SUMMARY
A start-up biotechnology corporation manufacturing cell, gene, and immunological therapies for treatment of cancer needed the consulting expertise of an integrated team with deep knowledge of life science start-ups and an understanding executive leadership that could hit the ground running.
CHALLENGE
The main challenge was that the company did not have the internal resources to reach their goals. Solutions that were efficient and complied with all regulatory requirements needed to be put in place quickly and without costly mistakes.
They needed to address complex global regulatory, compliance, and supply chain challenges. In addition, they also needed to be able to plan for supportive quality systems, quality in manufacturing and supply chain systems that insured integrity of their product and systems.
SOLUTION
The Windshire Group and Court Square Group quickly and expertly guided the company through a range of solutions that effectively addressed their needs in processing, manufacturing, quality, IT integration, and supply chain. The Windshire Group, LLC has been working with the client for two years from business concept through fund raising from Series A to Series B.
To best meet client and project needs, parallel initiatives were launched in multiple areas, including:
- Participated on the executive leadership team
- Assessed GMP requirements for CAR-T cell therapy
- Generated GMP SOPs
- Assisted with conceptual design of their facility for early clinical manufacturing
- Performed risk assessments around their facility and their processes
- Evaluated and assessed material waste, personnel, and process flows within the facility
- Provided strategic insights into the business model for a CDMO
- Initiated set up of their quality system
COLLABORATION
The client was struggling with organizing work, documentation, and work-flow management, delaying project progress. The Windshire Group’s partnership with Court Square Group offered a swift IT infrastructure and RegDocs365 solution that quickly helped their team organize and communicate effectively across continents.
RESULTS
The impact was immediate. Collaboration and workflows increased dramatically. Documentation is now organized and easy to find, and housed in a structure that enables the initial, basic quality system. Signature signoffs were no longer lengthy ordeals. Documentation and quality processes are now housed in a compliant environment ensuring data integrity.
ABOUT THE WINDSHIRE GROUP
The Windshire Group (windshire.com) is a global consultancy that provides comprehensive CMC and management services to pharmaceutical, cell therapy, and medical device companies and industry investors. info@winshire.com
ABOUT COURT SQUARE GROUP
Court Square Group is a leading managed services technology company dedicated to empowering those who change lives. Our Audit Ready, Compliant Cloud™ (ARCC) infrastructure provides Life Science companies with the highest level of data integrity from pre-clinical to clinical and regulatory approval through manufacturing. We manage the 21 CFR Part 11 validated infrastructure so you can focus on secure Clinical Collaboration & Content Management.