Process Development and Service Lab

This laboratory is dedicated to addressing key challenges in process development and manufacturing for biopharmaceutical clients in China. Alioth’s facility integrates a membrane materials R&D center, a process development lab, and a pilot-scale lab. Guided by the DbA (Design by Application) philosophy, we collaborate closely with domestic biopharmaceutical partners to develop new technologies and products that support drug discovery, pilot studies, and scale-up production. Equipped with advanced process development and pilot-scale systems, and staffed with experienced technical specialists, we provide comprehensive support in technical consultation, process development, product training, and troubleshooting—accelerating the translation and advancement of biopharmaceutical projects.

Validation Service Lab

The Validation Laboratory provides comprehensive validation services—including Bacterial Retention Testing, Extractables & Leachables (E&L), Compatibility Studies, Product-Wetted Integrity Testing (PWIT), and Binding Studies—for pharmaceutical manufacturers. It also conducts in-house product validation and generates data to support validation guidelines.

Operating under an ISO9001 quality management system, the laboratory ensures data authenticity, accuracy, and traceability in compliance with data integrity principles. Staffed with experienced validation specialists, the laboratory employs scientifically sound methods to deliver filtration process validation that meets global regulatory standards.

In line with customer-focused quality principles, we offer end‑to‑end validation support, including regulatory interpretation, process/report assessment, and validation services for both Alioth and third‑party products.

Equipped with advanced instrumentation such as LC‑MS/MS, GC‑MS, steam‑in‑place (SIP) systems, and particle counters, the laboratory provides reliable, audit‑ready validation data.