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Creating ethically acceptable products for all

The sequencing of the human genome has ushered a renaissance in biotechnology. Our understanding of genetic information and advancements in biotechnology are creating therapies and vaccines that will transform pharmaceuticals and health care. Many of these products are developed and/or manufactured using ethically objectionable cell lines harvested from aborted fetal tissue.

Agathos Biologics is on a mission to create ethically acceptable products so that everyone—researchers, physicians, and ultimately patients—can benefit from these novel technologies without compromising their moral beliefs.

Background and history of cell Lines for biological research and manufacturing

The sequencing of the human genome was declared complete on April 14, 20031, two years earlier than planned, and was a watershed event in biotechnology. Given that the sequencing of the human genome provided the ability to “read” genes of a patient, one might say that the first direct therapeutic benefit would be the creation of a therapy that “wrote” a gene to correct a defect. This concept of “gene therapy” long predated the human genome project, but the project certainly accelerated its progress. The first gene therapy approved in the Western world was Glybera in July 2012. Glybera, using an engineered virus as a vector, delivered the gene for the enzyme lipoprotein lipase to the cells of patients with lipoprotein lipase deficiency, a genetic disorder in which a person has a defective gene for the enzyme. Although it is no longer marketed and was not a commercial success, it led the way to subsequent gene therapies that are treating diseases including cancer, inherited retinal dystrophies, and spinal muscular atrophy. Gene therapy has, in a real way, made “the blind see and the lame walk” (Matthew 11:5).

Biological factories

Viral vector gene therapies, as well as other biologics and vaccines, are produced in living cells.

Often these “biological factories” are human cells that were obtained from a living or recently deceased person. Perhaps the most well-known human cell line, HeLa, was obtained from the cervical cancer cells of Henrietta Lacks in 1951 and is the subject of a book2 and HBO film. HeLa is the most used cell line in biotechnology research and, although it is not used in biomanufacturing, other cell lines derived from human tissue are. A cell line based on human embryonic kidney tissue, HEK293, is “second only to HeLa in the frequency of their use in cell biology”3 and is used to manufacture marketed drugs including LUXTURNA and ZOLGENSMA. HEK293 is used to manufacture the AstraZeneca COVID-19 vaccine and PER.C6, a cell line based on human embryonic retina tissue, is used to manufacture the Johnson and Johnson COVID-19 vaccine4. Use of human-derived cell lines have provided great benefit to patients and are an essential part of pharmaceutical development and production.

The use of aborted fetal tissue in biotechnology research and manufacturing raises significant ethical concerns

It is ironic that the Bible claims Jesus’ ability to make the blind see and the lame walk is through divine power while biotechnology’s ability to do the same by using cell lines such as HEK293 and PER.C6 rests on immoral acts: these cell lines were obtained from electively aborted fetuses5 Although these cells were procured more than 40 years ago, the general practice of harvesting tissues and cells from aborted fetuses continues unabated. Aborted fetal cells are routinely used from early discovery research to manufacturing, and many experiments require “fresh” cells, ensuring the practice will continue. Decisions on what cell lines to use are often based upon performance, economics, or simple convenience, without regard to their source or the consequences of their use.

The use of aborted fetal tissue in biotechnology research and manufacturing raises significant ethical concerns for many people. All involved in the lifecycle of biotechnology development—researchers conducting early experiments, physicians leading clinical trials, employees involved in manufacturing, selling, and distribution, and ultimately patients and consumers—are forced to make decisions that may conflict with their strongly held moral beliefs. Recently the United States Council of Catholic Bishops (USCCB) advised the nation’s 70 million Catholics to choose the Moderna or Pfizer/BioNTech COVID-19 vaccine over the AstraZeneca vaccine based on the use of aborted fetal cells to manufacture the latter6. Unless this situation is addressed ethically compromised products will continue to present a moral dilemma and cause grave concerns.

Individuals who are passionate about an issue and are fortunate to have freedom and resources must act

Seek to effect change

When faced with moral issues there are many approaches one can take to effect change. Organizations like the Susan B. Anthony List and their research arm, the Charlotte Lozier Institute, seek to effect change through the political process and education. Citizens can make their voices heard by voting, lobbying politicians, making purchasing decisions based on their moral beliefs, and informing companies and other organizations that participate in unethical behavior of their concerns. The freedom we enjoy in this country allows us to do such things, and this freedom combined with the most successful economic system in history, market-based capitalism, enables entrepreneurs to start companies for any reason they desire. The existence of all companies depends on their ability to provide goods and services people want, but the reasons companies are created are as varied as the individuals who create them.

References and sources

  1. Human Genome Project FAQ. National Human Genome Institute web site https://www.genome.gov/human-genome-project/Completion-FAQ (2020).
  2. Skloot, R. The Immortal Life of Henrietta Lacks. (Crown/Random House, 2010).
  3. Lin, Y.-C. et al. Genome dynamics of the human embryonic kidney 293 lineage in response to cell biology manipulations. Nat Commun 5, 4767 (2014).
  4. Prentice, D. & Sanders, T. What you need to know about the COVID-19 vaccines. Charlotte Lozier Institute web site https://lozierinstitute.org/what-you-need-to-know-about-the-covid-19-vaccine/ (2021).
  5. US-FDA Meeting Transcript, FDA-CBER Vaccines and Related Biological Products Advisory Committee Transcript May 16, 2001. Wayback Archive of FDA web page https://wayback.archive-it.org/7993/20180125210145/https://www.fda.gov/ohrms/dockets/ac/01/transcripts/3750t1_01.pdf (2001).
  6. Moral Considerations Regarding the New COVID-19 Vaccines. United States Council of Catholic Bishops web site https://www.usccb.org/moral-considerations-covid-vaccines (2020).