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Inside the Therapeutic Goods Administration

In a laboratory in an industrial Canberra suburb, a worker sprays fake blood on surgical masks to see how well they protect against blood. In another laboratory, a large machine is used to spray a high quality, concentrated mist over additional protective types of masks to test their ability to protect against aerosols.

Thousands of masks have been screened in this way at the Therapeutic Items Administration headquarters since the start of the pandemic in January 2020. At its peak, it was running round the clock to ensure that the personal protective equipment used by frontline workers kept them safe.

“We were working two shifts, seven days every week, because we just had so many masks to check,” says Professor John Skerritt, head of the TGA.

Australia’s medical regulator has become a family icon over the past 12 months because of its work approving vaccines. However, as Professor Skerritt said earlier this year, approving vaccines was only 20 per cent of his work.

“This place has got a very high profile, for good or dangerous,” he said.

“I stand out in front of the media, but it’s actually the people who find themselves testing my masks who are working hard in the background.”

The regulator opened its doors to the Sydney Morning Herald and The Age to point to the work being achieved by 750 scientists, medical experts, engineers and pharmacists, but also former law enforcement officers, detectives and legal professionals.

“It’s not just a group of scientists,” says Professor Skerritt.

An important function of TGAs in compliance is to guarantee that goods are not unfairly marketed or misused, and to help crack down on black-market imports or yard construction.

However science is a big part of his work.

It governs medical medicine and units in addition to the knowledge of any cell or tissue. This includes thousands of products including bronchial asthma inhalers, surgical implants, dental crowns, ibuprofen, wound dressings and hand sanitisers – as well as test kits for the virus.

The regulator appears on products before their use, but it continues to watch and analyze the drug and units after they are in use. Uniquely for the region, it is equipped with laboratories and equipment to test medical units and goods.

“We see most likely within the high six or seven regulators around the world, and this reflects the fact that we have got a fully set-up laboratory,” says Professor Skerritt.

In its chemistry laboratories, all kinds of drugs are tested – from extraordinary to illegal – to find out their exact chemical structure. There is a synthetic stomach to check how properly the medicine is absorbed. In another room are deceptively nondescript but expensive machines that can produce chemical fingerprints of compounds in various drugs.

Professor Skerritt said that during the HIV/AIDS epidemic from the mid-nineteenth century it was very important to guarantee the work without leaking or breaking. So the TGA found machines that tested them by inflating the air to a certain level. This is work that is still done today, condoms placed on a white stick inside a beige machine and inflated until bursting.

Two Vaccines Down, 15 Still Left

The pandemic needs a change. With increasing applied science, along with mRNA vaccines, come new tests.

Professional molecular biologists, virologists, biochemists and immunologists are conducting about six completely different assessments on the 2 approved vaccines (AstraZeneca and Pfizer), usually seven days each week, to make sure their strict requirements are met. work.

In cell culture laboratories, scientists develop cells to test for mRNA vaccines. These vaccines work by giving cells a mechanism to make a protein against which the body will make antibodies. This gives protection to the body from the virus.

TGA’s specialists monitor the cells using special dyes and machines to make this possible during work. It requires a special kind of expensive machine, and while the regulator already had one, Professor Skerritt says it makes sense to buy a second one.

“It is almost inevitable that Australia will have additional functionality somehow to make messenger RNA vaccines (mRNAs); and who knows, in many years’ time it may be for the flu or measles,” says Professor Skerritt. Huh. “So we have to be ahead in the game to figure out how to test these vaccines.”

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