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 […]
Scaling Manufacturing for an Implantable Combination Device
From Early Clinical Production to Commercial Scale A global medical device manufacturer needed to scale production for a breakthrough implantable drug-delivery combination device used in the treatment of non-muscle-invasive bladder cancer. The program required a compliant, scalable manufacturing operation capable of supporting both medical device and pharmaceutical regulations while reducing production bottlenecks and accelerating output. […]
Automating Oligonucleotide Synthesis for Scalable, Standardized Production
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, […]
Pharmaceutical Manufacturing: How to Improve Efficiency and Compliance
Pharmaceutical manufacturers face ever-increasing complexity—from rigorous regulatory demands to the need for rapid innovation. For engineers and executives driving pharma R&D and production, the integration of advanced pharmaceutical manufacturing solutions isn’t just an operational upgrade; it’s a strategic imperative. Through a combination of state-of-the-art automation, robust quality systems, and agile process design, manufacturers can ensure […]