Commissioning and Qualification (C&Q) for Facilities, Utilities & Process Equipment

Biologics

Client Overview

Biogen Inc. is a biopharmaceutical company that focuses on discovering, developing, manufacturing and delivering therapies to people living with serious neurological, rare and autoimmune diseases. The Durham facility is a 250,000-square-foot LSM plant with the capability to run up to 120,000 liters of bioreactor capacity.

Sequence Scope: Commissioning and Qualification

Sequence was awarded the scope for renovation of an existing manufacturing facility which included: Upstream/ Downstream Processing Suites, Buffer Prep, and new process equipment.Sequence developed the commissioning master plan for the Facilities, Utilities, and Process Equipment and performed commissioning services for twelve (12) seed train bioreactors and four (4) separate purifications systems, including development and execution of all commissioning documentation for all in scope process equipment. The Sequence team included 13 team members. Sequence Project leads were responsible for planning all activities for these resources, including scheduling across two shifts. This effort resulted in successful turnover to site validation and production without delays to production schedule.

Biogen

Durham, NC

Biologics

How Does the Commissioning, Qualification and Validation of Equipment Support Your Business?

Commissioning, Qualification and Validation are terms and processes related to the manufacturing of pharmaceutical or biotechnology products that are sometimes used interchangeably in the life sciences industry. Commissioning ensures that there is a systematic approach to ensuring that facilities, systems and equipment function as intended because they have been designed and installed to meet specific requirements. This is the first step in creating an efficient manufacturing environment that meets FDA specifications.

Equipment qualification goes a step further by creating a series of inspections, tests or assessments to ensure manufacturing, testing and sampling equipment is compliant and performs reliably. The qualification of equipment is vital to ensuring consistent, high-quality results in each and every product that is produced.

Validation is the documentation that establishes evidence that the commissioning and qualification process have been completed and provides assurance that products meet the predetermined specifications and quality characteristics that are intended.

Let Sequence guide you through your project by providing commissioning, qualification and validation services to address the system-level needs of your facility, enabling faster time-to-market.