Before you read on, please be aware that the analysis below is my opinion only and may include flawed assumptions and inaccuracy of logic; therefore, caveat emptor applies here. Furthermore, all emphasis (color-coded, boldness, and underlined) on the excerpts are my own.
Last week, I shared my thought on how United Therapeutics (UT) is ready to move to the next level of creating a 3D bioprinted solid-organ scaffold. Per the CEO of UT from its recent 2019 Qtr2 Conference call earning transcript, UT succeeded in expanding over a trillion healthy cells in a scaffold. If the lung organ requires only 5 to 10 billion cells, then the next step is to cellularize the 3D bioprinted lung collagen scaffold with the patient’s cell. Once complete, clinical trials begin!
However, even a layman like me knows that there are still a year or two before the 3D bioprinted solid-organ lung scaffolds are ready for clinical trials. I can visualize the need to test and retest numerous versions of the cellularized 3D bioprinted solid-organ scaffold until an optimal composition is discovered to be workable and safe for transplantation.
And to have enough rhCollagen to stockpile the bioinks for testing of the solid-organ lung scaffolds, I believe iBio has to be busy manufacturing the CollPlant’s rhCollagen for the Lung Biotechnology now.
So, what is the amount of rhCollagen Lung Biotechnology needs to begin the testing?
I don’t think we will ever find out since Lung Biotechnology has to protect its trade secrets by not divulging any information related to organ development projects. However, we can use existing public information to deduce a broad idea of the amount required.
Currently, CollPlant has a 6,000 square foot cGMP facility. Below is an excerpt from its April 2018 PR release.
“This 6,000 square foot cGMP facility was designed for purification of rhCollagen and formulation of end-products, including BioInks for 3D bioprinting and its proprietary tissue repair products. The facility includes clean rooms, logistic support areas, and dedicated production equipment to support the company’s production demand for the next few years.”
My opinion is that if the 6,000 square foot facility is not large enough to satisfy the Lung Biotechnology requirement of the quantity needed, then it made perfect sense for the company to sign an MSA agreement with iBio to scale up production.
Based on the above, I can imagine that iBio will have to grow a lot of plants (each plant is a bioreactor) to extract enough collagen to fill a bottle of bioink. And how many bottles of bioink is needed to bioprint a scaffold the size of the lung? To get an idea of the size of the solid-organ lung scaffold, look at your chest. There are two lungs (left and right) behind the ribs of our body. That is a pretty large size relative to the tiny scaffolds used by research organizations & academic institutes, and biopharmaceutical companies for experimenting and testing. Furthermore, to run tests to find an optimal setup for a “breathable lung,” I can see the need to work with a lot of lung scaffolds. Multiply the number of lung scaffolds by the number of required bioinks for each lung scaffold, and you are talking about a LOT of bioinks.
Given the massive size of the scaffold relatively speaking, I believe iBio has the PERFECT facility with the necessary CAPACITY and SPEED to manufacture the rhCollagen required by Lung Biotechnology for testing. The following article, “Lung Biotechnology tags iBio for bioink production,” further confirmed the inevitable scale up production of rhCollagen.
Below is an excerpt:
“Lung Biotechnology, a public benefit corporation subsidiary of United Therapeutics, will use the scaffolds to create bioprintable lungs. iBio will use its FastPharma platform—an automated plant-based protein expression system combined with hydroponics and glycan engineering—to scale up production of CollPlant’s bioink for fabricating lung scaffolds that can then be taken to clinical trials. Additional collaborations might be needed to optimize and expand the process for producing commercial quantities, iBio said.”
Imagine competitors using the mammalian cell system to produce the collagen needed for lung scaffold; they could be YEARS behind Lung Biotechnology in getting to the clinical trials due to inefficiency and difficulty in scaling up production. There is also two major disadvantage of using mammalian cell systems- the exorbitant cost due to the size of the organ and the impurity (mentioned by CollPlant) that may cause issues during clinical trials.
It is also my opinion that once the cellularized 3D bioprinted solid-organ scaffold becomes a success story, even iBio’s large facility will NOT be enough to supply the rhCollagen needed to meet demand. Hence, the MSA agreement included the additional projects focused upon process optimization and capacity expansion. Capacity expansion will employ iBio’s Factory Solutions capabilities.
All the above is my logical deduction to support my thesis that iBio will be generating revenues from manufacturing rhCollagen for Lung Biotechnology, starting with the 4th quarter of 2019.
Lung Biotechnology PBC has an edge over other competitors!
To me, the key to the success of any company is the CEO/founder behind it. Apple had Steve Jobs. Microsoft has Bill Gates. Tesla has Elon Musk. Google has Larry Paige and Sergey Brin. Facebook has Mark Zuckerberg. United Therapeutics has Martine Rothblatt.
Martine Rothblatt’s unstoppable quest to save lives and for a better future is the driving force behind the success of United Therapeutics. From what I read, Martine built a $1.5 billion company to develop the pulmonary hypertension drug to save her daughter’s life, and those suffering the same rare disease. Now, Martine wants her company to be the leader in the emerging organ development industry to save more lives.
Below is an excerpt from the article, “Martine Rothblatt’s theory of evolution,” that best describe Martine ‘s goal:
Below is the summary of the above excerpt:
- Create an unlimited supply of transplantable organs to keep people living indefinitely
- Determined to wrestle the “engineering problem” to the ground
- Long-term play to conquer the global organ shortages is in motion
- Already restored diseased donor lungs that could traditionally have gone to waste
- NO other company that’s trying to come up with the multiprong solution that is United Therapeutic
Number 5 regarding the multiprong solution highlighted Martine’s commitment to making her vision of replaceable human organs a reality.
Below is a flow-chart from the same article that best displayed the multiprong solution:
Notice the BioMechanical solution is where the 3D bioprinted solid-organ scaffold comes into the picture.
Below is another excerpt from the article that touched on the area of 3D bioprinting of solid-organ lung scaffold.
Below is an outline recap of the above excerpt:
- A new partnership with 3D printing company 3D Systems Inc to create scaffold on 3D printers
- The printing company hooks the lungs up to a machine as they accept their new human cells to test their ability to “breathe.”
- If successful, the 3D route would be easier to scale
- much less expensive to pull off
- Great benefit of the 3D printed scaffold
- can make any size and shape that is necessary for different patients’ chest size
In my opinion, numbers 2 & 3 above highlighted the importance of the success of the bio-mechanical solution because it is more economical and more flexible in custom-design the replaceable organs to fit the patients’ body.
While it may take a few more years for Lung Biotechnology to come up with a final workable cellularized 3D solid-organ scaffold lungs for transplantation, I can see iBio as an essential part of the testing process starting now. Lung Biotechnology’s success story on 3D organ transplantation can transform organ development into a multi-billion dollar industry. And this may carry iBio into the billion-dollar market cap as well. Meanwhile, do you think that iBio will remain a paltry $13 million market cap company while being one of the essential components of Martine’s goal of making replaceable human organs a reality?
Elon Musk broke the barrier to the electric vehicle, and I can see Martine Rothblatt breaking the barrier to create replaceable organs for the mass. My opinion is that Martine Rothblatt has the drive, ambition, and resources to make it happen.
Here is quote from the article, “Martine Rothblatt: She founded SiriusXM, a religion and a biotech. For starters” that I found to bring an optimistic view to Martine’s quest.
“She has to my knowledge a perfect track record in making [her] visions real,” Kurzweil writes in an e-mail.
To put the above quote in context, when Martine Rothblatt learned about satellite technology, she had an idea and found Sirius XM (worldwide satellite radio.) When she found out her daughter has pulmonary arterial hypertension, a rare disease that the BPs didn’t want to bother with, she found United Therapeutics and developed the drugs to help her daughter to live a full life. Martine is now seeing a future where human organs can be replaced just like an old car can replace defective parts.
In other words, Lung Biotechnology PBC, under the guidance of Martine Rothblatt, has an excellent chance to be the trailblazer in the field of transplantable organs. And iBio has the honor to be invited to take a ride with Martine Rothblatt’s quest.
The future is BRIGHT for $IBIO as far as I”m concerned.
My 2 cents