CASE STUDY: SANGAMO THERAPEUTICS

Sangamo Therapeutics, a pioneering genomic medicine company seeking to help millions of people who suffer from severe diseases, constructed a new headquarters in Brisbane, CA that included GMP space for Phase 1/2 Cell and Gene Therapy Manufacturing and associated QC labs. TVS was chosen by Sangamo early in the planning and design stages to develop in partnership the appropriate CQV strategies, review the design for testability and regulatory requirements, and integrate the validation activities into the overall project schedule. Sangamo trusted TVS to successfully generate and execute the C&Q test protocols for Utilities, Facilities, Process Equipment, and the support systems for this complicated project. Over 10 highly-skilled TVS professionals supported execution during the peak, and after the capital project was completed in 2022, TVS has continued to support Sangamo for their ongoing CQV needs.

CASE STUDY: CONFIDENTIAL CLIENT

This large global biopharmaceutical producer was the third client in TVS’s history after initiating our first project with them in 1994. For nearly 30 years this client has entrusted TVS with CQV projects annually, and we have successfully helped them navigate product changes, potential plant closures, and their current multi-billion dollar re-investment in a currently operating site where a team as large as 20 is supporting several complex and capital-intensive projects.

CASE STUDY: ADICET BIO

Adicet Bio, a company on a mission to deliver best-in-class gamma delta T cell therapies for patients fighting cancer, selected TVS to collaborate on the development and execution of the full commissioning, qualification, and validation efforts for their phase 1/2 Cell and Gene Therapy facility in Redwood City. Despite being a retrofit of an existing space and the many unique challenges this created in the execution of their C&Q efforts, the project was completed under budget. The TVS team also helped mitigate several pandemic-caused project delays by crafting creative solutions to overcome supply chain issues while maintaining our ability to meet the company’s goals.

TESTIMONIALS

“I have a long and successful history with TVS, including partnering on various projects ranging from CQV of a new greenfield facility to staff augmentation needs. With over 25 years of experience working with them, I have found that TVS consistently delivers on their commitments, creates solutions based on our needs, and brings incredible depth and expertise to their work. At the same time, their seasoned staff are always looking for ways to improve/expand their knowledge to better fit/align with customer needs. TVS has truly been our partner, and you can count on them to follow existing proven protocol and/or provide alternative approaches based on their experience to ensure the ‘c’ in cGMP is maintained.”

– Shawn Phillips, Principal Validation Engineer, Genentech/Roche

“In my role at a cancer-focused biotechnology company, it was critical that we worked with a compliance partner that consistently went above and beyond, and the highly effective and knowledgeable TVS project team was nothing short of exceptional. From the beginning they were committed to our success, and they did so in part by always maintaining an acute awareness of our timeline and budgetary requirements. This enabled them to developed customized solutions that fit our needs, and it was all done with an expert-level understanding of FDA and EU compliance requirements paired with impressive and impactful technical expertise.”

– Former Client (Confidential)

“I’ve had the pleasure of working with TVS many times over the past 15 years or so in different capacities and they always show a commitment to understanding the problem, using the right resources for the situation, and providing rational solutions. Through this, TVS has become one of my most trusted partners, from ‘big though’ concepts to the basic but extremely necessary details of project execution. They always adapt, grow through individual project experience, and hire team members who integrate quickly and easily because they have the right skills and emotional intelligence. I’m looking forward to our next project together.”

– Sean McKillop, VP Engineering & Facilities, SCiFi Foods

“During my first experience working with the TVS team, I was immediately impressed with their outstanding expertise and commitment to performing all aspects of qualification activities for a large biopharmaceutical project. TVS always acted in our best interests as the client, and they supported us as a valued partner by using their expert knowledge throughout all project phases. Even though we were under extreme time and cost constraints, TVS made one of our most important projects a success.”

– Current Client (Confidential)