Examination of non-sterile products tests for specified microorganisms

For certain product types, there is a requirement for testing to determine the absence of certain microorganisms. These specified microorganisms include pathogens and are known as indicator microorganisms. This is due to the fact that they may indicate the presence of other microorganisms from similar sources that are known to be hazardous for immunocompromised and other high-risk patients.

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LabConnect

Founded in 2002, LabConnect provides global central laboratory services including routine and esoteric laboratory testing, kit building, sample management and tracking, biostorage and scientific support services for biopharmaceutical and CRO clients. LabConnect currently has locations worldwide and central laboratory capabilities on six continents. LabConnect’s service suite includes: Specialized Testing. With more than 4,000 validated tests across our network, LabConnect can handle everything from general safety testing to the most complex molecular diagnostics and biomarker analyses. Specimen Tracking. LabConnect’s real-time specimen tracking service, SampleGISTICS™, follows the clients’ specimen samples from collection through logistics to receipt at any lab or storage location in the world.a

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Measuring the COVID Effect on Clinical Trials

whitePaper | June 27, 2022

As the world begins its transition into a postpandemic existence, it becomes possible to look back on the past two years and begin to quantify the effects that COVID-19 has brought.

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Choosing the Right Temperature Monitoring Solution

whitePaper | April 24, 2023

Globally, pharmaceutical regulators are becoming attuned to cold chain issues as biologics, vaccines, and other temperature‐sensitive products are commercialized for a global clientele. Many regulators now recommend including temperature monitoring technology in every cold chain shipment.

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Overcoming Pharma’s Launch Performance Problem

whitePaper | March 24, 2023

The prescription medicine market recovered from the wild swings of the early pandemic with renewed volume growth, driven by generics. COVID-19 vaccines and treatments have created a substantial market.

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The Never-Normal Future of Manufacturing

whitePaper | September 24, 2022

Let’s just say what we’re all thinking: 2020 was rough. It threw pretty much every element of our lives into disarray, and we suddenly had to become experts at navigating a new way of working, schooling and socializing.

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Advancing drug development using in silico modeling

whitePaper | June 22, 2022

The technologic and pharmacologic advances that have enabled researchers to take aim at previously untreatable diseases have contributed to an increase in the number of molecules in the development pipeline that are challenging and difficult to manufacture.

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Global Use of Medicines 2023

whitePaper | January 18, 2023

Reaching a post-pandemic era is an alluring prospect for almost everyone around the world after the disruptions of the past three years.

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Spotlight

LabConnect

Founded in 2002, LabConnect provides global central laboratory services including routine and esoteric laboratory testing, kit building, sample management and tracking, biostorage and scientific support services for biopharmaceutical and CRO clients. LabConnect currently has locations worldwide and central laboratory capabilities on six continents. LabConnect’s service suite includes: Specialized Testing. With more than 4,000 validated tests across our network, LabConnect can handle everything from general safety testing to the most complex molecular diagnostics and biomarker analyses. Specimen Tracking. LabConnect’s real-time specimen tracking service, SampleGISTICS™, follows the clients’ specimen samples from collection through logistics to receipt at any lab or storage location in the world.a

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