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Project Management for QC Lab Analytical Instrument Qualification

Cell and Gene Therapy

Overview

Beam Therapeutics is a biotechnology company committed to creating a new class of precision genetic medicines based on our proprietary base editing technology, with a vision of providing lifelong cures to patients suffering from serious diseases. The new Beam Tx site in Cambridge is focused on clinical and commercial Cell and Gene Therapy Quality Control (QC). Sequence was selected as the CQV service provider to support initial and long-term activities for the Center of Excellence Quality Control laboratory build out.

Sequence Scope: Project Management for QC Lab Instrument Qualification

The Sequence team was responsible for management and coordination of all vendor installation and qualification activities, managing overall project finances and deliverable completion metrics.
  • The project required a phased approach moving from pre-clinical to stage 2 qualifications that included the Site Validation Master Plan (VMP) for qualification of analytical assets in the QC and MFG spaces, qualification plan development for laboratory automation as well as overall responsibility for site CQV SOP development.
  • Sequence lead the compliance development and testing of GAMP5 Category 5 in-house software appropriate for GMP use and developed Kneat templates for lifecycles documents for 112 analytical assets including VPP, SIA, URS, CS, FDS, FRS, DQ, TM, IOQ, vendor IOQ, PQ, validation summary report, protocol deviations, CR.
Client
Beam Therapeutics
Location
Cambridge, MA
Cell and Gene Therapy
Manufacturing Type

Life Impact

  • Beam Therapeutics was founded by gene editing pioneers with a goal of creating precision genetic medicines with base editing, a technology discovered at Harvard University and the Broad Institute of MIT and Harvard. Since that time, they have further developed and optimized the technology, which has enabled them to build a broad pipeline of investigational precision genetic medicines that have the potential to repair disease-causing point mutations, write in protective genetic variations, or modulate the expression or function of disease causing genes without creating double-stranded cuts in DNA or RNA.
  • Beam is developing therapies for several conditions, with its most advanced programs targeting sickle cell disease (SCD), alpha-1 antitrypsin deficiency (AATD), and certain types of leukemia, while also pursuing treatments for other rare genetic disorders.
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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