Loomio
Mon 25 Sep 2023 5:00PM

Open Source Fermentation Process for Steroid Hormones - iGEM Vienna Collaboration Proposal

TA Thomas Alexander Public Seen by 72

Hey BwoB Community!

My name is Thomas Alexander, an Austrian-American Master's student studying Biotech Engineering in Vienna.

I had a recent conversation with Danny after I posted in the Friendzymes discord that our 2023 iGEM project is looking for global collaborators to host our project after Oct 2023.

What is our story?

While exploring opportunities in yeast bio-manufacturing, we discovered that native yeast sterols (ergosterol) can be converted to animal sterols (cholesterol) without affecting the viability of the yeast cell walls.

We further discovered that yeast are capable of modifying those sterols into steroid/sex hormones, an incredibly important class of drugs containing Pregnalone, Progesterone, Testosterone, and Estrogens.

These drugs have tremendous impact on the quality of life of a variety of patient groups: (Hypogonadic/Low T/Aging Men, Menopausal women, Patients managing Diabetes/Obesity/HIV/Other chronic illnesses, and those seeking gender affirming care)

Testosterone, our case study molecule, is a generic drug however and is currently experiencing shortages as combinations of increasing demand and the decreased profitability of generic drugs for Big Pharma.

What is our Project?

As several of the major patents on this process have recently lapsed, we would like to step in an produce an open-source protocol for fermentation of steroids in yeast, that would allow those that rely on these hormones to own the means of production.

Basing our efforts on the combination research/advocacy efforts of the OpenInsulin Foundation, our project is currently dubbed "Horm-OWN"

What can BwoB do? What can we do for BwoB?

We would like to partner with BwoB to start the conversation around this opportunity on a global scale. We see this research as a new tool to improve access to this important (and contentious) class of drugs, and do not claim to fully know how various global stakeholders could make use of it.

So much needs to be done to determine the potential impact, implications, and immobilizers of this project, but there are opportunities implicit in the inquiry itself.

Steroid hormones are a major issue that drives attention and providing an outlet for inquisitive and highly incentivized biohackers to move the needle on this issue could drive interest in BwoB and serve as harm reduction for those who may seek to copy our research for personal experimentation.

Discussion, Next Steps, and a **Point of Caution.

So what does the community do now?

  • We would like to hear from you about your perspective on the vision of this project, it's feasibility, the potential for partnerships, and/or just the overall vibe of the project.

  • How do you think this project fits in with the current plans for the BwoB community?

  • Would you be interested in contributing

    • to the research (wetlab, drylab, modeling, etc.)

    • or the protocol (patent analysis, supply chain analysis, open sourcing details, etc.)

    • or the infrastructure (fundraising, media, financial hosting details, etc.)

**Point of Caution: It should be highlighted that Testosterone, or current case study, is a Category III controlled substance in the US and therefore special precautions may need to be taken when working with this research. If you have any insight into what they are, please share your knowledge in the discussion below!

EJ

Ellen Jorgensen Wed 27 Sep 2023 2:59AM

While this is an interesting project from a scientific perspective, we do not engage in human experimentation at BwoB and attempting to manufacture a controlled drug at our facility would probably negatively impact our nonprofit lab. This project is better suited for a university or company that has all the necessary permits and safeguards to handle steroid manufacture. Having been a mentor and judge for over 12 years at iGEM, I am particularly disturbed by the idea of people trying to replicate your process in order to self-treat.

The Open Insulin project as far as I know was to develop a less expensive and IP-free method for a generic manufacture of insulin in a traditional space with all the associated quality control. Not a tool for distributed manufacture by biohackers.

I personally cannot contribute anything to the other aspects of the project (human practices etc) but perhaps other community members would be interested.

TA

Thomas Alexander Wed 27 Sep 2023 12:50PM

@Ellen Jorgensen

Hey Ellen, thanks for commenting!

To address the concerns raised in your comment, I would like to start by saying we in no way encourage the replication of our research by biohackers.

Quite the opposite. Concerned by the potential to abuse our research we wish to provide those who may seek to replicate this research a safer and more productive alternative.

That is why we included the reference to the Open Insulin project. We also aim to provide a protocol for the generic manufacture of steroid hormones in a less expensive and IP-free way. The actual manufacture must be performed in a CMO facility with all the proper safety precautions.

We understand the limitations to performing this research in your lab, but this is not the only potential collaboration possible on this project. (Access to lab space is actually quite affordable in Vienna)

What we are seeking is a non-profit partner that could help us to organize around this research, build bridges, fund raise, and begin the process of finding ways for activists, researchers, and professional volunteers to create a process that could interface with manufacturing capacity and the pharmaceutical regulatory landscape.

That is the niche that I thought BwoB could fill, one in which your infrastructure facilitates conversations around the research, rather than the potentially risky research itself.

EJ

Ellen Jorgensen Wed 27 Sep 2023 1:07PM

Hi Thomas, that's good to hear. We could certainly have an event in our space that promoted a conversation around this. For fundraising I would direct you to Experiment.com. We are in the midst of our own fundraising campaign for the lab, so I don't think we have the capacity to help you with yours. Let's see if any of the other members weigh in on this. I am at capacity and probably will be running an iGEM team out of our lab next year as well.Ellen D. Jorgensen, Ph.D.Biotech Without Borders
43-01 21st St. Suite 319
Queens NY 11101
www.biotechwithoutborders.org ( http://www.biotechwithoutborders.org )
646-942-7271

D

Danny Mon 2 Oct 2023 8:08PM

@Ibrahim Dulijan or @Patrik D'haeseleer do you have any insight into how Open Insulin started at Counter Culture, specifically whats sort of structure they first adopted? It would also be helpful to know if any of the contributors around business development are still active and if they would be interested in working on this project.

TA

Thomas Alexander Mon 16 Oct 2023 12:23PM

@Ellen Jorgensen and @Danny

I will get around to making a full proposal and community post about this idea in a while, but I was thinking about a way to get around the controlled substance aspects of this research.

Essentially, of all of the molecules that could be the product of this bio synthetic pathway research, only Testosterone is controlled. Basic research could be done on analogous pathways such as Hydrocortisone, replicating some papers in this space and testing hypothesis that might be relevant in the synthesis of Sex Hormones. It shares several of the same enzymes and It is also a extremely important drug currently under shortage in its own right. The only issue being that GC-MS and other Lipid quantification techniques may be slightly difficult for a community lab depending on your equipment and expertise.

Obviously, this is only an idea and you are in no way obligated to take interest in this research, but if you were interested in adopting open source steroid hormone fermentation as an area of research for your lab this would be a potential option. I only share it to highlight the potential of the topic to attract interested contributors to your lab.

(As for pursuing other sex hormones., I don't know how regulations would affect Estradiol, since Testosterone is part of its bio synthetic pathway.)