top student at medical school
Chapter 826 Generic Drug Samples
Fang Ziye understood Mei Bin's meaning, and after thinking for a while, he cautiously replied, "Professor Mei, I only intend to do full-time research on this project. You may not be suitable for it."
Generally speaking, there is an established rule in clinical practice.
Diseases that have a rapid onset are also quick to treat.
Diseases with a slow onset, even with treatment options available, take very little time to take effect, and may even be untreatable.
For diseases like peripheral neurodegenerative disorders, in-depth research and development is a long process that requires a significant investment of time and effort.
Mei Bin is a good scientific researcher, but he is also a clinical worker. Mei Bin cannot possibly have that much time to wait for me, so he is not suitable.
This collaboration between the two was actually a coincidence. Fang Ziye needed the necessary personnel, and Dean Wang Xinghuan and others directly called people over to help.
Mei Bin said with a hint of regret, "It seems Professor Fang is planning to work on an even bigger project!"
"If that's the case, then I really don't have that kind of luck."
Mei Bin could not possibly give up her professional expertise and go from being a clinician to becoming a small research assistant in Fang Ziye's professional group.
"Professor Mei, I hope there will be opportunities to cooperate in the future," Fang Ziye said politely.
Professor Mei Bin from the Department of Neurology is, to be fair, one of the team members with the most rigorous research attitude.
Fang Ziye didn't look down on the other party's abilities, but rather determined that the other party was simply not suitable for the subsequent research projects, which is why he didn't intend to cooperate.
"Okay, Professor Fang, if you remember me after you've eaten and drunk your fill, I'll be so lucky." Mei Bin's tone was slightly ingratiating.
Regardless of the rumors circulating in the hospital, he had personally witnessed Fang Ziye's terrifying nature.
Fang Ziye has brought to the forefront a spinal cord injury that is largely unknown to the world.
Unlike Fang Ziye's previous clinical studies, spinal cord injury truly started from scratch.
For example, limb salvage surgery for catastrophic injuries. Limb salvage surgery for catastrophic injuries is actually an optimized version of debridement. However, the debridement technique developed by Fang Ziye for catastrophic injuries is more meticulous and incorporates existing theories from hand surgery, such as vascular reconstruction.
For example, functional reconstruction and functional rehabilitation techniques are all modifications and optimizations of existing surgical procedures.
Even the later minimally invasive chemotherapy regimens for bone tumors were merely innovations on traditional treatment methods.
This innovation is very meaningful; for patients, it's like rain after a long drought.
However, in terms of the development of medicine, it is merely icing on the cake, far less meaningful than providing timely help in times of need.
"Professor Fang, this is for you." Mei Bin gave a thumbs up, her tone full of sincerity and earnestness.
"Thank you for the compliment, Professor Mei. I see that the project on optimizing the functions here is progressing quite smoothly, so I'll be leaving now."
“There are people waiting for me next door…” Fang Ziye said.
“Okay, Professor Fang, you can go ahead with your work…” Mei Bin stood up to see him off.
Mei Bin also knew that Fang Ziye was not only the main person in charge of the spinal cord injury research project, but also had other research projects running in parallel, but she did not know the details.
As a scientific researcher, it is a basic professional ethic not to pry into other people's research secrets, so no matter how curious he was, he did not ask any further questions.
Fang Ziye had just stepped out of the animal laboratory when he saw a message from Hu Qingyuan: "Master, I'm not going to the sanatorium with you today. I made an appointment with Brother Song Yi to go into the laboratory together."
Everyone knows that Hu Qingyuan is Fang Ziye's beloved disciple. Fang Ziye takes Hu Qingyuan with him wherever he goes, even though Hu Qingyuan's basic skills are not very good.
Compared to other PhDs like Feng Junfeng, Fang Ziye showed a much stronger preference for Hu Qingyuan.
“Okay…you guys have fun.” Fang Ziye said.
Fang Ziye couldn't think of a good way to fill the hole left by Song Yi for the time being. He could only wait for Song Yi and Hu Qingyuan to come up with something and explain it to him before fixing the 'ideas' and 'skills' on the panel.
Then, by allocating points to improve individual skills, you can move forward.
This pattern is the existing rule for newly developed techniques!
You can't create something from nothing, but you can increase it from a small amount to a large amount by adding points.
In the basic laboratory, Dong Ning was having a discussion with Wang Wei, Dai Gongchu, and a few others.
Dong Ning said, "Compared to the original drug, the effective content of the drugs produced by our current production process is still somewhat lower, at only 75%."
"In the same amount of the original drug, the content of the active ingredient is on average more than 95%."
The so-called effective content refers to the actual content of a certain drug substance as stated in its instructions.
Generally speaking, the higher the effective content, the better the therapeutic effect.
Of course, it can't be too high either; if it's too high, then it might be a different kind of medication.
"Professor Dong, the Professor Fang you're following is simply a genius. How is he able to deduce so many specific and minute details just by looking at the manufacturing process of medicine?"
"Temperature, humidity, duration—how could you possibly guess those?" Dai Gongchu, standing beside Dong Ning, spoke with utter astonishment.
Dong Ning chuckled and said, "So he's Professor Fang, and I'm just a little doctor named Dong Ning."
"If I knew how Professor Fang could do such a thing, you should all call me Professor Dong."
"How about I call Fang Ziye over and give you a detailed report and explanation, Engineer Dai?" Dong Ning joked in his announcer's voice after being busy for a long time.
Dong Ning has a very pleasant voice, which makes it easy for her to connect with people.
Even when she's joking, it sounds like a gentle breeze.
Dai Gongchu hurriedly shook his head, but before he could speak, Fang Ziye strode in: "Teacher Dong, Brother Dai, Engineer Wang, I'm here..."
Dai Gongchu and Wang Wei are both engineers at Guangbai Group responsible for basic pharmaceutical research and development. I heard that they hold high positions within the company and were specially sent by Yao Guang to help out.
Fang Ziye received a research project from the National Natural Science Foundation of China, but the project will not only be the responsibility of Fang Ziye personally; the Zhongnan Hospital of Wuhan University and the sanatorium where Fang Ziye works will also bear the "responsibility"!
Moreover, such projects will certainly be staffed with other personnel, including but not limited to relevant talents in pharmaceutics.
Of course, pharmaceutical professionals haven't arrived yet, and Fang Ziye and Dong Ning are only in the early stages of exploring generic drugs.
"Professor Fang!"
"Professor Fang..."
“Professor Fang… I was just joking.” Dong Ning was the first to stand up, and the last to speak, explaining softly.
He directly named Fang Ziye, which was really just a joke.
Even if Fang Ziye isn't particularly outstanding, being an associate professor at a teaching hospital gives him a higher social status than an engineer in a company.
Fang Ziye, of course, wouldn't delve into such details, and asked, "Brother Dong Ning, I just heard you say that since the last optimization, the effective ingredient content of this batch of generic drugs has increased to 75%, right?"
Dong Ning nodded in agreement: "Yes, Professor Fang!"
"You're amazing. My initial plan only had less than 30% effective ingredients. It's all thanks to you." Dong Ning smiled with a hint of worldliness.
Dong Ning originally planned to show off in front of Fang Ziye and let him see her true abilities.
Dong Ning did indeed do that, but it seemed that Fang Ziye didn't give much feedback. Instead, after receiving the results of the first batch of samples, he started giving instructions non-stop.
Dong Ning was certain that Fang Ziye wasn't bluffing; he genuinely didn't take the 30% initial trial seriously. Fang Ziye might not even have known the significance of that figure.
The development of a drug, even a generic one, requires an investment of tens of millions of dollars.
How did all that money go down the drain? Through repeated failures, repeated tolerance for mistakes, and massive investments of time and resources…
It's already pretty impressive that the first batch of drugs contains 30% effective ingredients and can be purified and packaged into a marketable form.
However, Fang Ziye's disregard was not without its reasons.
“Although imported and domestic vancomycin have the same main ingredients, some excipients are added during the drug manufacturing process, and there are certain differences in the excipients added between imported and domestic drugs,” Fang Ziye said.
"These added ingredients are hard to figure out."
"Of course, vancomycin is also a commonly used intraoperative drug in our orthopedics department, and it is widely used whether it is injected intravenously or applied topically."
“Currently, domestically produced vancomycin is usable. However, its efficacy is difficult to assess.” Fang Ziye was looking at the data extracted by Dong Ning and others.
Although Fang Ziye wants to develop generic drugs, he certainly can't just choose any drug to copy; that would be a joke. Fang Ziye is an orthopedic specialist, so naturally he prioritizes drugs that are commonly used in orthopedics and have a certain clinical demand as his initial targets.
In orthopedics, postoperative joint infections are particularly troublesome in joint surgery, making the intraoperative use of vancomycin necessary.
The current clinical situation is that we need to use it, and we are using it, but the infection rate is not as easy to control as before.
Because it's a centralized procurement, reporting a slight increase in the infection rate of patients encountered by individuals is useless.
Because it's cheap, that's the only way you can use it. If you get infected, then you can get treatment. At least that's the general direction...
If an infection occurs during postoperative hospitalization, the department will cover it up on its own!
Current joint replacement surgery is a one-time, pay-as-you-go system, regardless of whether complications occur.
Dong Ning said, "Vancomycin is a glycopeptide antibiotic, mainly used to treat serious infections caused by Gram-positive bacteria such as methicillin-resistant Staphylococcus aureus."
"Currently, the main preparation process relies on microbial fermentation and subsequent separation and purification, which is a typical biopharmaceutical process."
"Vancomycin is produced by *Amycosis orientalis* or similar actinomycetes. We have a good grasp of the concentrations of culture medium, ammonia source, inorganic salts, and precursor substances."
"However, in terms of strain improvement, we can optimize it in more detail: through mutagenesis breeding or genetic engineering, we can screen for high-yield strains (such as improving drug resistance and optimizing metabolic pathways)."
Fang Ziye looked at it and nodded: "Actually, the fermentation conditions can be controlled in detail. I personally think that dissolved oxygen and fermentation cycle are also key factors affecting the final yield."
“Quantity and finished product are two different things. Separation and purification processes are what we need to focus on developing.”
"Currently, through mass spectrometry analysis, we can confirm that the active ingredient is the structural formula of vancomycin."
"However, we can optimize the separation and coupling step of the fermentation broth..."
"This is a major challenge in the preparation of biological drugs, not purely chemically synthesized drugs."
“You can consult more professional people about these things. I only know the purification steps, how to optimize the purification structure, and whether there is mature equipment, etc. I can't give better advice.”
“After all, I’m a medical professional,” Fang Ziye said.
Using medicine and making medicine are completely different.
When Fang Ziye uses medicine, he doesn't care how it's prepared; all he cares about is its efficacy, and that's all he needs to do.
In addition to production efficiency, pharmaceutical manufacturing also requires attention to the manufacturing process. Differences in every detail can lead to more impurities in the final product.
Or, during the purification process, impurities may be mistakenly added to the drug as active ingredients, resulting in insufficient efficacy.
Dong Ning nodded and said, "Professor Fang, the amount of guidance you provided in the biological experiments section has already made our progress very fast."
"The rest, of course, we'll figure out a solution ourselves."
"We're not experts in anything related to equipment either."
"Professor Fang, we conducted a concentration titration test on these samples today, and the results showed that there were still quite a few impurities."
"In other words, when we performed chromatography, we did not find the ligands of the specific antibody. The ones currently on the market are probably not good products."
"I suspect that the original drug company never intended to release the formula for this ligand."
"If we can achieve a breakthrough in affinity chromatography, our purification purity can reach at least 95%!" Dong Ning said.
Antibodies and ligands are somewhat related to medicine.
"Okay, I'll go look up the relevant information too."
"Teacher Dong, thank you for your hard work in finding so much information and details." Fang Ziye appreciated Dong Ning's ambition.
He doesn't just dump problems on you; he dumps problems that need to be solved on you, and his words are meaningful.
It's like a student directly asking the teacher how to do this problem, instead of directly asking how to improve their grades.
Focusing on specifics and addressing the difficulties that Fang Ziye might encounter in a particular step, we seek advice on Fang Ziye-related issues!
"I'll think about finding specific antibody ligands first, and I'll give you an answer later."
“Anyway, you also have a mature team for basic scientific research…” Fang Ziye said.
"Professor Fang, there's no rush. We still need to put in some more effort in the early stages of strain improvement."
“This kind of drug, which is not manufactured using chemical methods, requires the most skill and expertise,” Dong Ning said, eager to try.
Fang Ziye said, "By the way, Brother Dai, did you find the instructions for this medicine for all countries that I asked you to find before?"
"I want to collect them all to see if there are any translation errors or inaccuracies."
"Also, vancomycin is produced in the United States. You should also search some non-statistical source journals in the United States to see if there is any other useful information about vancomycin."
"It is possible that other copying companies in their own country may obtain copying licenses and apply for new patents by publishing papers during the copying process."
"This is all information we can use..."
"Of course, we can also buy some of the generic versions produced in other countries. We'll see if we can find some other shortcuts among different generic drugs."
"..."
Fang Ziye also meticulously assigned tasks to Dong Ning and the others, clearly stating exactly what they were to do!
The reason these preliminary preparations weren't done at the beginning was to let Dong Ning and the others tinker with things on their own for a while, so they could figure out where their weaknesses lay.
Only after doing this can they selectively extract the relevant information.
Knowing your own limitations is self-knowledge; knowing others' strengths is enemy-knowledge!
Developing generic drugs is not like waging war, but knowing yourself and your enemy can save a lot of time and money.
"Okay, Professor Fang."
“We’ve noted down all these details. Is there any other guidance? I’ve found that even after several days or a month of discussion, it’s not as effective as a single word of guidance from Professor Fang,” Dai Gongchu said, slightly ingratiatingly.
Fang Ziye seemed to have a cheat code, listing many objective conditions that could make their preparation more efficient.
"That's all for now. I think this should be enough."
"If our fermentation and purification processes can be optimized, then the yield and cost can be further reduced, and the efficacy can be guaranteed."
"That's where the real value comes from."
"Vancomycin's market share worldwide is not high, less than a billion US dollars, or a little more."
"We'll take whatever we can get," Fang Ziye said.
Just as Fang Ziye said this, the phone rang.
Dong Ning and the others were not surprised.
Fang Ziye's current status is quite extraordinary; he is no longer an unknown little doctor who is only bothered by his superiors and family members.
Many students now seek Fang Ziye's medical advice or even ask him to be their mentor. They have all obtained Fang Ziye's contact information through their own networks.
“Tianluo!” Fang Ziye asked.
"Senior brother, that patient who was discharged on the 23rd is causing trouble again." Lan Tianluo's tone was annoyed.
"Senior, what should we do this time? Should we call the police directly?"
Upon hearing this, Fang Ziye frowned slightly, turned around and walked a few steps away from Dong Ning and the others: "Let's handle it the same way as before. If it can be resolved within the department, then resolve it within the department. If it really can't, then resolve it through the judiciary."
"Or, you could ask him directly what his demands are, and what he wants the hospital to do with my case?"
"Stop seeing patients? Fine, you can stop seeing patients, but you can also revoke my surgical privileges. Let him report me to the medical affairs department all he wants?"
"If we're going to sue, then we'll sue... We can't back down." Fang Ziye's stance was very clear. (End of Chapter)
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