Agno Pharma’s Particle Sciences Achieves ISO 13485:2016 Certification
What It Means for Combination ‑ Product Sponsors
Agno Pharma’s Particle Sciences facility in Bethlehem, Pennsylvania has been certified to ISO 13485:2016 by NQA on April 2, 2025, signaling device‑grade quality discipline for implants, prefilled components, and drug–device interface manufacturing. The certification elevates audit readiness, accelerates tech transfer, and de‑risks late‑stage scale‑up for programs moving toward registration.
The Bethlehem site completed an independent registrar audit and earned ISO 13485:2016 certification, the global benchmark for medical‑device quality management systems. The scope covers design, development, and manufacturing workflows relevant to device components and combination products produced at Particle Sciences. This is a facility‑level certification of the quality system—it does not confer product approvals. For sponsors, that distinction matters: the certification validates the governance, documentation, and controls behind the work and shortens supplier qualification timelines.
The practical upshot is straightforward. If you are qualifying vendors for device or combination‑product components, you can treat the Bethlehem facility as a device‑grade node within Agno Pharma’s CDMO network. That gives program teams a single partner that understands how drug and device disciplines intersect, spanning formulation, component fabrication, and analytical validation under one quality umbrella.
Why ISO 13485 moves the needle
ISO 13485 certification evidences a closed‑loop quality system purpose‑built for medical devices and combination products. Expect documented design controls, risk management aligned with ISO 14971 principles, supplier quality oversight, validated processes, and a data‑driven CAPA engine. The result is end‑to‑end traceability—from raw materials through finished components—that stands up to customer audits and regulatory inspections across the U.S. and EU.
The business value shows up in cycle time and risk reduction. Vendor onboarding is faster because the QMS has already been stress‑tested by a registrar. Tech transfer becomes less brittle because change control, equipment calibration, preventive maintenance, and batch record governance are embedded in daily operations. As FDA’s Quality Management System Regulation (QMSR) aligns U.S. device expectations with ISO 13485 in 2026, sponsors will increasingly expect suppliers to meet that same bar. Particle Sciences is already operating at that level, which helps future‑proof programs headed toward MDR/IVDR and U.S. submissions.
What’s in scope at Bethlehem—and why it matters
The certified scope supports the design, development, and manufacturing of device components and drug–device interfaces used in combination products. In practice, that includes engineered parts for implants, prefilled or delivery components, and the associated analytical methods that link component performance back to product requirements. Sponsors benefit from standardized documentation sets—Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR)—and validation protocols that withstand external review.
Because Particle Sciences sits within Agno Pharma’s integrated CDMO footprint, teams can couple device‑grade component work with formulation development, complex injectables support, and analytical services under harmonized change control. That consolidation reduces handoffs, minimizes comparability risk, and streamlines issue resolution as programs move from feasibility to engineering runs and into clinical manufacturing.