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 […]
Developing a Scalable Next-Generation Sequencer with Proprietary Chemistry
Integrating Complex Subsystems for Class II IVD Compliance A leading life sciences company needed a fully automated, high-precision sequencing system capable of handling sensitive reagents, managing complex multi-channel fluidics, and integrating third-party components for efficient sequencing based on proprietary chemistry. The system had to support strict regulatory compliance for Class II IVD and IEC 61010 […]
Transferring a Legacy Urological Device Production Line to the EU With Zero Disruption
From Fragmented Legacy Program to CE-Compliant, Fully Operational EU Transfer A Fortune 100 medical device manufacturer needed to transfer a legacy U.S. production line for a single-use urological diagnostic device to a European Union facility without interrupting ongoing operations, compromising product quality, or missing regulatory milestones. Ascential assumed end-to-end ownership of the program and delivered […]
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. […]
ISO 13485: What Early-Stage Medical Device Companies Need to Know
For early-stage medical device companies, quality management systems (QMS) often feel like a “later-stage problem.” In reality, they are a prerequisite for regulatory approval and commercialization. Manufacturing timelines largely determine how quickly patients can access life-saving devices. So, regardless of production goals, budget, or program scope, early concept and design teams must account for International […]
Sustaining a High-Throughput Genomic Analysis Platform for Long-Term Market Success
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, […]
Automating Pre-Analytical Sample Preparation to Clinical 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, […]
Delivering a Faster Path to Market
Delivering a faster path to market: Staying ahead of the competition in 2025
Cell Therapy Manufacturing Services: Reducing Time to Market with Automation
As cell and gene therapies continue to revolutionize the healthcare landscape, manufacturers face a growing number of challenges in scaling production and bringing treatments to market efficiently. With patient-specific treatments and complex workflows, cell therapy manufacturing requires unparalleled precision, quality, and compliance. To overcome these hurdles, more companies are turning to cell therapy contract manufacturing […]