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. QMS requirements are upstream of design freeze, clinical trials, and regulatory submissions. Delaying implementation creates retroactive documentation risks that can derail timelines more than proactive compliance ever would. So, […]
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. […]
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 […]