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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:

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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CMMS Parts Forecasting and Kitting

by | July 19, 2022 | IT Project Management | 0 Comments

A Global Fortune 500 life science organization desired to streamline their Cambridge, MA site CMMS parts ordering process allowing managers to level set periodic ordering costs. Lean Biologix developed and implemented an integrated PM parts forecasting and kitting...
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ETOP Process for Therapeutics Manufacturing

by | July 19, 2022 | Facility and Asset Management, Project Management | 0 Comments

The top RNAi Manufacturer built a new manufacturing site to support their new products. The site construction was underway without an established plan to collect and organize all of the construction, testing and commissioning documents. The goal was to generate an...
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CMMS Transition to Electronic System

by | July 19, 2022 | Facility and Asset Management, IT Project Management | 0 Comments

A world leading Biopham manufacturer decided to transition their manufacturing work orders from paper to an electronic process during an upgrade of their global Computerized Maintenance Management system (CMMS). This was a huge undertaking given the amount of assets...
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