Projects
Lean Biologix works with biotech industry leaders ensuring they meet strict regulatory filing deadlines and compliance initiatives in supply chain and IT operations.
Automated Computer Software Assurance
Continuous Computer Software Assurance (CCSA) The modern computer software assurance model champions a computer system validation program with effective risk assessment processes. Life science companies have streamlined processes and are focused on meaningful testing...
What to Ask a Shipping System Vendor?
Why choose a pre-qualified shipping system? At some point when designing a supply chain, a system for transporting the product must be developed or selected from available shipping system vendors. The most straightforward and least time intensive option is selecting a...
Comparing ASTM D4169-16 to ASTM D4169-22
What is ASTM D4169 testing? ASTM International developed the standard ASTM D4169, “Standard Practice for Performance Testing of Shipping Containers and Systems,” to test a shipping systems’ ability to withstand typical...
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...
Gene Therapy Shipping Qualification
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. Internal stakeholders needed to tightly manage the timeline required for...
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...
CMMS Parts Forecasting and Kitting
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...
ETOP Process for Therapeutics Manufacturing
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...
CMMS Transition to Electronic System
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...
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.