VIVEbiotech on quality in advanced therapies

As advanced therapies continue their transition from clinical development to commercial manufacturing, quality has become a critical strategic pillar for ensuring patient safety, regulatory compliance and long-term product success.

In a recent interview with BioPharma BoardRoom as part of its Women of the Future series, Tathiane Castro, Chief Quality Officer at VIVEbiotech, shared her perspective on the evolving role of quality in advanced biopharma and the challenges companies face as increasingly complex therapies move from development to commercial manufacturing.

Throughout the conversation, Castro emphasized that quality should not be viewed solely as a compliance function, but rather as an integral element embedded across product development, manufacturing, technology transfer and supply chain operations from the earliest stages. As products mature, quality and regulatory strategies must evolve alongside the growing understanding of processes, data and patient-related risks.

She also highlighted key challenges associated with scaling innovative biologics and advanced therapies, including achieving process maturity, ensuring product consistency, establishing robust analytical methods and maintaining effective technology transfer between teams and manufacturing sites.

Looking ahead, she underscored the transformative role that technology, data and digitalization are playing in strengthening quality systems and regulatory preparedness. Integrated digital platforms, advanced analytics and enhanced process monitoring can help organizations identify risks earlier, improve traceability and support continuous regulatory readiness across operations.

Beyond quality strategy, she reflected on her experience as a woman in executive leadership. She stressed the importance of fostering inclusive environments where different perspectives are encouraged and where employees feel empowered to raise concerns, challenge assumptions and contribute to better decision-making.

For women aspiring to leadership positions in biopharma, her advice was clear: develop strong technical foundations, seek cross-functional experience, find mentors and embrace greater responsibilities before formal opportunities arise.

As the advanced biopharma industry continues to evolve, VIVEbiotech remains committed to integrating quality, innovation and people-centered leadership to support the development and manufacturing of transformative cell and gene therapies.

Read the full interview on BioPharma BoardRoom.