Trends in the Biotechnology Industry

The Human Genome Project, a 13-year undertaking completed in 2003, marked the first time that the entire human genome was sequenced, and was a major breakthrough in biotechnology (National Human Genome Research Institute, 2024). In 2022 - just 19 years later - the Guinness World Record for fastest human genome sequencing was set with a time of just5 hours and 2 minutes, representing the unprecedented advances that have taken place in the field of biotechnology over the last few decades (Armitage, 2022). From a better understanding of the causes and potential treatments of diseases such as cancer, to improvements in farming and agriculture, biotechnology has had a significant impact on the world we live in today, and advancements continue to change the landscape of our understanding and abilities. In this article, I will explore three current and prevalent trends within the field, including the use of CRISPR-Cas9 for gene editing, 3D bioprinting for the creation of living tissues and organs, and AI and deep learning with AlphaFold to better understand the nature and implications of protein structure. As with many advancements, there are issues and challenges associated with biotechnology, and this article will explore some of the ethical concerns that arise from these technologies. Despite challenges, biotechnology is still a relatively young field and yet many fascinating and groundbreaking discoveries have already been brought forth. As technology and our understanding of biological mechanisms continue to grow at a rapid pace, we have only scratched the surface of the impact that biotechnology will have.

Emerging Technologies

CRISPR-Cas9

One of the most significant scientific advancements in recent history, the CRISPR/Cas9 gene editing system, has its roots in the field of biotechnology. CRISPR-Cas9, often shortened to just CRISPR, is a method for editing DNA that was originally discovered in bacteria and has since been repurposed by scientists to be used for modifying any type of DNA. CRISPR has made headlines in recent years due it’s potential applications of editing embryonic DNA to create “designer babies”, which brings with it a whole host of moral and ethical dilemmas, some of which will be more closely examined later in this paper (Knoppers & Kleiderman, 2019).

Another, more auspicious application of CRISPR technology that has had the scientific and medical communities excited in recent years is its ability to manipulate and edit mutated genes, which can in turn help to cure or prevent genetic diseases such as cancer and cystic fibrosis, among many others (Mansour & El-Khatib, 2023). Although previous methods for editing DNA were possible, they were much less precise and much more time consuming and expensive than CRISPR, which opens a plethora of new and exciting opportunities in this field.

3D Bioprinting

Another topic that is at the forefront of advancement in biotechnology is three-dimensional bioprinting, a method that has the potential to completely alter the field of regenerative medicine. 3-D bioprinting involves the use of specialized 3-D printers and a bio ink, which contains living cells along with structural components, enabling the construction of new, living tissues and even entire organs from scratch (Leberfinger et al., 2019). This method has immense potential in the medical field. For example, organs could be fabricated for a patient in need of a transplant using living cells from the patient's own body, ensuring that the transplant will not be rejected (Leberfinger et al., 2019). While bioprinting has been proven to be viable through several studies, scientists are not yet at the point of creating entire organs through this method. There are still numerous obstacles to overcome to make this application a reality, but great strides have been made in recent years regarding 3-D bioprinting.

The basis of 3-D bioprinting goes back to 1986, with the first bioprinter being created in 2000 from a regular inkjet printer that was modified to use bio ink (Leberfinger et al., 2019). Since then, bioprinting has been used in various applications, such as “drug screening, drug/gene and biomolecule delivery, disease modeling, regenerative medicine, and biohybrid robotics” (Singh et al., 2020). Research has even been started on “in situ” bioprinting, which refers to printing cells directly onto live tissue. Essentially, this method could be used to “print” skin, bone, cartilage, or other types of cells directly onto an affected area of a patient, thereby circumventing the need to fabricate these tissues in a lab and then transplant them onto the patient (Singh et al., 2020).

One of the main issues with 3-D bioprinting, whether in vitro (in a laboratory setting) or in situ (directly onto a living organism) is the sheer complexity of biological material. For example, even within one organ, there are many different types of cells, varying levels of density throughout different areas of the organ, and incorporation of blood vessels and nerves into the structure (Leberfinger et al., 2019). Despite this, advancement in technology, including commercially available bioprinters and varying types of bioprinting technologies, show an extremely promising future for this amazing method. Leberfinger et al. even predict that, at the current rate of discovery and advancement, it will be possible to use this technology to fabricate full organs within the next decade (2019). This is an incredible example of the biotechnology field helping to push forward ideas and advancements that one day will revolutionize such treatments as skin grafts and organ transplants.

AlphaFold

The final trend this paper will explore relates to a groundbreaking development that has only recently been made possible due to advancements in machine learning and artificial intelligence. AlphaFold is an AI-powered program which can predict the 3-dimensional structure of proteins with astonishing accuracy (Perrakis & Sixma, 2021). While this trend may not at first seem as exciting or “sci-fi” as editing DNA or printing live tissue, its potential is tremendous. In fact, the three scientists in charge of the AlphaFold project at Google DeepMind received the Nobel prize in chemistry for their part in the development of this program (Callaway, 2024a). Although AlphaFold is still relatively new, there have already been several iterations of the program, each with new updates that have astounded the scientific community and opened doors for future research and applications of the findings that have been made available.

The main function of AlphaFold is to predict the structure of proteins, which are at the core of almost every biological function. Proteins are composed of long strings of amino acids which determine how the protein folds into a 3-D structure, and this structure is intrinsic to how the protein functions. However, until the release of AlphaFold in 2020, the methods for identifying these structures were very time and money intensive (Perrakis & Sixma, 2021). The ability for AlphaFold to quickly and accurately predict the shape of proteins is so astonishing that many scientists in the industry did not believe that this leap would have been possible for years, or even decades (Perrakis & Sixma, 2021). This advancement has particularly promising potential in the pharmaceutical industry.

By understanding the form and function of proteins through the application of AlphaFold, it is possible to better predict how certain chemicals and drugs will interact with these proteins and what effects they will have (Callaway, 2024b). AlphaFold is even helping scientists and researchers to design their own, brand-new proteins for medical application (Callaway, 2024a). For example, a recent protein design challenge sought to discover a protein which would help to control an overactive growth hormone receptor which has implications in cancer (Callaway, 2024a). The potential for AlphaFold to be used in the application of drug creation and protein design is extremely exciting and will provide opportunities that were previously thought to be impossible.

An Important Emerging Issue

Although the advancements discussed in this paper thus far are very exciting for both the scientific and medical communities, it is important to recognize the fact that certain dangers and potential for misuse come with these advancements. Of course, this is nothing new regarding significant and unprecedented leaps in scientific and technologic knowledge and application. As previously mentioned, many scientists and researchers hold their own misgivings about the potential uses of CRISPR and the unprecedented power that comes with it. As mentioned by Knoppers & Kleiderman (2019), this current ethical crisis mirrors in many ways the first uses of IVF, or in vitro fertilization, that occurred in the 1970’s. While some expounded the virtues of this new discovery and its implications for negating fertility issues, others exercised much more caution in the acceptance of IVF. A similar discourse is occurring now regarding the gene-editing capabilities of CRISPR (Knoppers & Kleiderman, 2019). This portion of the paper will explore some of the main moral and ethical concerns surrounding this subject, as well as the most prevalent ideas about safeguards and protocols for ethical practice.

Is CRISPR Really Safe?

CRISPR is the most accurate, versatile, and - while still being incredibly complex - simplest form of gene editing that scientists currently have at their disposal (Brokowski & Adli, 2019). Due to these facts, multiple studies involving CRISPR have already been published, including at least 15 clinical trials for CRISPR to edit disease causing genes (Brokowski & Adli, 2019). Understandably, this whole-hearted acceptance of a technology that many think should be tested much more is often regarded as irresponsible. One example of an effect of CRISPR treatment that is still far from being fully understood is known as off-target effects. Off-target effects are caused in large part by the sheer, overwhelming complexity of gene and protein interactions. In a study related to Parkinson’s disease, researchers found that editing a specific gene did indeed reduce Parkinson’s symptoms but also reduced the ability for certain neurons to effectively communicate with each other, which could give rise to its own series of unintended side effects (Mansour & El-Khatib, 2023). This is a prime example of why some professionals are skeptical about the widespread use of a system that, in their eyes, is not ready for the mainstream, and is in some cases being pushed forward too rapidly with too little understanding of its implications and true level of safety.

Moral and Ethical Concerns With CRISPR

Aside from discussions about whether CRISPR/Cas-9 is truly ready for all the attention it is getting, ongoing conversations are occurring about the uses of CRISPR, and what measures need to be taken as it becomes more widely used. For example, multinational meetings including many of the top minds in the field have occurred over the past decade and some agreements seem to have been made (Brokowski & Adli, 2019). The editing of germ cells, for example, which are reproductive cells capable of passing genes and traits to offspring, has essentially been banned unless very specific extenuating circumstances apply (Brokowski & Adli, 2019). The editing of embryos to produce “CRISPR babies” is also a very divisive topic with moral and ethical implications that have been debated since at least 2018, when a scientist in China edited the DNA of two embryos with the goal of making them resistant to HIV. This experiment came under scrutiny from the scientific community for not being “scientifically validated or peer-reviewed" (Knoppers & Kleiderman, 2019). This example has helped to shed further light on the fact that clear and effective policies and procedures must be agreed upon by the scientific community and upheld to ensure moral and ethical missteps do not continue to occur.

Conclusion

Despite the fact that CRISPR has not had a clear path forward and that many valid concerns have arisen regarding the practice, it is promising to note that steps are being taken to ensure best practices are upheld and used with this extremely powerful tool. From curing and preventing disease, to altering embryonic DNA to achieve “preferred traits”, the potential use cases of CRISPR are broad and fall along a spectrum ranging from the potential to save millions of lives, to being morally bereft in the wrong hands. As technology advances along with our understanding of the genome, it will be of critical importance to stay ahead of the quickly changing landscape of biotechnology with the goal of creating new methods which can benefit all of humanity. After all, many great advancements have faced challenges and issues when first introduced and have gone on to change the world for the better. With CRISPR, we are almost certainly on the precipice of another.