SGS expands stability capacity at Mississauga, Canada lab

Published: 18-May-2017

The investment has seen the total storage capacity increase by nearly 200 cubic metres

SGS, analytical contract solutions provider, has expanded storage capacity at its laboratory in Mississauga, Canada, for the effective stability testing of new drug substances and products for full regulatory compliance.

The investment has seen the total storage capacity increase by nearly 200 cubic meters, to an overall total of approximately 450m3.

The additional capacity is split between six new chambers, which cover four standard storage conditions: 2–8oC -20oC, 30oC / 65% relative humidity, and 40oC / 75% relative humidity.

The chambers operate using a fully validated dual redundant cooling system with switch-over capability to ensure zero excursion in the event of mechanical failure. They are supported by gas-powered backup generators in the event of a prolonged power outage.

“We have seen a strong growth in demand for these services, from the biopharmaceuticals market and within the small molecule space,” said Michael Lindsay, Vice President of Life Sciences Canada.

“The additional capacity this expansion brings will allow us to reconfigure our existing assets to provide the standard frozen, refrigerated, accelerated and intermediate stability conditions, as well as to provide capacity for custom conditions.”

SGS elsewhere

Across its global network of facilities, SGS offers a wide range of studies to monitor drug stability, including long-term drug stability and accelerated stability studies, shelf life assessment, in-use studies, short-term temperature excursion studies and forced degradation assessments, according to ICH Q5C and ICH Q1B.

At the company’s laboratory in Wavre, Belgium, a new stability chamber has been installed, adding 84m3 of capacity, bringing the total capacity to more than 330m3.

With 21 laboratories offering contract analytical and bioanalytical services, SGS leverages its wholly-owned global network, present in North America, Europe, and Asia, to deliver harmonised solutions to large pharmaceutical and biotechnology firms.

In addition to testing services for the bio/pharmaceutical market, SGS also provides Phase I-IV clinical trial management, and services encompassing data management and statistics, PK/PD modelling and simulation, pharmacovigilance and regulatory consultancy.

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