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Commissioning, Qualification, Verification (CQV) Services

Drug Product and Drug Substance Manufacturing

Overview

The Lonza Lexington Manufacturing Site consists of multiple modular production suites designed for Drug Product and Drug Substance manufacturing. Additionally, there is a GMP warehouse, Cold Room, Vial Sample Storage, Media/Buffer areas, and QC laboratory space adjacent to the cleanrooms. The Lonza facility expansion supports high-throughput perfusion-based continuous batch manufacturing with a focus on exosome manufacturing platforms targeted for cancer treatment.

Sequence Scope: Equipment Verification

This project involved extensive CQV responsibilities that included development of commissioning and qualification lifecycle for single use technology systems including single use mixers, tube sealers/welders, chromatography skids, incubators, analytical equipment, wave rocker, 500L bioreactor, and perfusion skid.
  • The team was also responsible for establishment of the new site documentation strategy, SOP and work instruction verification, and coordinated performance qualification (PQ) testing for the qualification of a GMP production clean room.
  • Computer System Validation and Data Integrity assessments were required for all relevant GMP process equipment as well as qualification of the GMP Environmental Monitoring System (EMS) systems.
Client
Lonza
Location
Lexington, MA
Drug Product & Drug Substance Manufacturing
Manufacturing Type

Life Impact

  • The Lonza facility in Lexington, MA, focuses on the manufacturing of exosomes, which are being developed as a new type of therapeutic.
  • Exosomes are important in drug manufacturing because they act as natural, non-immunogenic nanocarriers that can effectively deliver a wide range of therapeutic agents, including small molecules, proteins, and nucleic acids. Their key advantages include their ability to cross biological barriers like the blood-brain barrier, superior stability compared to synthetic carriers, and natural targeting to specific cells, which can increase therapeutic efficacy and reduce side effects.
The pharmaceutical and life sciences industries manufacture important products that affect the life and well being of their customers. Equipment to manufacture these products is a vital component of delivering quality, reliable products. The verification of equipment and validation of process ensures the quality of a product by having an independent set of procedures to check that the specifications and requirements for that product are met consistently. The verification and validation documentation is critical in ensuring that equipment is fit for intended use while producing products focused on product quality and patient safety. Regulatory agencies, like the FDA, require equipment verification and process validation prior to achieving licenses to manufacture commercial products.

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Tulip

No Code App Development for Manufacturing Operations

Tulip creates user-friendly and functional apps that improve the productivity of operations, without writing any code. Users can start from scratch or customize an App Template to fit their needs.

Sequence partners with Tulip for implementation and validation of the Tulip platform as well as creation, configuration and validation of Tulip Applications that are hosted on the platform. Our application builds include Electronic Batch Records, Weigh and Dispense, Digital SOPs for training (with embedded videos) and more.

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