REMSCHEID, NORTH RHINE-WESTPHALIA, GERMANY, August 25, 2023
Our Journey to Excellence
We’re exhilarated to share that ATEM has successfully attained the Good Manufacturing Practice (GMP) Certification for our state-of-the-art cryo-electron microscopy (cryo-EM) laboratory. This not only sets a benchmark in our ongoing endeavors but also underscores our unwavering commitment to uphold the zenith of scientific standards in quality control applications. Our inaugural GMP qualified process is the Cell Line Characterization for Master Cell Banks, instrumental in the production of biologic drugs.
This landmark accomplishment was catalyzed by our fruitful collaboration with the globally renowned Charles River Laboratories. Their unparalleled expertise in biologics testing, fused with decades of GMP proficiency, was pivotal in making this venture a reality.
A Symbiotic Partnership: Carving New Frontiers
Our alliance with Charles River is more than just a collaboration; it’s a fusion of two worlds. By intertwining Charles River’s time-tested GMP expertise with our avant-garde technological prowess in electron microscopy, we’ve sculpted an epitome of operational excellence and stringent quality assurance.
Embracing the Digital Transformation:
Navigating the realms of cryo-EM, we’ve digitalized our processes end-to-end. From capturing images to the intricacies of data analysis, we ensure strict accordance to the ICH5 guidelines for viral safety evaluations. Traditional flu-screen methodologies, with their limitations in image contrast, posed significant challenges in the reliable identification and quantification of viral contaminants. Not only the improved image quality but also the inherently more efficient process allows fast turnaround times – meeting the pharmaceutical industry’s need.
Adding another feather to our cap, our digitized workflows provide complete traceability—a paramount feature ensuring transparency and bolstering trust in our services besides external audits.
Furthermore, our transition to digital imaging in cryo-EM offers superior clarity, capturing intricate specimen details with unrivaled precision. This digital advantage lays the groundwork for leveraging Artificial Intelligence (AI). AI, particularly adept at repetitive object detection tasks, significantly reduces the risk of human errors, ensuring consistent and accurate results. This integration signifies not just an enhancement but a revolution, as we’re now gearing up to turbocharge our CLC and BHA viral contamination studies, heralding a future of swifter, more reliable processes.
Link to publication review
From Analog to Digital Images
In the domain of cryo-electron microscopy (cryo-EM), the transition from traditional fluorescence screening (flu screen) to digital imaging has marked a pivotal evolution in data clarity and precision. Flu screens, while effective for certain applications, are hampered by inherent limitations in image contrast, making the discernment of minute details a challenge. This ambiguity can lead to errors during analysis, especially when identifying and quantifying nuanced structures or anomalies. On the other hand, digital images in cryo-EM offer a superior resolution, capturing intricate details with remarkable clarity. The sharpness and enhanced contrast of digital imagery facilitate more accurate and reliable analyses, reducing potential errors. With each pixel crisply defined and data stored in digital format, computational tools can further process and analyze the images, ensuring consistent results that are less subject to human interpretation biases. Thus, the shift to digital imaging in cryo-EM not only optimizes the visualization of specimens but also significantly diminishes the likelihood of analytical errors.
Expanding Our Spectrum with Bulk Harvest Analysis and More
Our quest for excellence doesn’t rest. As we cherish our milestones, we’re already setting our sights on the future. With the forthcoming rollout of Bulk Harvest Analysis (BHA), we’re poised to introduce a plethora of analytical methods through cryo-EM, released in various phases. Offering a comprehensive suite tailored for diverse scientific requirements.
AS WE CONTINUE TO INNOVATE AND REDEFINE STANDARDS IN ANALYTICAL ELECTRON MICROSCOPY, WE WARMLY INVITE YOU TO BE PART OF OUR EXPEDITION. IF OUR OFFERINGS HAVE PIQUED YOUR CURIOSITY OR IF YOU’RE CONSIDERING COLLABORATION,
WE’D LOVE TO HEAR FROM YOU. TOGETHER, LET’S SCULPT THE FUTURE OF CRYO-EM MICROSCOPY AND ADVANCE THE FRONTIERS OF SCIENCE.