Cell Therapy Manufacturing Partnerships: Sonoma Biotherapeutics’ Jessica Brantley

“Building relationships and transparent communication are key to successful outsourcing in cell therapy manufacturing,” says Jessica Brantley, Senior Manager of External Manufacturing at Sonoma Biotherapeutics.

Jessica Brantley, brings a wealth of experience from her roles at Novartis and a decade at Fujifilm Diosynth before Sonoma Biotherapeutics. Her expertise spans both sides of the outsourcing equation, having worked as a programme manager for a CDMO and now managing external partnerships for a cell therapy innovator.

Sonoma Biotherapeutics is a clinical-stage biotechnology company developing engineered regulatory T cell (Treg) therapies to treat serious autoimmune and inflammatory diseases by restoring balance to the immune system.

In the latest PharmaSource podcast episode, Jessica explains why getting supplier relationship management right is a crucial strategy for driving down costs and improving efficiency in the fast-moving cell therapy space.

Bridging the Gap: Internal Education and External Collaboration

Jessica emphasises the importance of relationship development in the cell therapy manufacturing landscape. “Cell therapy is a newer space within the industry,” she notes. “Helping build those relationships both internally and externally is crucial.”

Her approach involves educatin g internal team members about the contract side, and helping the contract manufacturer to understand their needs.

“We’ve earned trust and more transparency. We’re able to coach them on the operational side, the quality side, and everything else to really drive that collaboration and transparent communication,” Jessica explains.

Navigating the Unique Challenges of Cell Therapy Manufacturing

The transition from large-scale biologics to specialised cell therapies brings unique challenges. Jessica highlights:

• Scheduling complexities with patient treatments
• Coordinating apheresis sites and contract manufacturing partners
• Managing limited patient enrolment due to FDA regulations

“We have to have a very dynamic scheduling with our contract sites,” Jessica states.

Selecting the Right CDMO Partner

When choosing a contract development and manufacturing organisation (CDMO), Jessica considers several factors:

1. CDMO expertise and industry credibility
2. Transparent and open communication
3. Alignment with internal needs and expectations

“If we’re going to do a straightforward tech transfer without process development from the CDMO, then internally, we should work on having detailed process records and providing technical oversight that can support their process,” she advises.

Building Strong Partnerships: Early Engagement is Key

Drawing from her experience on both sides of the outsourcing relationship, Jessica emphasises the importance of early engagement with key stakeholders. She recommends:

• One-on-one meetings with different departments
• Understanding resource modelling and operational constraints
• Discussing challenges and expectations upfront

“Having those discussions upfront really helps with the contract, the timeline, and everything else,” Jessica notes.

Quality Management: A Collaborative Approach

For Jessica, quality management in outsourcing relationships requires:

1. A clear, upfront quality agreement
2. An internal quality group proficient in audits and oversight
3. Integration of quality personnel in operational and technical collaborations

“It’s extremely critical to have your own in-house quality team, especially if you’re working with multiple contract partners,” she emphasises.

Future Trends in Cell and Gene Therapy Manufacturing

Looking ahead, Jessica is excited about the industry’s potential. She predicts increased automation of currently manual processes, with a corresponding growth in electronic documentation and batch records

“I think we’ll see a ton of technological improvements within the next few years,” Jessica forecasts. “Once that takes off, the industry is going to grow tremendously.”

Fostering a Collaborative and Balanced Culture

At Sonoma Biotherapeutics, Jessica highlights the benefits of a diverse leadership team:

• A collaborative and creative environment
• Increased empathy and emotional intelligence in discussions
• Emphasis on work-life balance

“Seeing female representation in leadership positions is very motivating and empowering within our organisation,” Jessica concludes.