Making the uncurable curable is the aim of the cell and gene therapy sub-field of the pharmaceutical industry. It is the next frontier of healthcare that will revolutionize treatments, potentially cure incurable diseases, and transform patient lives completely.
One of the trailblazers of this still-developing discipline is Dr. Giuliana Vallanti, Head of Development and Global Head of R&D for Cell and Gene Therapy at AGC Biologics.
Dr. Giuliana is an expert in the development and industrialization of T- and hematopoietic cell transduction processes with lentiviral and retroviral vectors. She has worked on the development of GMP processes for large-scale vector production and purification for lentivirus, retrovirus and AAV. She is designing processes that help scale and commercialize cell and gene therapies, making them available to the general population.
AGC Biologics offers deep industry expertise and customizable services and strives to provide innovative solutions to its customers, helping them reach their goals and accelerate their projects at our cGMP-compliant facilities in the US, Europe, and Japan. It also helps facilitate approval and manage spending during the product lifecycle.
In an exclusive interview with Insights Success, Dr. Giuliana Vallanti shares developments in the field of Cell and Gene Therapy and her challenges in pioneering life-changing work.
Below are the highlights of the interview:
Briefly describe your professional journey up until now.
My current role is the Head of Development and Global Head of Cell and Gene Therapy R&D at AGC Biologics, a leading global Contract Development and Manufacturing Organization (CDMO). I am a biologist with a Ph.D. in Cell and Gene and have worked in this amazing field since the beginning of my career.
My main responsibility is to develop processes and analytical testing for viral vector production and genetically modified cells. My team develops manufacturing processes for our customers, as well as new platforms and technologies aimed at improving cell and gene therapy production in the future.
What challenges did you face along the way?
The main challenge is that the field is still very young and immature, so standards and best practices are finite. However, this is also the most interesting part of my job. We are constantly searching for new solutions and techniques to ensure we produce a high-quality, safe, and functional product. The beauty of cell and gene therapies is their curative nature to very devastating diseases. But since the therapy is made up of the patient’s own cells, finding a way to genetically “fix” them remains a significant challenge, and my job entails just that – achieving a way to do it.
The core team at our AGC Biologics Milan site has been working through these challenges for more than 20 years, so while this industry is young, my teammates have a broad depth of expertise in this space. The site was the first approved in Europe for GMP manufacturing of cell and gene products, and we have developed three commercial products for patients in need.
What significant impact have you brought to the life science industry?
Cell and gene is often considered as the new frontier of personalized medicine, and I am very proud to be part of this field. My team and I work hard every day to ensure these treatments translate from the researcher’s bench to the patient’s bedside. Thanks to what we do, in collaboration with our customers and partners, we have saved more than 150 infants affected by devastating lethal rare diseases who are now living a normal life (ex: immunodeficiencies, lysosomal storage diseases, hemoglobin disorders). As pioneers in this field, the team at our AGC Biologics Milan site helped bring to market the first two ex-vivo gene therapies approved worldwide.
Tell us about AGC Biologics and its foundation pillar.
AGC Biologics is a global CDMO providing pharmaceutical development and manufacturing services for protein-based biologics and cell and gene therapies. We specialize in the following modalities and substances, mammalian and microbial-based therapeutic proteins, recombinant DNA, plasmid DNA (pDNA), Messenger RNA (mRNA), viral vectors, and genetically engineered cells.
Our mission is to work side by side with our customers in order to improve patient’s lives by bringing new biopharmaceuticals to market. AGC biologics values are Innovation & Operational Excellence, Diversity, Environment, and Integrity.
How does AGC Biologics promote workforce flexibility, and what is your role in it?
Our teams are committed to high quality and execution standards. Every person knows that by meeting our customers’ needs, we meet the needs of patients, improving – and often saving – lives. Our customers entrust us with this enormous responsibility, and we could not make it happen without our people. By putting our people first, we help our teams deliver for our customers and their patients.
AGC Biologics promotes a healthy work-life balance because we believe that by supporting our employees’ well-being, they come to work focused, efficient, and productive. With most of our activities carried out in labs with very sophisticated equipment, we are often required to work on-site. Still, we have a structure that allows for some remote and hybrid working across the entire organization.
What is your take on technology’s importance, and how are you leveraging it?
Technologies evolve very rapidly and, particularly in the Cell and Gene field, we need not only to remain up to date on new ones, but we also strive to design and define new flows “out of the blue” by adapting technologies designed for other scopes and applications. However, when possible, we do try to leverage practical solutions and practices from other fields rather than reinventing the wheel every time.
What will be the next significant change in the life science industry, and how are you preparing for it?
Undoubtedly, after classical chemistry followed by biotechnology, cell and gene therapy is the future of medicine. The field is still in its embryonic phase, and everything we do remains very manual. The challenge is to move this field into a real industry with large-scale, automated, and reliable systems and technology that will make these therapies more affordable, robust, and safe. To continue leading the way, as we have done for the last 25 years, we are investing significantly in technical innovation, capacity, and scalability.
What are your goals in the upcoming future?
My goal is to do as much as I can to work towards making Cell and Gene Therapy more accessible to a wider population. By developing newer and better processes, these therapies are manufactured safely, timely, and affordably, thus ensuring their sustainability. Personally, I’m very happy to continue my role as a mentor to young scientists who work with me by transferring my passion for the subject and technical skills that are a fundamental requirement in this field.
What advice would you like to give the next generation of aspiring business leaders?
My main suggestion is to follow your passions and invest time and energy in education and learning at the beginning of your career. Be open-minded. You can learn from many of those around you, not only from your manager. Move out of your comfort zone as much as possible, even though it may be challenging at first – this is the only way to grow. Choose a job that brings a smile to your face when you wake up in the morning. This makes a huge difference!
