Liu Huafen: Mass Spectrometry Localization Enterprises Realize a Closed Loop of Standardized Solutions and Products

Recently, Gloria Spectrum officially released its first domestic clinical mass spectrometry detection system, CalQuant-S, under its own brand, completing the closed loop of independent productization of its solutio.

Professor Liu Huafen, Founder and CEO of Gloria

5 years of development, complete the closed loop of independent products for clinical mass spectrometry standardization solutions

On March 15 this year, the CalQuant-S liquid chromatography tandem mass spectrometry detection system (Zhexi Machinery Note 20222220116) was officially approved by the Zhejiang Provincial Drug Administration for marketi.

In fact, since Liu Huafen returned to China in 2017 to create Gloria, he has set two major business development pat.

"At the beginning of the establishment, we first cooperated with Dean and established two central laboratories around clinical mass spectrometry and multi-omi.

In fact, many years ago, when Liu Huafen was in charge of the market development of clinical and innovative applications in SCIEX North America, she first proposed the "total solution" in the mass spectrometry indust.

At the same time of building the two major technology platforms, Gloria also developed a business model for testing servic.

CalQuant-S: the thoughtful choice for clinical mass spectrometry laboratories

Talking about why CalQuant-S was launched, Huafen Liu said: "Calais CalQuant-S inherits the same hardware technology of SCIEX, and has very obvious technical advantages in clinical application: the skin is durable, high sensitivity, and the required The sample size is small, the accuracy is high, and the anti-pollution ability is stro.

In addition to mass spectrometry, Gloria Spectrum has recently launched a supporting sample pretreatment syst.

Clinical application of CalQuant-S

CalQuant-S has some core competencies in mass spectrometry applications: high sensitivity, less sample volume, trace detection,e.

The first is hormone testi.

The second example is the detection of dihydroxyvitami.

The third is hypertension diagnostic da.

If the mass spectrometry detection method is used, clinicians can identify the type of hypertension with accurate detection data, and then achieve the right medicine, and finally achieve precise treatme.

　　Process standardization, 4 points to establish a benchmark in the clinical mass spectrometry industry

　　"Since its establishment in 2017, Gloria Spectrum has always hoped to become a benchmark in the clinical mass spectrometry industry, and also hopes to benefit hospitals with an overall soluti.

　　 The instrument hardware is reliab.

　　 The methodology should be as simple as possib.

　　 The detection result data processing is intellige.

Before data automation, the experience of operators determines whether data processing will be skew.

In order to reduce the uncertainty caused by human factors, Gloria has developed the automation software CalQ.

This is an integrated management software tailored for clinical mass spectrometry laboratories, which can realize data kanban, data security, data management, automatic reporting, intelligent quality control, system deviation,e.

CalQMS can simplify a lot of tedious paperwork and make the daily management of clinical mass spectrometry laboratories easi.

　　 Daytime quality contr.

Day-to-day quality control guarantees no false resul.

CalQMS software is specially designed for clinical laboratories, embodying the core concept of quality control, integrating clinical inter-laboratory and indoor management systems, reagent consumables management systems,e.

According to statistics, the error rate of the Gloria Lab equipped with this software is only a few ten thousandths, which truly achieves high-precision experimental quality contr.

　　Styles of Gloria Score: Do It Then Say It

　　"In order to develop instrument hardware, we must first have a corresponding team, and this is completely different from the original inspection service," said Liu Huaf.

As early as 2020, Gloria Spectrum began to build a mass spectrometry R&D team, including automation and follow-up products, which are all in charge of this hardware te.

At present, the team has expanded to 30 people, including experienced engineers in the mass spectrometry field and senior practitioners in the IVD indust.

"Only by combining mass spectrometry research and development with IVD industry thinking can we solve the problem of scientific research attributes, open up the mass spectrometry-related industry chain, and realize product automation, high throughput, and new technologies derived and iterative," said Liu Huaf.

　　"We work in a relatively low-key mann.

The team building and site construction process have not been disclosed, and they are all carried out in a low-keymann.

The industry does not know that our mass spectrometry team has been established for so lo.

This is the >
" Liu Huafen sa.

　　Uphold the original intention of starting a business and hope that mass spectrometry can really enter the hospital

　　In the overall planning of Gloria Spectrum, hardware is an important part of the product li.

The launch of CalQuant-S complements the overall solution for clinical mass spectromet.

Liu Huafen said: "In the future, we will continue to improve the mass spectrometry-related industry chain, and launch automated, high-throughput and derived new technologies and new products that are constantly iterat.

"

　　In 2021, the development of the IVD industry will further promote the upsurge of clinical mass spectromet.

While it is booming, there will also be some bubbles, such as some overheated capital, idealizing some rational thin.

After such twists and turns, everyone may look at the industry more calm.

　　"I'm very confident in the future of clinical mass spectromet.

Mass spec itself is a very powerful tool that does not require antigen-antibody reactions while monitoring many compounds with high sensitivi.

In the IVD industry, you may have heard of "Bad Blood" by Elizabeth Holmes Ca.

Why did she fail? Because she used the wrong detection technolo.

But this concept can be realized in the future, not with immunological instruments, but with mass spectrometry instrumen.

Of course, it will not be as cheap as her 'flickering', because the core of mass spectrometry is zero The precision machining of components and the investment in research and development are very hu.

　　Now there is a policy orientation of domestic substitution, and the whole industry is promoting localizati.

In this regard, Liu Huafen also talked about his vie.

There is an important step in domestic assembly in the process of localization; it is an indispensable step for the industry to reach the clin.

why? At present, participants in many industries also want to start from scratch and borrow a lot of imported technologies, but mass spectrometry instruments need to accumulate iterative.

The products of several major foreign mass spectrometry companies have been iterated since the 198
After decades of development, they have reached today's instrument performance before they can enter the clin.

If it is completely original, the original instrument may not meet the clinical needs at once, but it can start from the areas where the requirements for sample size and sensitivity are relatively loose, such as food and environment; but if it is used for clinical diagnosis, it needs to have limited To achieve the quantitative analysis capability of pg/ml level in human blood samples, the requirements for the instrument are very stri.

　　Clinical tests are "people's lives at stake", and the test must be accurate, and the test results directly affect the patient's treatment pl.

In this case, the accuracy requirements of the instrument are very hi.

Mass spectrometry instruments built by enterprises must be slowly polished and iterated through other application fields, and the reliability of the instruments can meet the requirements before they can reach the clin.

Because in all application areas, clinical is the last basti.

In the field of scientific research, the result is not good, and the article cannot be published; in the field of pharmaceuticals, it is easier to measure the concentration because it is exogeno.

The clinical field is the most difficult, with high risk taking, complex matrices, and minimal sample volum.

For example, in the detection of metabolic genetic diseases in newborns, the sample is a blood spot, which only comes from 20 microliters of blo.

　　Since the establishment of Gloria Spectrum, the core business has been developing in parallel on the two paths of multi-omics innovation markers and clinical mass spectrometry industrializati.

With the release of a new generation of high-end domestic clinical mass spectrometry detection system CalQuant-S, Gloria Spectrum has realized the overall clinical mass spectrometry solution and has truly opened up all lin.

　　"In the future, Gloria Spectrum will continue to uphold the original intention of starting a business, continue to consolidate the industrialization of mass spectrometry, and constantly iterate new produc.

It is hoped that clinical mass spectrometry can truly enter the practical application scenarios of hospitals, so that doctors' work can be precise and simplifi.

In the future, Gloria Spectrum will Open up overseas markets, let Chinese brands go to the world, and realize Gloria's goal of 'quality wins, dreams and technology lead the future' as soon as possible," said Liu Huaf.