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Manage and Execute Projects that Have a Lasting Impact

Lean Biologix has expertise in a number of areas to support our Biotech, Gene Therapy, and Pharma manufacturing clients. Our experience can be brought to bear in the following areas:

Protected: What to Ask a Shipping System Vendor?

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Protected: Comparing ASTM D4169-16 to ASTM D4169-22

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Supply Chain Considerations: ISTA Thermal Profiles for Shipper OQ

The purpose of this article is to explain why you may choose an established ISTA profile in lieu of using a custom profile for OQ temperature validation studies. The established ISTA ambient profiles are industry tested and widely accepted globally, whereas custom...

What is Software Development Lifecycle (SDLC) and how does it relate to Computer System Validation

The Software Development Lifecycle (SDLC) is a main component of GMP computer system validation (CSV). In the life sciences industry, regulators audit companies using the gamp 5 guidelines for gamp 5 validation alongside FDA 21 CFR part 11 requirements. Maintaining...

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...

Fast Tracked Gene Therapy Shipping Qualification for BLA

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...

Lab Equipment Inventory Project

One of the largest Biotechnology companies in the world with thousands of laboratory instruments needed to an accurate inventory of their research equipment. The project scope was for all 3 sites worldwide across many departments, system owners and service...

Clinical Drug Packaging and Labeling Operation

The world leader in neurological therapies initiated a plan to bring their clinical packaging from a CMO to an in-house operation. The plan required tripling the current operational capacity. Summary of Engagement Lean Biologix instituted several process improvement...

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