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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?

by | August 30, 2023 | Supply Chain Testing | 0 Comments

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

by | August 30, 2023 | Supply Chain Testing | 0 Comments

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Supply Chain Considerations: ISTA Thermal Profiles for Shipper OQ

by | June 11, 2023 | Supply Chain Testing | 0 Comments

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

by | February 9, 2023 | IT Project Management | 0 Comments

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...
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Whitepaper: Evaluation of Shipping System Qualification Data

by | January 9, 2023 | Supply Chain Testing | 0 Comments

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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Fast Tracked Gene Therapy Shipping Qualification for BLA

by | August 22, 2022 | Supply Chain Testing | 0 Comments

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...
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Overcoming a Challenging In-Country Distribution Model

by | August 22, 2022 | Supply Chain Testing | 0 Comments

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...
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CDMO Platform Shipping Strategy/Qualification

by | August 5, 2022 | Supply Chain Testing | 0 Comments

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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Lab Equipment Inventory Project

by | July 27, 2022 | Facility and Asset Management | 0 Comments

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...
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Clinical Drug Packaging and Labeling Operation

by | July 27, 2022 | Packaging and Labeling Support | 0 Comments

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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