by Lean Biologix | Jun 11, 2023 | Supply Chain Testing
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...
by Lean Biologix | Jan 9, 2023 | Supply Chain Testing
Click Here for Whitepaper 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...
by Lean Biologix | Aug 22, 2022 | Supply Chain Testing
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...
by Lean Biologix | Aug 22, 2022 | Supply Chain Testing
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...
by Lean Biologix | Aug 5, 2022 | Supply Chain Testing
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...
