(This will be the central hub for the final project developed and presented at MIT´s HTGAA 2025 course.)
A collection of biologically-produced colorants, based on a pre-existing idea developed and presented as part of a Bio-business course. The project would include not only the pigment identification, selection and development. It would also deal with the cloning process, the choosing of ideal vectors, and the purification process.
Regulations
According to US data, the current revenue of the main target market (tattoo artists) is $1.5 bn, with an approximate yearly increase of 8% since 2007 (https://www.ibisworld.com/industry-statistics/market-size/tattoo-artists-united-states/). It´s tricky, because our customers are the tattoo artists, but we must also appeal to their own clientele, in the hopes they both seek out our product, be it for health, price, or artistic reasons.
Despite the practice of tattoo artistry being more or less regulated in different areas of the world (although not at the federal level in the US); currently, the regulation surrounding tattoo ink composition heavily varies depending on the area of the world.
For instance, in the US, the FDA has no regulation whatsoever on the composition of the pigments (https://www.karger.com/Article/Fulltext/369231), only having guidance for unsanitary conditions and microbial contamination https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-insanitary-conditions-preparation-packing-and-holding-tattoo-inks-and-risk. Meanwhile, different countries in Europe have different regulations, and the EU has banned compounds, such as Pigment Yellow 74 (https://www.karger.com/Article/Fulltext/370012, https://echa.europa.eu/hot-topics/tattoo-inks, https://www.env-health.org/chemicals-in-tattoo-inks-permanent-make-up-eu-wide-restriction-covering-over-4000-substances-enters-into-force-today/). Furthermore, Brexit has created another schism in the UK market, with its own regulation underway (https://consultations.hse.gov.uk/crd-reach/restriction-proposals-002/).
The new regulations have created a climate of uncertainty (https://news.cision.com/must/r/the-european-tattoo-industry-in-legal-limbo,c3475877, https://www.euronews.com/culture/2022/01/05/how-the-new-eu-ink-ban-may-be-permanently-scarring-the-tattoo-industry) that could be of good use for us, if we could provide products that stay within the required guidelines, taking up the artists that are currently unsure of how to approach this new legal framework.
Biosafety and health
All the differences in formulation create multiple risks for the final client (the tattooee) on a medical level, some of which they might be unaware of. These include but are not limited to irritation, granulomas (https://authoritytattoo.com/granulomas-and-tattoos/, https://www.aafp.org/pubs/afp/issues/2012/1001/p669.html), or possibly more severe issues (https://www.sciencedirect.com/science/article/pii/S1877782119301651, https://journals.lww.com/epidem/abstract/2020/05000/cosmetic_tattooing_and_early_onset_basal_cell.20.aspx). It could also include complications with MRI procedures (https://www.ajronline.org/doi/full/10.2214/AJR.06.5082, https://www.smithsonianmag.com/smart-news/some-tattoo-inks-can-burn-you-during-mri-180949995/), even in non-ferrous inks.
Beyond that, some of the components of classic tattoo inks could create further issues both at the medical level (https://www.sciencedirect.com/science/article/pii/S2772416623001614) and from a ecological standpoint (https://www.scientificamerican.com/article/tattoo-ink-mercury-and-other-toxins/)
Uses
Many potential uses could be taken into consideration after the initial design stages. Some of which could even cover therapeutic uses. The intersection of therapy and tattooing is not new, with plenty of pre-existing research (https://www.drugdiscoverynews.com/tattoo-therapeutics-deliver-medicine-more-than-skin-deep-15525), as well as the possibility of including biosensors (https://pubs.acs.org/doi/10.1021/acsnano.0c05723)
TECHNOLOGICAL ELEMENTS/ISSUES
PROBLEMS AND OBJECTIVES
What industry will this new venture be in, and what problem will this new company try to solve?
Biotechnology. The problem to tackle is reducing the cost and increasing the safety of biologically sourced colorants.
The objective of the company is to develop the know-how to produce colorant compounds from biological sources and outsource the scale-up and purification processes. Once the purified product is obtained, the formulation could be handled in-house or further outsourced if necessary.
Despite the practice of tattoo artistry being more or less regulated in different areas of the world (although not at the federal level in the US); currently, the regulation surrounding tattoo ink composition heavily varies depending on the area of the world.
The new regulations have created a climate of uncertainty (https://news.cision.com/must/r/the-european-tattoo-industry-in-legal-limbo,c3475877, https://www.euronews.com/culture/2022/01/05/how-the-new-eu-ink-ban-may-be-permanently-scarring-the-tattoo-industry) that could be of good use for us, if we could provide products that stay within the required guidelines, taking up the artists that are currently unsure of how to approach this new legal framework.
People to address it to:
Regulators (Safety, regulations)
Companies (Method efficiency, reduced risk, profits)
Researchers (Training, technology development)
Users (Better alternatives, novel)
Purpose: What is done now and what changes are you proposing?
Design: What is needed to make it “work”? (including the actor(s) involved - who must opt-in, fund, approve, or implement, etc)
Assumptions: What could you have wrong (incorrect assumptions, uncertainties)?
Risks of Failure & “Success”: How might this fail, including any unintended consequences of the “success” of your proposed actions?
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The objective is to create a cheaper, healthier and more sustainable alternative to current tattoo dyes using synthetic biology. To the best of our knowledge, we would be the 1st company to be involved in this particular type of production. And there is always the chance that our findings could be used in other settings as well, such as cosmetics, hair dyes, or even medical ones.
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Ensuring health & biosafety
Ensuring safe production
Efficiency

