Scaling a cGMP Cell Therapy Manufacturing Platform from Prototype to Clinical Production
From Design Transfer to First Shipment in 5 Months, Earning FDA Advanced Manufacturing Technology Designation A fast-growing cell therapy company needed to transition a fully integrated, cGMP-compliant CAR-T manufacturing platform from laboratory prototype to low-volume production in preparation for clinical trial deployment. Ascential assumed turn-key manufacturing responsibility and delivered the first completed instrument within 5 […]
Delivering a First-to-Market Thermocycler with Real-Time DNA Amplification and Sequencing for Genetic Analysis
A genomics technology company had a concept for a novel real-time thermocycler that they wanted to bring to market. This special thermocycler would offer 96 individually controlled wells for greater flexibility and precision in DNA amplification and sequencing. Ascential provided full-scale development and contract manufacturing support, helping reduce development time while enabling a first-to-market platform […]
Engineering a Rapid Sepsis Diagnostic Platform to Commercial Scale
From Concept to Commercially Ready: Results in Under 10 Minutes, Time to Market Reduced by 20% A precision diagnostics company developed a cytometry-based sepsis probability platform using advanced machine learning analysis of white blood cells. To bring it to market, they needed an engineering and manufacturing partner capable of delivering the precision automation required for […]
Automating Pathogen Detection to Rapid Commercial Scale
From Concept to FDA Breakthrough A precision diagnostics client sought to dramatically reduce the time required to identify effective antibiotics for critically ill patients — without sacrificing accuracy or throughput. Ascential delivered a three-instrument automated system that achieved FDA Breakthrough Device Designation. Faster reagent dispensing across the full testing workflow 0 x Increase in throughput, […]
Contract Manufacturing for Medical Devices: 5 Critical Questions to Ask Before You Scale
Scaling a medical device from prototype to full production isn’t just about volume. It’s about precision, compliance, speed, and reliability. Whether you’re a startup moving toward deployment or an established OEM preparing to launch globally, the contract manufacturing partner you choose can either streamline your path to market or introduce risk at every stage. In […]
Top 10 Medical Manufacturing Trends Revolutionizing the Industry
The following is a synopsis of an article published in News Medical. Click here to read the full article. In the rapidly evolving world of medical manufacturing, staying ahead of trends is crucial for success. From advanced performance testing to the integration of machine vision and robotics, the landscape is transforming at an unprecedented pace. […]