Renovations & Labs Improve Patient Safety

Sanofi new drug product fill machine

A/Z CORPORATION

n By Kevin Chronley & Steven Biondo

s a global health care leader, Sanofi focuses on improving the lives of patients facing a range of challenges—from global diseases like malaria and influenza to orphan drug therapies for rare genetic disorders. Its 70-plus worldwide manufacturing sites include its sprawling campus in Framingham, Massachusetts, which is home to leading-edge biopharmaceutical product development and CGMP manufacturing. For more than a decade, A/Z has partnered with Sanofi to help transform its facilities to align with its evolving health care mission.

A/Z’s recent engagements with Sanofi have included a series of critical renovations to one of the manufacturing facilities on the Framingham campus to accommodate two new process development spaces: a drug product (DP) lab and a downstream processing (DSP) lab. Implementing these renovations required A/Z to mitigate impacts to Sanofi’s primary ongoing manufacturing operations and sensitive Current Good Manufacutring Practice (CGMP)-regulated environments requiring clean construction execution.

The DP lab component of the project required A/Z to design, plan, and convert two existing lab spaces into a single lab with an associated cold room. The new space accommodates key operations in Sanofi’s development process: raw material storage, equipment and parts

Sanofi new lyophilization equipment

preparation, formulation, material cart transfer, vial filling of the primary containers, stoppering the primary containers, lyophilization (freeze drying), and capping and crimping lyophilized loads.

In a nearby area, A/Z converted another lab space into the DSP lab. This work integrated another layer of complexity with the requirement to validate the space as CGMP. A/Z’s team implemented architectural fit/finish and HVAC renovations to fulfill the CGMP requirements that ultimately ensure that Sanofi’s products are safe and consistent for its patients. New equipment installations for the DSP lab included single-use mixers, chromatography systems, nano-filtration, bulk storage holders, a single-use UF/DF filtration skid, and an automated bottle/bag filling skid.