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Saturday, December 02, 2023

When You Have to Succeed

 Ginkgo Bioworks will help you succeed. They have a stake in your success. So much so that you will have to pay them in perpetuity if you get a drug approved. Not so much if you hire a staff of scientists to be your R&D.

I was somewhat to surprised to see a drug that came from a biotechnology company I worked for, being advertised during a streaming sports event. I did not know what they named the drug but I could tell they were selling the narrative my former employers had developed from day one. I looked it up and there it was. The one and only drug ever approved from an employer of mine in my 13 years in biotechnology.

The technology was standard stuff. Make an antibody against a target protein. Sort through the B-cells and make a list. Test the antibodies on the list, pick one, viola.

After our first project failed to get past a milestone with a big pharma partner we were in trouble. We had to move on to the next drug in the pipeline fast. We revived an abandoned project... long story short... I saw the drug on a commercial while watching UFC fights.

What happened to the guy who cloned the antibodies and sorted through them? He has been out of the business for many years. I haven't talked to him but I see from LinkedIn a curious lack of progress in his career. 

What would the difference have been had Ginkgo Bioworks done the work of finding the antibody that became the drug? Firstly there would be a considerable ongoing cost. My co-worker has long since cost anyone in biopharma a dime. Secondly, Ginkgo would have had to learn a new skill. The system of cloning and manufacturing came from a specialized yeast system. So specialized was this system, it had not been done before. The standard CHO cell system was, in the narrative of the company, subpar. They had a better system. Yeast! They had the same expression and yield results. The truth was that they expressed about 1/10th the antibodies of the standard CHO cell system and the yeast extract needed created a nightmare for downstream process development. 

The problems that came with using yeast cells were not insurmountable. They had to be handled however by far superior minds at contract manufacturing organizations (CMO's). The antibody selection was simple. The laboratory work was complicated. The manufacturing issues became simple to complicated thanks to the experience of the CMO options. 

Ginkgo Bioworks did not exist at the time my former employer could have considered them as a partner. We went with a company that had many decades of experience developing manufacturing methods that resulted in drugs that could be sold. 

Ginkgo is attempting to be your laboratory professionals. Sit in your cubicle/office and make decisions based on your needs for success. Like Donald Trump, who worked as a biotech CEO in developing the Covid vaccine, you lay out the plan. Vaccine, now, go! But the people who work in the labs have to actually produce something. It could be Ginkgo or it could be the people you hire and dress in white lab coats. Either way, you tell them your narrative and they provide you with the data you need or they go away. Even when they have succeeded, they go away. 

The difference with Ginkgo Bioworks? You have to keep paying them as long as the drug makes money. My ex co-worker and all of the people who developed the drug advertised on the UFC stream... gone. 


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