Inside the Treatment Supplies Management Bureau

In a laboratory in an industrial area outside Canberra, workers spray fake blood on surgical masks to see how well they prevent blood. Another lab uses a large machine to test the ability of more protective types of masks to spray finely concentrated mist to protect against aerosols.

Since the COVID-19 pandemic began in January 2020, thousands of such masks have been tested at the Treatment Product Management Headquarters. Safe from coronavirus.

“We had so many masks to test that we were running two shifts seven days a week,” says TGA professor John Skelitt.

Australian medical regulators have become famous over the past year thanks to their efforts to approve the coronavirus vaccine. However, as Professor Skelitt said earlier this year, vaccine approval accounts for 20% of the work. It’s not too much.

“There are more profiles in this place, for better or for worse,” he said.

“I stand in front of the media, but behind the scenes are the people testing my mask.”

The regulator is Sydney Morning Herald And Age Shows the work being done by 750 scientists, medical professionals, engineers and pharmacists, as well as former police officers, spies and lawyers.

“This is more than just a group of scientists,” says Professor Skelit.

TGA plays an important role in compliance, preventing products from being mispromoted or misused, and helping to crack down on black market imports and backyard manufacturing.

But science is a big part of that job.

It regulates pharmaceutical and medical device, cell and tissue technologies. This includes hundreds of thousands of products, including asthma inhalers, surgical implants, crowns, ibuprofen, wound dressings, hand sanitizers, and test kits for the virus that causes COVID-19.

Regulators examine the product before it is used, but continue to monitor and research medicines and devices after it has been used. We have laboratories and equipment to inspect medical devices and products that are unique to this region.

“We are probably among the top six to seven regulators in the world, including the fact that we have a fully set up laboratory,” says Professor Skerritt.

In the chemistry laboratory, all kinds of drugs, from normal to illegal, are tested and the actual chemical composition is known. There is an artificial stomach to test the absorption of the drug. In another room, there is a seemingly unconventional and expensive machine where you can examine the chemical characteristics of the compounds in various medicines.

Engineering labs also test more common products such as condoms.

Professor Skerritt said that during the HIV / AIDS epidemic from the mid-1980s, it was imperative to work reliably without leaking or breaking. So TGA got a machine to test by inflating air to a certain point. It’s a work that is still done today, where you put a condom on a white stick inside a beige machine and inflate it until it tears.

2 vaccines down, 15 remaining

A shift is required for the COVID-19 pandemic. New technologies, including mRNA vaccines, provide new tests.

Molecular biology experts, virologists, biochemists, and immunologists have performed about six different tests on two approved COVID-19 vaccines (AstraZeneca and Pfizer) to meet stringent criteria. I often work seven days a week to make sure I am.

In cell culture labs, scientists grow cells to test mRNA vaccines. These vaccines work by giving cells recipes that make proteins that the body makes antibodies to. This provides the body with a shield against viruses.

TGA experts use special dyes and machines to monitor cells and ensure that the process works. It requires a certain kind of expensive machine, and regulators already had it, but Professor Skellit says it makes sense to buy another.

“It is almost inevitable that Australia will somehow increase its ability to produce messenger RNA vaccines (mRNAs), and no one knows that it could become flu or measles in the next few years.” Says Professor Skelit. “Therefore, we need to stay ahead of the game to get the technology to test these vaccines.”

Professor Skellit, who himself has worked in the lab for 20 years, emphasizes that the process of developing these vaccines is not in a hurry. Rather, it is the most intensive R & D investment in the last 50 or 100 years, with the exception of World War II and the Space Race.

Once the pandemic took hold, all major medical research facilities and pharmaceutical giants around the world turned to vaccine development with billions of dollars in government support.

“Any medical scientist of reasonable quality has been turned to work on vaccine research,” says Professor Skelitt.

“Yes, the time frame has been shortened, but in reality, hundreds of thousands to hundreds of thousands of people are working on these vaccines.”

So far, TGA has approved two COVID-19 vaccines, but Professor Skelitt says this is just the beginning of a regulator’s commitment to a pandemic.

“You have approved two vaccines, but you have only 15 more left,” he says, offending his compatriots.

But it’s not just about vaccines. Professor Skerritt hopes that more treatments and drugs for the disease will emerge in the not too distant future.

“Apart from more vaccines, the next big thing for COVID is to focus more on medicines,” he says. “They are all different types of medicine, and they are all medicines that need to be injected, even those that are taken as tablets.”

Professor Skerritt hopes that treatments and tests will be developed within the next few months to years.

“People are interested in a new approach. For example, can you put a machine that somehow kills a virus in the corner of a room? As we already see such wild and quirky things. It’s starting to be sought after, “he says.

“But I expect that a major focus of our work will be on 2nd and 3rd generation COVID vaccines and treatments.”

Stay on top of the most important pandemic-related developments with the new Coronavirus update. sign up Receive a weekly newsletter..