Supply Chain Testing

Lean Biologix is the industry leader in supply chain management and testing for Biotech and Gene Therapy manufacturers. We can ensure that your products get from point A to point B, intact while maintaining temperature requirements.

Lean Biologix works with clients to qualify product packaging and shipping systems to support clinical and commercial operations. We provide critical knowledge of industry trends, process improvements and effective strategies to optimize qualification efforts while reducing the issue of “re-inventing the wheel” when developing new assets within a portfolio.

Lean Biologix has a proven track record of developing and executing supply chain qualification programs for domestic and international supply chains while keeping patient safety paramount to our process.

Our staff of experts in this field can provide support to your organization or manage and execute the entire process including:

  • Package design (Drug Substance, Drug Product, Finished Goods)
  • Shipping Qualification Testing – Thermal and distribution
  • Management of product quality attribute testing and container closure
  • Test reports
  • Data verification in support of regulatory submissions (NDA, BLA, MAA)
  • Shipping Qualification Program Development

 

Additional Information:

  • Packaging Development
    • User Requirement Specification
    • Primary, Secondary and Tertiary packaging development and coordination with suppliers
  • Engineering Test Studies – Feasibility with a focus on package robustness
  • Design Qualification – Thermal and distribution testing to evaluate product-specific attributes, packaging and shipping methods
  • Operational Qualification – Lab-based simulated environmental testing to qualify the product, packaging and shipping methods
  • Performance Qualification – Confirmatory real-world shipping studies to evaluate product and shipment logistics

 

Methodology:

We approach our clients with the following methodology:

  • Assessment
    • Collaborate with Internal/External Stakeholders
      • Perform stakeholder interviews to define the current state
      • Identify topics of interest, pain points, and gaps
    • Identify what processes are in place
    • Identify hurdles and challenges present for supply chain functions
    • Prioritize what needs to be addressed (immediate, short, long)
    • Outline Qualification Program including policy and procedure requirements
    • Identify scope change from current state to future
  • Planning
    • Qualification Program Roadmap
      • Supply Chain Mapping
        • Pipeline
        • Internal/External Manufacturing
        • Third-Party Logistics/Storage
        • Logistics Suppliers and Transport Methods
      •  Document technical details pertaining to current/future programs
        • Starting materials
          • Critical Raw Materials
          • Excipients
          • Cell Banks
        • Drug Substance, Drug Product, Finished Good
      • Qualification Requirements
      • Material Planning and Coordination
  • Execution
    • Create/revise existing policies, procedures and work instructions
      • Shipping Qualification vs. Logistics Operations
      • Existing vs. New product platforms including gene therapy
      • Material request process
    • End to end management of each program (DQ, OQ, PQ)
  • Implementation
    • Procedures, Work Instructions, and On-site Training
  • Maintenance
    • Periodic review of supply chain and industry requirements
    • Pivot as required based on expanding pipeline and market access