supply chain model with bus, plane, earth and checkmark photo

Supply Chain Testing Services

 

Lean Biologix is an industry leading consulting firm who has a strong focus on supply chain management and testing for life science manufacturers. We work to ensure temperature control and integrity of your product is maintained while being shipped within your supply chain.

We work with our clients to qualify product packaging and shipping systems to support clinical and commercial operations.

We leverage our knowledge of regulatory requirements, industry standards and best practices to support all aspects of shipping qualification for our clients. We have a standardized process for managing shipping qualification programs that has been proven successful with regulatory agencies and eliminates “re-inventing the wheel” when developing or qualifying additional assets within a client’s 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 supplemental support to your organization or manage and execute the entire process end to end.

Package Design (Drug Substance, Drug Product, Finished Goods)

Our team of qualified engineers utilizes over 60 years of cumulative experience to develop product packaging that is manufacturable and robust.  Our designs are built considering automation and are streamlined to support implementation on all packaging lines.

Shipping Qualification Testing – Thermal and distribution

Shipping qualification is one of the last steps before a regulatory filing and is often overlooked.  Our team of industry experts have assisted in over 20 successful commercial launches.   The Lean Biologix team has experience owning the entire process from the scope and planning phase through testing and implementation. We also support all post-implementation activities including inspections, audits, and periodic reviews.

Product Quality Attribute Testing (PQA) & Container Closure Integrity Testing (CCIT)

Over the course of its route shipments are exposed to hazardous conditions, these conditions create risks that require mitigation. One of these risk mitigations is performance of CCIT (Container Closure Integrity Testing) commonly referred to as leak detection. CCIT is a non-destructive packaging inspection system to ensure that the aseptic barrier against potential contaminants is maintained. Secondarily, there is PQA (Product Quality Attribute) testing which is a panel of testing to be run on the transported product post-shipment to ensure that the product has maintained its properties and function. Lean Biologix uses proven experience and best practices to ensure shipping risks are kept to a minimum. 

Test Protocol, Report Generation, and Approval Management

If it was not documented it didn’t happen according to the FDA.  Our team of qualified experts owns and generates the documentation required to be presented during regulatory filings and audits.  Our industry experience with audit responses and audit readiness ensures a robust technical package is created that will satisfy any auditor or regulatory agency.

Audit and Regulatory Support for Regulatory Submissions (NDA, BLA, MAA)

Shipping qualification is a critical topic during regulatory review. Lean Biologix assists with data verification, filing documentation support, audit readiness, and audit responses.  Our engineers consistently drive successful audit responses.  Use our experience to alleviate the audit stress.

Shipping Qualification Program Development

Shipping qualification is a complex process with ever changing regulatory requirements.  Developing a robust audit-ready process can be a daunting task.  Lean Biologix has a proven track record of creating compliant, easy to follow, and resilient processes.  Our engineers have the expertise to  generate, train, and implement SOPs and processes across a broad spectrum of Shipping Qualification related topics.  The processes developed can be maintained with minimal operational cost.

Engineering Test Studies – Feasibility with a focus on package robustness

The sourcing and development of packaging can be a difficult and time consuming task. Our strategic partnerships with certified test labs and trained personnel helps relieve the burden of packaging design assessments for our clients.  Lean Biologix runs in quick succession a variety of stress tests aimed to assess packaging robustness, label adhesion, temperature control, responses to low pressure environments, and / or storage studies.  These studies are instrumental in the completion of a smooth qualification process.

Design Qualification – Thermal and Distribution testing to evaluate product-specific attributes packaging, and shipping methods.

  • In design testing speed and compliance are key.  Design testing is to be performed once a keen understanding of conditions, transport, and route is acquired.
  • It is important to simulate the worst case scenario for the packaged product along its designated route. When performing design testing thermal and distribution testing hazards will be tested.  Lean Biologix’s team of industry experts are uniquely qualified to quickly assess and test client designs and get to the bottom of any design concerns.

Operational Qualification – Lab-based simulated environmental testing to qualify the product packaging and shipping methods

  • Thermal: Thermal operational qualification is a study we perform in minimum and maximum. The loads are typically tested to bracket the shipping system’s ability to maintain temperature control for a minimum required duration. Our team of engineers ensure testing is done right the first time, every time. 
  • Distribution: Distribution testing will expose minimum and maximum product payloads and packaging to simulated hazards that mimic the worst-case shipping hazards. This is both a regulatory requirement and risk mitigation measure to reduce product loss during transit. 

Our team of industry experts have led these studies for over 20 launched projects, we bring the technical experience and knowledge to make sure distribution OQ runs smoothly and efficiently.

Performance Qualification – Confirmatory real-world shipping studies to evaluate product and shipment logistics

  • Performance Qualifications (PQs) are used as confirmatory studies or as additional data collection tools. These studies are designed to track real-world shipments across the active supply chain or worst case expected supply chain conditions. 

PQs assess thermal and physical performance during the outbound/inbound shipping process. With increased regulatory scrutiny on real-world data prior to launch, PQs are a critical compliance activity to ensure product quality. Our knowledge and experience ensure that qualifications are completed on time and are robust enough to defend against regulatory scrutiny.

Whitepaper: Evaluation of Shipping System Qualification Data

The Lean Process Learn and apply industry best practices within your qualification processes to evaluate qualification data provided by thermal shipping system manufacturers and vendors. Leveraging pre-existing qualification packages is a tremendous time and resource...

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A global biotechnology company working toward regulatory approval of a gene therapy treatment was required to perform shipping validation to support review and approval in the US market. As the primary indication was targeted for fatal neuromuscular genetic disease...

Overcoming a Challenging In-Country Distribution Model

A leading fortune 500 company headquartered in Cambridge, MA was planning to launch a number of biological products into new markets for the first time. Product specific shipping qualification was performed and qualified shipping containers were in use for domestic...

CDMO Platform Shipping Strategy/Qualification

A leading cell and gene therapy CDMO located in Cambridge, MA desired to qualify and implement platform shipping systems that could maintain their product requirements and regulatory compliance.   Challenges Aggressive timeline to complete qualification and...

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