Team:Lethbridge/Human Practices
Integrated Human Practices
Inspiration
We were initially inspired to pursue this project by the abundance of recent news articles that examine the inflated price of insulin in the USA, the migration of American patients to neighbouring countries for treatment, and the increasing prevalence of diabetes in North America. Early in the conception of this project, interviews with patients, researchers, and medical practitioners confirmed that more affordable, accessible, and needle-free insulin alternatives are highly desirable.
The Patient Perspective
We first discussed our proposed project with diabetes patients in our community and gained information about how they navigate their treatments, deal with daily injections, and the costs related to diabetes management. We learned that daily injections are painful and insulin is often unaffordable (even to those with insurance), which sometimes forces patients to choose between life-saving medication or other basic necessities.
So, at the onset of our project, our primary goal was to develop a cost-effective insulin with a painless method of administration to improve patient quality of life. Please see our Patient page for more information.
Alberta Health Services Survey
Additionally, in order to have continuous feedback from patients regarding diabetes care in Canada, we started a process to initiate a survey through Alberta Health Services. Because surveying people in Canada falls under a human researching capacity, we ensured that we would get ethical approval before distributing the survey.
In Canada, the process of getting ethical approval for a survey can be time consuming, but is necessary for the safety and privacy of those surveyed, as well as for respecting their needs and to ask questions most appropriate to the subject. It is also an excellent way to peer-review the questions to ensure the survey's success.
The process we have taken is as follows:
1. Write survey.
2. Crowd test with non-expert individuals to ensure readability and understandability.
3. Contact ethics officer with the following information: - Informed consent letter.
- Letter of intent.
- Survey.
- Distribution plan*
4. Apply to survey distributor (in our case: AHS)
5. Make revisions
6. Distribute
7. Collect Data
*Note that the distribution plan cannot be released until approved
We hope that our survey will help us to receive feedback on Algulin as we continue to develop it for the needs of diabetics.
The Public Health Perspective
Besides the economical issues surrounding diabetes treatment in the USA, we also wanted to consider insulin accessibility on a global scale. So we interviewed a medical anthropologist at the University of Lethbridge about his experience with diabetes management in Indonesia and the unique problems that diabetics face in regions of poverty. One issue that stood out to us is the inability to store insulin in regions where electricity is scarce. Thus, we factored in testing of various storage protocols to both improve shelf life and to enable distribution in third world regions.
Please see our Medical Professionals pagefor more information.
The Medical Professional Perspective
In order to understand diabetes mellitus from a clinical perspective, we discussed our project with medical doctors that specialize in the field of endocrinology. We learned that diabetes treatment regimens are very complicated and unique to each case. As such, we decided to design our project to be as versatile as injectable insulin to fit the needs of individual diabetic patients and their doctor-prescribed regimens. This included making considerations for manufacturing methods that are less expensive so that patients do not have to choose between basic necessities and life-saving drugs.
Furthermore, when talking to a healthcare aide, we learned they cannot directly help with injections and preparing insulin for injections. They can, however, assist with oral medication. We felt that providing an oral alternative would allow insulin to be better maintained, easing administration for those who require a health care aide such as children with diabetes.
Based largely on our previous interviews with a medical anthropologist, we conceptualized a prototype photobioreactor that would enable pharmacy-based production and distribution to ensure insulin access in rural or low-income communities. After discussing this possible mode of distribution with a pharmacist, it seemed plausible that small-scale algae-based production of insulin could be accomplished in a pharmacy as long as (1) the insulin was accurately measurable and (2) that algae could be dehydrated into a distributable powder. Thus, we fused a fluorescent protein to our insulin and proinsulin designs to enable ratiometric quantification of the active ingredient within the algae without the need for purification by the pharmacist. In addition, we are developing protocols to dry the algae (while simultaneously preserving the integrity of the microalgae cell wall and insulin content), which should also serve to improve shelf life over injectable insulins. Please see our Medical Professionals pagefor more information.
The Manufacturing Perspective
Market researchconfirmed that progress in the development of oral insulins has been impaired by loss of efficacy in the stomach and a lack of cost-effective manufacturing methods. While others have demonstrated the potential for the production and bioencapsulation of oral pharmaceuticals within plant chloroplasts, the bulk production of plant material is relatively time and resource-consuming (Bohyan & Daniell, 2011). Thus, we decided to prepare insulin within microalgal cells, which similarly have chloroplasts but can be grown much more cost-effectively and efficiently.
To better understand manufacturing in algae, we discussed algae growth and genetic engineering principles with a professor at the University of Northern British Columbia in Canada. We originally intended to work exclusively with Chlamydomonas reinhardtii, a model species of microalgae, but were introduced instead to Cyanidioschyzon merolae, which is an edible, acidophilic, and thermophilic strain of microalgae. Our own acid degradation testsconfirmed that the cell walls of this organism were far more resistant to the denaturing and degrading conditions of the stomach than those of other microalgae species.
We also had the opportunity to discuss our project with a startup manager who has experience manufacturing products in algae. When we informed him of our desire to use C. merolae, he confirmed that it solved many of the manufacturing challenges in algae because growing at higher temperatures and an acidic pH drastically limits the ability for contaminating microbes to grow.
Based on these discussions and the results of our acid degradation testing, we decided to integrate our insulin and proinsulin constructsinto C. merolae instead of the more common C. reinhardtii model or the health product, Spirulina. Please see our Manufacturing pagefor more information.
References
Boyhan, D., & Daniell, H. (2011). Low-cost production of proinsulin in tobacco and lettuce chloroplasts for injectable or oral delivery of functional insulin and C-peptide. Plant Biotechnol J, 9(5), 585-598.