Tech, ExplainedHealthtech and life sciences
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Lab instruments and informatics

What is really in the tube?

1 Supplies are ordered2 Sample is prepared3 Instruments test it4 Data is collected5 Result is recordeddelivers the suppliesloads the samplesends the readingsfiles the resultLabsupplies procurement+Bioreactorand bioprocessing+Chromatography andmass spectrometry+DNA sequencer+Cell analysisand lab imaging+Lab instrumentintegration+Laboratoryinformationmanagementsystem (LIMS)+Procure-to-paysoftware↗ FINANCE ANDACCOUNTING SOFTWAREPharmaceuticalreference standards↗ NONPROFIT SOFTWAREBioinformaticsdata platform↗ COMPUTATIONALDRUG DISCOVERYQualitymanagement system(QMS) for pharma↗ PHARMA MANUFACTURINGA chemist at a drug company'sresearch laboratory in HyderabadA checked result, onrecord for an inspectorYears later, in the factory: the quality-control laboratory tests every batch of the finished medicine on thesame kind of instruments.CONCEPTS IN THIS SCENEGxP complianceSelf-driving labBiologicsFirmwareGenomicsSystem of record1 Suppliesare ordered2 Sampleis prepared3 Instrumentstest it4 Datais collected5 Resultis recordeddelivers the suppliesloads the samplesends the readingsfiles the resultLab suppliesprocurement+Bioreactorandbioprocessing+Chromatographyand massspectrometry+DNAsequencer+Cellanalysis andlab imaging+Labinstrumentintegration+Laboratoryinformationmanagementsystem(LIMS)+Procure-to-paysoftware↗ FINANCE ANDACCOUNTINGSOFTWAREPharmaceuticalreferencestandards↗ NONPROFITSOFTWAREBioinformaticsdata platform↗ COMPUTATIONALDRUG DISCOVERYQualitymanagementsystem (QMS)for pharma↗ PHARMAMANUFACTURINGA chemist at a drugcompany's researchlaboratory in HyderabadA checked result, onrecord for an inspectorYears later, in the factory: the quality-control laboratory tests every batch of the finished medicine on thesame kind of instruments.CONCEPTS IN THIS SCENEGxP complianceSelf-driving labBiologicsFirmwareGenomicsSystem of recordA chemist at a drug company'sresearch laboratory in Hyderabad1 Supplies are orderedLab supplies procurement+Procure-to-pay software↗ FINANCE AND ACCOUNTING SOFTWARE↓ delivers the supplies2 Sample is preparedBioreactor and bioprocessing+↓ loads the sample3 Instruments test itChromatography and mass spectrometry+DNA sequencer+Cell analysis and lab imaging+Pharmaceutical reference standards↗ NONPROFIT SOFTWARE↓ sends the readings4 Data is collectedLab instrument integration+Bioinformatics data platform↗ COMPUTATIONAL DRUG DISCOVERY↓ files the result5 Result is recordedLaboratory information managementsystem (LIMS)+Quality managementsystem (QMS) for pharma↗ PHARMA MANUFACTURING→ A checked result, on record for an inspectorYears later, in the factory: thequality-control laboratory testsevery batch of the finished medicineon the same kind of instruments.CONCEPTS IN THIS SCENEGxP complianceSelf-driving labBiologicsFirmwareGenomicsSystem of record
A chemist's new molecule is checked in the laboratory, from ordering supplies and preparing the sample, through the instruments that test it, to the result recorded in the LIMS without copying by hand.
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Lab instruments and informatics are the machines that test, read and grow samples in a research or quality-control laboratory, and the software that runs the laboratory around them. Informatics here means the software that records samples, results and instruments. Drug companies, research institutes and universities buy them. The makers of these instruments are some of the largest companies in science, and several of them write much of their instrument software in India, in cities such as Bengaluru and Hyderabad.

Imagine a chemist at a drug company's research laboratory in Hyderabad. A computer model has proposed a new molecule, through computational drug discovery. She makes 50 milligrams of it. Now the laboratory must check what is really in the tube. Is it the molecule she meant to make? How pure is it?

First, she needs supplies: solvents, columns and vials. Her laboratory orders them through lab supplies procurement, which compares prices from several suppliers. If the medicine were a biologic, made by living cells, the cells would first be grown in a bioreactor. Medicines of this kind are explained in biologics.

Next, the sample goes onto the instruments. The most important ones are described in chromatography and mass spectrometry. The chromatograph separates the sample into its parts. The mass spectrometer then identifies each part by weighing its molecules. Here the result is clear: 98.6% of the sample is the intended molecule, and one small impurity makes up most of the rest. Other laboratories use a DNA sequencer to read genes, or cell analysis and imaging instruments to count cells and photograph them.

Then the result has to be recorded without being copied by hand. Lab instrument integration software takes each result from the instrument and sends it to the laboratory's main system. In a drug maker's quality-control laboratory, that main system is a laboratory information management system (LIMS). The LIMS records each sample, each test and each result. Under GxP rules, a regulator's inspector may ask to see any of these records years later.

Years from now, if the molecule becomes a medicine, a factory's quality-control laboratory will test every batch with the same kind of instruments. The next frontier is the self-driving lab. In such a lab, an AI model directs the instruments and robots. It designs each experiment, runs it, reads the result and chooses the next one, with no person needed between the steps.

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