Aluris Sciences

Overview

Aluris Sciences is a contract manufacturing organization (CDMO) built for complex life science, in vitro diagnostic, medical device, drug-device combination, drug, and lyophilized product programs. The company operates two state-of-the-art facilities and has delivered over 1,000 projects to 200+ life science partners.

Core Services

Manufacturing & Formulation:

• Reagent manufacturing
• Combination product manufacturing (drug-device, drug-biologic, device-biologic assemblies)
• Lyophilization services
• Fill and finish operations
• Terminal sterilization services
• Kitting and packaging

Development & Quality:

• Formulation development services
• Analytical method development
• Quality control and testing
• Technical transfer (including complex combination product transfers)
• cGMP storage and logistics

Regulatory & Compliance

Aluris maintains expertise in managing the regulatory complexity of combination products under FDA 21 CFR Part 3, with a regulatory team supporting product classification and submission strategy. The company's quality system addresses both drug cGMP and device QSR requirements simultaneously. Technical transfer processes begin with comprehensive gap assessments across constituent parts before transfer activity begins.