In the presence of Hadassah CEO Prof. Zeev Rothstein, Chairman of S.R.I., Avi Balashnikov, heads of the Israeli healthcare system, and representatives of the Israeli Association for Nuclear Medicine, the new production rooms of S.R.I. (Specialized Medical Services) were inaugurated on the Hadassah Ein Kerem campus.

S.R.I. is a subsidiary of Hadassah Ein Kerem Hospital. The company specializes in the production and development of radiopharmaceutical products and is the only one in the country that has clean rooms and cyclotron facilities (particle accelerator) that includes eight automatic modules for synthesizing particles of various types (cyclotron products).

The construction of the new production rooms took about four years, and included clean rooms and state-of-the-art systems for the production of radiopharmaceutical products without human contact that meet the strictest standards of the Ministry of Health, as well as those of the European authorities and the American FDA, and ensure maximum patient safety.

The cost of the new production rooms is estimated at approximately 13 million NIS. S.R.I. products are supplied for PET tests to Hadassah Ein Kerem Hospital and a number of hospitals throughout the country, including: Assuta, Beilinson, Sheba, Ichilov and Shaare Zedek.

The location of the cyclotron facilities is approximately four floors underground in rooms with 2.5-meter-thick concrete walls, which is essential for maintaining environmental safety. It should be noted that S.R.I. is the only company in Israel that has two cyclotron facilities that produce simultaneously and serve as a backup in case one of the facilities is under maintenance.

CEO of SRI, Prof. Eyal Mishani, a pioneer in the cyclotron field in Israel who also serves as a senior advisor to the International Atomic Energy Agency, said that the new facility includes state-of-the-art production rooms built to the highest quality currently available in Israel, which meet the strict global standards of both European and American standards (FDA), which are the highest level of patient safety.

Prof. Zeev Rothstein praised Prof. Mishani’s activities in his remarks and noted that the issue of patient safety is one of the central and most important issues that must be emphasized today in modern medicine, and added that the new production facility will make this possible for the thousands of patients each year at Hadassah and other hospitals who need radiopharmaceutical products.

Chairman of the Board of Directors of SRI and former Chairman of Hadassah Hospitals, Avi Balashnikov, said that he welcomes the Ministry of Health’s decision recently made to promote stricter standards in the field Radio Medicines in Israel, and that he expects that in this issue, which is critical to the health of patients, there will be uncompromising enforcement against those who operate in an uncontrolled manner and according to the strictest safety conditions.

The chairman of the Nuclear Medicine Association, Dr. Zvi Bar-Saber, said at the ceremony that the state-of-the-art production rooms of the S.R.I. company are of the highest level and are an example of quality in all matters related to work procedures, improvement and quality control.

Source: Jerusalem Net: Hadassah Ein Kerem Campus: New production facility for medicines

הפוסט Hadassah Ein Kerem Campus: New Pharmaceutical Manufacturing Facility הופיע לראשונה ב-ש.ר.י.

The new production rooms in Israel for the production and development of radioactive drugs, built at the Hadassah Ein Kerem campus with an investment of 13 million shekels, were inaugurated. The ceremony was attended by Hadassah CEO Prof. Zeev Rotstein, CEO of S.R.Y. Company, Avi Blashnikov, senior officials from the Israeli healthcare system, and representatives from the Israeli Society for Nuclear Medicine.

S.R.Y. (Specialized Medical Services) is a subsidiary of Hadassah Ein Kerem Hospital, specializing in the production and development of radioactive drug products. It is the only company in the country with clean rooms and cyclotron facilities (particle accelerators), which include eight automated modules for the synthesis of various types of particles (cyclotron products). The construction of these new production rooms took about four years and included clean rooms and advanced systems for producing radioactive drug products without human contact, meeting the highest standards of the Ministry of Health, as well as European and U.S. FDA regulations, ensuring maximum patient safety.

S.R.Y.’s products are supplied for PET scans at Hadassah Ein Kerem Hospital and a number of other hospitals across the country, including Assuta, Beilinson, Sheba, Ichilov, and Shaare Zedek.

The cyclotron facilities are located about four floors underground in rooms with concrete walls 2.5 meters thick, essential for maintaining environmental safety. Notably, S.R.Y. is the only company in Israel with two cyclotron facilities operating simultaneously, serving as backups in case one facility is under maintenance.

S.R.Y. CEO Prof. Il Mishani, a pioneer in the cyclotron field in Israel and a senior advisor to the International Atomic Energy Agency, said the new facility includes the most advanced production rooms built to the highest standards currently available in the country, meeting both European and U.S. (FDA) regulations, which represent the highest level of patient safety.

Prof. Zeev Rotstein praised Prof. Mishani’s work and emphasized that patient safety is one of the central issues that should be prioritized in modern medicine. He added that the new production facility would effectively support thousands of patients each year at Hadassah and other hospitals in need of radioactive drug products.

Avi Blashnikov, Chairman of S.R.Y.’s Board of Directors and former Chairman of Hadassah Hospitals, welcomed the recent decision by the Ministry of Health to advance stricter regulations for radioactive drugs in Israel. He expressed hope that there would be uncompromising enforcement regarding those who operate without regulation and fail to meet strict safety standards.

Dr. Tzvi Bar-Sever, Chairman of the Israeli Society for Nuclear Medicine, stated that the new production rooms of S.R.Y. are of the highest level and serve as an example of quality in terms of work procedures, optimization, and quality control.

Source article: כתבת מקור: https://www.kolhair.co.il/health/14061/

הפוסט Ein Kerem Campus: New drug development rooms inaugurated הופיע לראשונה ב-ש.ר.י.

Inside a Bunker Underneath the Jerusalem Hospital Lies a Particle Accelerator, Cyclotron by Name

Dror Feuer entered the holy of holies and tried to understand how they produce such innovative radioactive materials here, which, after being injected into cancer patients, will act in the body like guided missiles on their way to locate and eliminate targets.

Special for G

The soundtrack four floors below ground, in the basement of the Nuclear Medicine Department at Hadassah Ein Kerem Hospital, is one I’ve heard during thousands of hours of watching science fiction series and movies. It’s like being on the bridge of the Starship Enterprise. The noises from the world above don’t reach here. Here, you only hear mechanical beeps and digital rings. Beep-beep, cling-cling, and of course, woo-woo and ee-ee and wrrrrrr, and above all, there’s a thin layer of continuous hissing.

Here, between 2.5-meter-thick walls with cooling and air conditioning systems isolating it from the rest of the hospital, lie two particle accelerators, cyclotrons by name. One is old, about twenty years old, and the other is newer, about seven years old. They look the same. Each one resides in its own bunker, with its own control and monitoring room, cooling, maintenance, and electronics rooms. On the way there, we pass through and I derive great pleasure from the charming contrast between the high-tech and the delightful chaos in the place. Piles of papers lie everywhere, boxes, instruments, bottles, and whatnot. A small coffee corner leads to the maintenance room full of saws, hammers, screwdrivers, and a variety of tools I didn’t expect to see in a particle accelerator. Very Israeli. The control rooms are full of clocks and measuring instruments, some of which are going forward, and some backward.

We enter the holy of holies itself. The accelerator occupies most of a small room, with thousands of pipes in all colors and diameters coming in and out, looking like the forbidden yet passionate lovechild of a spaceship and a pressure cooker. A little over 2 million dollars each. It looks a little like a living creature. I can’t decide if I expected more or less, in any case, I’m satisfied. Everywhere I touch, I’m immediately told: “Don’t touch!” and then they walk through with the radiation meter, which beeps happily. Everything’s fine, they reassure me, nothing dangerous. So every time they’re not looking, I touch.

Inside the accelerator, there is a vacuum, like in space, the result of four diffusion pumps that export a pressure of 10 to the minus 7 atmospheres. “Explain to me what’s happening here,” I ask Professor Eyal Meshani, head of the cyclotron unit. “To make a nuclear reaction,” he responds, “we take charged particles, accelerate them in an electric and magnetic field, and then bombard them with other stable materials.”

Clear. Now explain it to me slower.

“First, you create a charged particle. In our case, we take hydrogen gas, put it inside, and pass it through a high electric field. It breaks it down and creates plasma. Plasma is chaos. From it, I extract, using another electric field, another particle that, because it has mass and electric charge, starts moving in a circular motion inside the electric and magnetic field. With each rotation, it increases in speed and energy until it reaches an energy of 18 mega-electron volts, and then I shoot it out of the field into a target, where it’s bombarded with high-energy protons, creating a new element called F19. That’s the radioactivity.

“Think that inside this insane vacuum, there are no collisions, and I can focus a beam to millimeters,” Meshani continues. “The whole process is cooled with helium to minus 180 degrees. What comes out, a radioactive solution, I send through thin tubes to the lab, where I separate the radioactivity from the water and charge it onto a smart molecule.”

“It’s True for Many Diseases”

Meshani, 54, probably sees in my eyes that while my body is here, my mind is still catching up. “Let’s say you have a military hangar in Syria,” he demonstrates. “You send a plane that photographs it from above, and now you know everything about the configuration of the place, its location, the setup, the fences, etc. But you don’t know anything about what’s inside, whether it’s tanks, planes, or missiles. That’s actually anatomical imaging, like X-ray, CT, ultrasound, and also MRI. But that’s not enough, right?”

Of course not.

“The world is moving towards personalized and targeted medicine. This requires much more complex and intelligent solutions, but for that, we need information. How do we get it? There’s an invasive way—cutting, doing a biopsy, taking samples, doing pathology. It’s great, but there are problems with it—it takes time, you need to take samples from different places, and it’s painful. There’s another way to get information—molecular imaging.

“To go back to the analogy, instead of sending a plane, I send Sayeret Matkal (Israeli elite unit), who enter and report exactly what’s going on inside. That’s molecular imaging, which allows us to see elements at the cellular level. How? You inject a radioactive material, which is a smart material. A guided missile. You put the material into the blood circulation, and it’s attracted to certain elements of the tumor. These materials are what we produce here, in the accelerator. I’m essentially inserting a spy program into tissue in the human body that constantly sends me signals. The smart material knows where to go, and the radioactive isotope knows what to do there.”

In such an imaging, PET-CT, unlike anatomical imaging, you can see very precisely, for example, if there are certain lung tumors that only 20% of the patients have. Then, instead of bombarding the whole body with everything you have, you can take smart materials and load them with a radioactive isotope that you inject into the blood. “The isotope sends us signals, and we track it when it accumulates in the tumor area and then know if the element we want to bombard is there or not,” says Meshani. “And this is true for many diseases. For example, understanding processes in the brain, like in the case of Alzheimer’s, where beta-amyloid plaques accumulate there, and there are materials that can find these plaques long before the symptoms start. This is excellent for early diagnosis, even though there is still no cure, and we produce these materials here.”

If you’ve already reached the tumor, why just send signals and not blow it up?

“If there are neuroendocrine tumors (see glossary to the left), we treat them with a material that knows how to reach them and kill them. That’s the direction, but it’s important to emphasize, this doesn’t replace biopsies or other treatments.”

And in the future?

“Like everything, there will be a combination of tools. It’s one of the tools in modern medicine, to guide more effective drug treatment and to track it better. Another advantage of this imaging is that it’s much faster than CT or ultrasound. If you give a biological substance in a CT to kill a tumor, you can only see the result when the mass disappears, and that can take four months. Here you can see it immediately. But it’s complicated, complicated, expensive, and not simple.”

What about dangerous?

“We give the material in very small quantities. In general, these materials have no mass, only electric charge. So, there’s no toxicity problem. The radiation is very specific, and we know how to read it. These are very unique materials, many of them don’t live long. They have a half-life. Some live for two minutes or less. The longest half-life of our materials here is 110 minutes. Such a half-life means you can’t import it or store it—you need daily production.”

The Difference Between a Reactor and a Cyclotron

We stand before the accelerator, which is currently working at 515 milli-amps, the pressure inside it reaches 31 bars, and the protons are bombarded at 75 micro-amps. “Today, we produced 5.5 curies, which is a lot,” says Meshani. It produces radioactive materials—mostly those that contain glucose, which is consumed in high percentages in the brain, bladder, and tumors. The material is injected into the body and tracked using the imaging device until it reaches the cancer cells, allowing for diagnosis and treatment.

The cyclotron uses both an electric and magnetic field to produce nuclear materials for research and medical uses, specifically for PET imaging. It was invented in the 1930s and consists of two half-cylinders in the shape of a “D,” between which is an electric field that accelerates charged particles that pass through in a circular motion (thanks to a magnetic field).

The accelerator keeps doing its thing, but what gives me pleasure is discovering that it’s all related to radiation—nuclear medicine from the future, but in the end, it’s still connected to the trash can. In the corner of the room, two trash bins—one for regular waste and one for radioactive waste. I hope they don’t get confused. “Before opening the cyclotron,” a large sign reads, “Don’t forget to turn off the air conditioner.”

Why are we so deep underground and between such thick walls? Could this thing explode?

“No. The beauty of the cyclotron, and the difference between a nuclear reactor and a particle accelerator, is that when you turn it off, there’s nothing. In Canada, they have accelerators inside shopping malls.”

So, how does it work on a daily basis, and how do you know what to produce? Do the hospitals call and say, ‘

הפוסט Journey to the Earth’s Core: The Fortified Particle Accelerator That Fights Cancer הופיע לראשונה ב-ש.ר.י.

Today, the most common material in the world for imaging prostate cancer is 68Ga-PSMA, which led to a revolution in the field of imaging in the diagnosis of prostate cancer, with its entry into regular use in 2012.

The advantages of 68Ga-PSMA are:

Increased early diagnosis ability

Improved uptake in tumors

Low background and ability to diagnose metastases, including in small lymph nodes

However, 68Ga-PSMA has several disadvantages:

Relatively low resolution, resulting from the use of the 68Ga isotope

Significant renal clearance and accumulation in the bladder, which limits diagnostic ability

Short half-life, which limits its distribution to distant targets

Limited throughput (3-4 doses per production batch)

The use of generators forces the manufacturer to depend on a third party

As of 2017, the availability and price of generators has been a real challenge

During 2017, several studies were published in the international scientific literature that dealt with the development of an innovative marker based on PSMA and labeled with 18F, namely 18F-PSMA-1007

18F-PSMA-1007 is a marker with improved clinical and pharmacological properties compared to 68Ga-PSMA, which allows for better logistical operation and is attracting great attention among the international nuclear medicine community

The advantages of 18F-PSMA-1007 are:

Improved resolution, resulting from the use of the 18F isotope

Rapid clearance mediated by the liver (hepatobiliary clearance) and reduced absorption in the bladder

Degree of labeling High

Ideal half-life

High-throughput production capacity (high number of doses)

Independent production without dependence on a third party

Improved tumor uptake and high sensitivity, with an emphasis on disease recurrence at very low PSA levels

In light of the outstanding advantages of this material, S.R.Y. launched a regular production line for 18F-PSMA-1007 in 2017

הפוסט Launch of a new 18F-PSMA-1007 production line הופיע לראשונה ב-ש.ר.י.

For the first time in Israel: A simple, non-invasive brain mapping test will identify the chance of developing Alzheimer’s disease. The test can identify the protein associated with the risk of developing the disease and therefore may help diagnose it in advance, or in its early stages – something that has not been possible until now.

The test is mainly relevant for those who have a family history of the disease or suspect its existence, and it can help adjust treatment to prevent and slow it down.

It is recommended for people aged 45 and over, but it can be performed at any age. The test is currently provided in some Western European countries, and now, for the first time in Israel, it is being performed at Hadassah Medical Center in Jerusalem. So far, a few individual tests have already been performed.

Prof. Eyal Mishani, Head of the Research and Development Department at Hadassah Medical Center, explained: “The mapping is done by injecting a non-hazardous radioactive substance, in a brain scan with a PET CT device. It can be used to identify the amount of proteins whose presence is a sign of the development of Alzheimer’s. Understanding that there is a connection between that protein and the disease can also help develop drugs to stop Alzheimer’s.”

Dr. Dana Eckstein, Director of the Department of Neurology, emphasizes that the test is recommended after consulting with a neurologist, who, based on the test results, will be able to recommend an appropriate treatment that can delay the progression of the disease. It can be assessed whether it is dementia caused by Alzheimer’s disease or dementia due to another disease.

Source article: https://www.ynet.co.il/articles/0,7340,L-5563190,00.html

הפוסט For the first time in Israel: A test that will identify the chance of developing Alzheimer’s הופיע לראשונה ב-ש.ר.י.

A new medical test that could help doctors prevent the onset of Alzheimer’s disease – and discover new and better treatments for it – is now being conducted in Israel.

Hadassah Ein Kerem announced that it’s SRY subsidiary has contracted with General Electric (GE) to be the sole producer of Vizamyl, a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain. It estimates -amyloid neuritic plaque density in adult patients with cognitive impairment, who are being evaluated for Alzheimer’s disease or other causes of cognitive decline.

“If you don’t see any deposit in the brain, you are OK,” explained Dr. Eyal Mishani of the Nuclear Medicine Institute at Hadassah Medical Center. “If you do see some, then you are at risk. You can change your way of living to suspend or prevent [the onset of Alzheimer’s] or help mitigate the progression of the disease.”

He said that one can eat different foods, and do certain exercises or other types of training to suspend the progression of the disease.

The technology was tested during a series of clinical trials at Sheba Medical Center. Since announcing the production of the compound and bringing the test to Hadassah, a handful of tests have been conducted. Mishani is confident that it will eventually be used regularly. He also said that Hadassah will provide the compound to other medical centers interested in conducting the PET-CT examination.

Hadassah has a six-year contract to exclusively produce and market the compound.
Another benefit of the test is that it can be used to test people with early onset of Alzheimer’s undergoing clinical trials, which can then be compared to a second scan conducted at the conclusion of treatment.

“This will help us evaluate these treatments,” Mishani said.

The PET-CT examination will not be covered by the Health Ministry’s Services Basket but rather by private payment.

Originally Posted On: https://www.jpost.com/HEALTH-SCIENCE/New-non-invasive-brain-test-could-help-prevent-stymie-Alzheimers-597620

הפוסט Hadassah rolls out non-invasive brain test to help prevent Alzheimer’s en הופיע לראשונה ב-ש.ר.י.

As part of our core values, we have enshrined a commitment to an effective, safe and high-quality final product, so the end user, whether a patient, a treating physician or a medical center, can rely on our product with a high level of confidence.

Production is carried out in an isolator (Grade A), which is located in clean rooms, which were established with an investment of 13 million NIS, and the entire process has been adjusted and optimized to meet the highest quality and safety requirements.

GMP – Good Manufacturing Practice or in Hebrew “proper manufacturing conditions”, is part of the quality system, which audits the production sector in the pharmaceutical, medical device, and also food and cosmetics industries. GMP procedures are the guidelines that guide the production stages, which affect the quality of the final product.

Since each step of the process has a potential impact on the quality, efficacy and safety of the final product, Good Manufacturing Practices (GMP) include standards and guidelines that start from the selection and certification of raw material suppliers, through the production and quality control processes, to the storage of the finished product that has successfully passed the release tests and met all specifications. The certification indicates that the company has a high-level quality assurance system, the infrastructure is in order, and all production conditions and processes are adequate, controlled and meet the strict requirements of the Ministry of Health.

The GMP standard is a global standard, and as such is implemented in many places around the world. Many countries have enacted and established their own GMP procedures, but the basic characteristics remain the same and their goal is to ensure the quality of the medical product in order to maintain the health of the end consumer. In the State of Israel, the certificate is issued by the Ministry of Health’s Institute for Quality Control and Standards, which checks the company’s quality system, infrastructure, and production processes for compliance with international GMP procedures (with the reference point being the GMP guide of the PIC/S – Pharmaceutical Co-operation Inspection Scheme) and is recognized by the authorities of the European Union and other countries.

הפוסט S.R.Y. Company received GMP certification הופיע לראשונה ב-ש.ר.י.

^a Pauwels, EJNMMI, 2020, 47:3033; ^b Hou, EJNMMI Res. 2021, 11:55

Enhanced resolution due to the 18F isotope

Ideal half-life

Distribution to remote targets

High activity yield

Performance similar to 68Ga-DOTA-TATE

הפוסט 18F-NOTA-TIDE: Somatostatin analog, labeled with fluorine-18 הופיע לראשונה ב-ש.ר.י.

הפוסט PET 18F-mFBG imaging of hNET-expressing neural crest tumors en הופיע לראשונה ב-ש.ר.י.