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Project Ousia: Automation Verification

RNAi Therapeutics, Oligonucleotide Drug Substance


Alnylam is a biopharmaceutical company developing novel therapeutics based on RNA interference (RNAi). The Alnylam Oligonucleotide Drug Substance Manufacturing Facility in Norton, MA consists of a new 230,000 SF building. The building houses multiproduct, commercial stage biopharmaceutical manufacturing with a sustainable pipeline of RNAi‐based medicines.

Sequence Scope

Manufacturing Train 1

This new facility build-out included the need for C&Q services for the Process Automation System and Building Automation System that collectively monitor and/or control the entire facility. This includes HVAC, clean & dirty utilities for the plant, and manufacturing equipment within the Train 1 suites.

Sequence was responsible for developing functional and design specifications to define general and sequential functionality to automate the processes to produce RNAi (RNA Interference) therapeutics followed by turn-key Automation verification and qualification for all utilities, process equipment, and ancillary equipment on a Rockwell PlantPAX platform.

The effort included development and execution of all life cycle documentation (FATs, IV, OV, IQ, OQ).

The project was completed successfully on time and under budget to allow Alnylam to continue development and manufacturing of life changing RNAi therapeutics.

Life Impact

  • The Alnylam facility develops innovative therapeutics based on RNA interference. RNAi therapeutics developed by Alnylam will target a number of illnesses including TTR, haemophilia, hepatic porphyrias, beta thalassemia, hypertension and liver infections. Products manufactured at the Norton facility are sold across the world. Source

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