Supply Chain Testing

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

We work with our 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 implement a qualification program to eliminate “re-inventing the wheel” when developing new assets within a portfolio.

Our proven track record of developing and executing supply chain qualification programs for domestic and international supply chains is second to none. Meeting compliance requirements and maintaining patient safety is 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 protocol and report generation as well as approval management
  • Data verification in support of regulatory submissions (NDA, BLA, MAA)
  • Shipping Qualification Program Development

Additional Services:

  • 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

Our Process Methodology:

Assessment

  • Collaborate with internal and external stakeholders to define the current state, identify pain points and gaps

Planning

  • Develop a future state process based on the current state and immediate, short-term, and long-term needs
  • Provide a roadmap for implementation

Execution

  • Develop procedures to execute and document testing (DQ, OQ, and PQ)
  • Create/revise existing policies, procedures, and work instructions

 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