industries are at the cusp of change as technology continues to grow, introducing new tools that can significantly impact people’s health. Similarly, biotechnology is becoming a larger part of the pharmaceutical industry, thus impacting regulatory requirements.
Individuals keen on developing a stronger understanding of these requirements can explore the field of regulatory affairs—studying a wide range of regulations and standards, including regulatory legislation and practices, that shape the development and quality of pharmaceutical goods. This includes biologics and biotechnology products, like CRISPR, which have the power to change the future of the pharmaceutical industry.
Read on to discover how CRISPR is pushing the field of biotechnology to a new level, creating new considerations for professionals in regulatory affairs.
A Brief Overview of CRISPR: Its Applications and Advantages
CRISPR is a gene editing technique that has developed a quick reputation, providing new possibilities to treat genetic disorders and diseases. It stands for Clustered Regularly Interspaced Short Palindromic Repeats, describing patterns found in the DNA of bacteria and other microorganisms. These patterns are part of the bacteria’s immune response, which can be used to detect the genome of an invading virus.
With this technology, scientists can revolutionize gene therapy—targeting genetically-defined diseases as a way to promote human health. Unlike past gene editing techniques, CRISPR allows scientists to work more quickly and efficiently, using the CRISPR Cas9 protein instead of needing to create a gene editing protein from start to finish. This protein could then be matched with a guide RNA molecule (acting as a template structure) to help cut the DNA. Below are some ways how CRISPR can be used across different industries:
- Boosting the immunity of useful bacteria to improve food sustainability (i.e. dairy products)
- Enhancing precision in research to allow scientists to better study diseases and treatments
- Medical applications targeting mutant genes to cure heritable diseases in living organisms
Exploring New Opportunities and Considerations for Students in Regulatory Affairs
CRISPR/Cas 9 has introduced a wide range of opportunities in the field of biotechnology. Scientists have uncovered new potential for CRISPR/Cas 9 as a drug discovery tool. That’s because it allows researchers to study specific genes, giving them the ability to determine new targets for potential drugs. This development can influence the drug discovery process at various stages, including target identification and validation as well as preclinical testing.
Students taking Regulatory Affairs courses may be interested to know about gene therapy regulations. According to this study, Health Canada regards gene therapy products as drugs—falling under the Food and Drug regulations. However, they must also follow CTO (Cells, Tissues, and Organs) Regulations as well as ICH (International Council for Harmonisation) guidelines on safety testing. As research continues to show promise, regulations in this field become increasingly more relevant.
Notable Concepts that Can Impact the Future of Biotechnology Regulations
New technology often introduces new concerns and challenges. In this case, safety and ethics are key concepts that need to be further explored—likely affecting existing and future regulatory affairs. Although gene therapy holds promise, the treatments are still being researched and developed. This makes it a growing field, where opportunities and new developments can continue to revolutionize drug discovery and development.
Biotechnology has many implications, but continues to rise in popularity. CRISPR/Cas 9 makes gene therapy research more accessible to researchers. As such, more companies and start-ups around the world are exploring this field seeking to discover new opportunities and treatments.
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