Optimize Next-Gen Manufacturing

Setting the manufacturing standard for cell and gene therapy success

Start with the team that led the industrialization of the most notable FDA-approved advanced therapies—and then created the world’s largest cell and gene therapy manufacturing footprint. Precision helps cell and gene therapy trials achieve operational excellence, accelerating speed to market for life-changing therapies.

20+ facility builds totaling more than $1 Billion

Technical Operations Strategy

Advanced therapies face vast manufacturing bottlenecks. We alleviate them, providing an experienced team to define your manufacturing strategy and develop your technical operations—then execute that strategy with confidence.

Advanced therapy manufacturing begins with the pipeline. Through thorough due diligence and expert analysis, we define the optimal manufacturing strategy to mobilize and industrialize your pipeline.

  • Due diligence
  • Asset evaluation & pipeline analysis
  • Industry trend analysis
  • Manufacturing platform & technology analysis
  • Manufacturing scale-up planning
We have helped over 20+ advanced therapy organizations—including startups, established companies, academic centers of excellence, CMOs/CDMOs and financial institutions—with the critical decision of internal versus external manufacturing based on in-depth value analysis.

  • Market intelligence
  • Growth strategy
  • Qualitative & quantitative assessment
  • Capital and operating budget analysis
  • CMO/CDMO evaluation, selection and management
  • Site region evaluation
  • Site selection & due diligence
  • Facility build startup & operations
Regulatory approval of advanced therapies hinges on strict compliance to clinical and commercial manufacturing cGMP regulations. We have long experience in developing the policies, right-sizing quality management systems, then executing to ensure success.

  • Facility infrastructure & startup
  • cGMP programs, policies & procedures
  • Quality management systems & program implementation
  • Engineering & validation program development
  • Training & development
  • Finance & project controls
  • Talent Sourcing & HR
  • Marketing

Cell and gene therapy technical operations are complex. We often lead tech operations development from organizational charts and hiring plans to finance and project control, project charters and detailed execution plans.

  • Organizational charts
  • Policies & procedures
  • Standard operating procedures (SOPs)
  • Project plans
  • Scope, schedule & budget
  • FTE backfill (senior executive to engineering roles)

Manufacturing Execution

Your cell and gene therapies require highly specialized manufacturing and technical operations. So, we developed an Advanced Therapy Manufacturing Playbook, which has been road-tested by the leading advanced therapy organizations and regulatory agencies.

We leverage unparalleled experience in cell and gene therapy manufacturing to support every facet of a building project, backfilling critical project management, construction, technical, and engineering roles to ensure your success.

  • Project and program management
  • Facility design
  • Cleanroom design
  • CRO, CMO/CDMO, selection & management
  • Vendor and equipment selection, procurement & management
  • Operating infrastructure support
  • Scope, schedule & budget management
  • FTE backfill (senior executive to engineering roles)
As a versatile system integrator, we provide specialized engineering services for advanced therapy facilities, as well as equipment and technology dedicated to these therapies.

  • Preliminary, conceptual & detailed facility design (greenfield & brownfield)
  • URS / FS / DS documentation
  • Vendor and equipment selection, procurement & management
  • Change control ownership
  • Automation and integration
  • Part-11 compliance
  • Facility utilities: mechanical, electrical & plumbing
  • System owner & process engineering
We understand the specific requirements for GMP, GLP, and GCP systems and various FDA, EMA, and other global regulations for advanced therapies, as we have led the commercialization of notable cell and gene therapies—and we cover the full gamut of validation services.

  • Traditional commissioning & qualification
  • Validation program development
  • Validation program maintenance
  • Process, computer, cleaning, steaming & laboratory validation
The policies and procedures we develop for both ISO certification and global GMP compliance reflect our deep experience in advanced therapies; we clearly understand your needs from data integrity to compliance remediation.

  • Policies & procedures development
  • Quality management systems
  • Supplier quality management program implementation
  • Data integrity & Part 11 compliance
  • Auditing services
  • CMO/CDMO selection and management, quality agreements, person in plant
  • Quality risk assessments
  • NC & CAPA program development
  • Regulatory strategy & submissions
  • Audit preparation & support
  • Compliance remediation
Our operations services for cell and gene therapies encompass the complete asset management lifecycle, starting with program and department creation. We can lead your resource modeling and the creation of policies and procedures, schedules, budgets, and operations to maximize production uptime.

  • Program & department creation
  • Staffing & group identification
  • Policies, procedures & training materials
  • Asset management strategy
  • EAM & CMMS selection & optimization
  • Facility gap assessments & optimization
  • Quality by Design principles
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Learn how Precision ADVANCE can optimize next-gen manufacturing