Sequence, Inc.
Sequence Inc. is a biopharmaceutical consulting firm dedicated to accelerating the development and manufacturing of life-changing therapies. With over 20 years of experience, they provide comprehensive services including Commissioning, Qualification, Validation (CQV), and Digital Solutions for biopharmaceutical manufacturing, laboratories, and computerized systems. Their mission is to support clients in bringing safe, effective medicines to market faster through innovative training, digital transformation, and engineering expertise.
Industries
Nr. of Employees
medium (51-250)
Sequence, Inc.
1400 Perimeter Park Drive, Morrisville, NC 27560
Products
Mock biopharmaceutical manufacturing training facility
A fully functional 44,000 sq ft training environment configured with controlled utilities, microbiology and analytical labs, and upstream/downstream manufacturing areas to deliver hands-on CQV and digital solutions training.
Mock biopharmaceutical manufacturing training facility
A fully functional 44,000 sq ft training environment configured with controlled utilities, microbiology and analytical labs, and upstream/downstream manufacturing areas to deliver hands-on CQV and digital solutions training.
Services
Turnkey CQV services for facilities, utilities, process equipment, labs and computerized systems spanning planning, execution, documentation and turnover to demonstrate fitness for intended use.
Design, implement and qualify MES, DCS and manufacturing intelligence systems; deliver digitalization programs including app development for frontline operations and integration with analytics platforms.
Multi-week hands-on training programs delivered in a fully functional mock manufacturing facility covering facilities, utilities, equipment, computerized systems and QC labs; available as standard or customized curricula.
Advisory and implementation services for data integrity programs, CSV/CSA planning, Part 11 considerations, and broader GxP compliance to reduce documentation burden and focus on risk-based controls.
Project lifecycle support from design and procurement through installation, validation and turnover, with cross-functional teams to address technical, quality and regulatory requirements.
Coordination and delivery of laboratory and process equipment calibration services including pipette, lab instruments and process metrology via partnerships.
Turnkey CQV services for facilities, utilities, process equipment, labs and computerized systems spanning planning, execution, documentation and turnover to demonstrate fitness for intended use.
Design, implement and qualify MES, DCS and manufacturing intelligence systems; deliver digitalization programs including app development for frontline operations and integration with analytics platforms.
Multi-week hands-on training programs delivered in a fully functional mock manufacturing facility covering facilities, utilities, equipment, computerized systems and QC labs; available as standard or customized curricula.
Advisory and implementation services for data integrity programs, CSV/CSA planning, Part 11 considerations, and broader GxP compliance to reduce documentation burden and focus on risk-based controls.
Project lifecycle support from design and procurement through installation, validation and turnover, with cross-functional teams to address technical, quality and regulatory requirements.
Coordination and delivery of laboratory and process equipment calibration services including pipette, lab instruments and process metrology via partnerships.
Expertise Areas
- Commissioning, qualification and validation (CQV)
- Computerized system validation and computer software assurance (CSV/CSA)
- Manufacturing execution and process automation
- Digital transformation and manufacturing intelligence
Key Technologies
- Manufacturing Execution Systems (MES)
- Distributed Control Systems (DCS)
- Manufacturing intelligence / analytics platforms
- AI-driven predictive analytics
News & Updates
Join us on October 20th at the Lonnie Poole Golf Club to support Ronald McDonald House of the Triangle. Proceeds benefit families with seriously ill children.
An interview discussing the challenges and solutions in computer system validation (CSV) in the pharmaceutical industry, emphasizing risk-based approaches and innovative tools like VxT.
An article highlighting the importance of data integrity in pharmaceutical labs, especially in the context of accelerated COVID-19 vaccine development.
Details about Sequence's new training facility designed to expedite workforce development in biopharma manufacturing.
The Pfizer Sanford WFI team achieved a major milestone by successfully sampling the largest and most complex WFI system in three years, supporting critical validation milestones.
Join us on October 20th at the Lonnie Poole Golf Club to support Ronald McDonald House of the Triangle. Proceeds benefit families with seriously ill children.
An interview discussing the challenges and solutions in computer system validation (CSV) in the pharmaceutical industry, emphasizing risk-based approaches and innovative tools like VxT.
An article highlighting the importance of data integrity in pharmaceutical labs, especially in the context of accelerated COVID-19 vaccine development.
Details about Sequence's new training facility designed to expedite workforce development in biopharma manufacturing.
The Pfizer Sanford WFI team achieved a major milestone by successfully sampling the largest and most complex WFI system in three years, supporting critical validation milestones.