Sequence is celebrating our 20th Anniversary!

Watch the Video
All Projects

Project Key: Commissioning and Equipment Qualification

Cell & Gene Therapy


Headquartered in Cambridge, MA, Brammer Bio’s facility includes a 66,000-square-foot Phase III and commercial CGMP viral vector manufacturing site. This was facility was designed to accommodate spatially segregated viral vector processing in dedicated production suites to support early phase clinical trials. In 2019, Brammer Bio was purchased by Thermo Fisher Scientific.

Sequence Scope

The client renovated an existing biologic manufacturing facility into a new gene therapy viral vector manufacturing facility. Sequence scope included CQV for equipment including but not limited to incubators, biosafety cabinets, single-use bioreactors, single-use mix tanks, depth filtration, single-use chromatography skids, single-use TFF skids, drug product filler and drug product isolator.

Sequence was responsible for developing project plans for facilities, utilities, and process equipment followed by risk assessments, site procedures, and start up efforts to qualify the site to allow for production of viral vector products.

Life cycle documentation was developed and executed to demonstrate proper functionality per specifications for systems such as Membrane-based WFI generation skid, VHP, HVAC, Compressed Gases (O2, N2, CO2, Air), and indirect impact systems (tempered water, plant steam, chilled glycol, etc.

Life Impact

  • Thermo Fisher produces and tests viral vectors for cell and gene therapy with adherent and suspension cell culture processes, a variety of chromatography and filtration purification processes and a state-of-the-art isolator and integrated fill system.

  • With years of experience producing cGMP viral vectors, they support a broad range of viral vector manufacturing platforms for gene and gene-modified cell therapies and vaccines including AAV, Adenovirus, Lentivirus, HSV, and Retrovirus. Source

Get Started

How can Sequence support your project success?

Contact Us
  • Sequence, Inc. Global Headquarters
    1400 Perimeter Park Drive
    Morrisville, NC 27560

  • Northeast Office
    1 Speen Street, Suite 120
    Framingham, MA 01701

Sign up for our email newsletter
white sequence logo

Accelerating time to market through proven quality and compliance solutions.

© 2023 Sequence, Inc. All rights reserved.