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How Minaris is Tackling the Scalability Challenge in Cell and Gene Therapy: A Conversation with CEO, Dr. Hiroto Bando
Minaris Regenerative Medicine is innovating cell and gene therapy manufacturing with automation, global expansion, and a patient-centric approach
Manufacturing bottlenecks and scalability hurdles continue to challenge the cell and gene therapy industry, slowing the journey of innovative treatments from lab to patient. High costs, labor-intensive processes, and supply chain constraints make large-scale production daunting, while ensuring consistency and quality adds another layer of complexity. These issues, coupled with the need for cost-effective solutions, drive urgent calls for innovation in the field.
Here, we discuss how Minaris Regenerative Medicine aims to enhance manufacturing efficiency through automation technology and closed systems. Dr. Hiroto Bando, a leading expert in cell and gene therapy and CEO of Minaris, highlights the transformative potential of various cell and gene therapies, emphasizing the importance of striking a balance between cost reduction and target indications. Additionally, he sheds light on Minaris’ global expansion initiatives, with plans to establish research and production centers in strategic locations such as the U.S. and Europe, while also exploring opportunities in gene therapy through joint ventures and proprietary product development.
Minaris Regenerative Medicine is focusing on enhancing manufacturing efficiency through automation, global expansion, and a patient-centric approach to tackle scalability and cost challenges in cell and gene therapy.
Enhancing Manufacturing Efficiency: Automation Technology and Closed Systems for Scalability and Cost-effectiveness
Minaris Regenerative Medicine plays a pivotal role in advancing cell and gene therapies while addressing production and economic challenges. With over 20 years of expertise, the CDMO company specializes in developing innovative clinical and commercial manufacturing solutions for these groundbreaking treatments.
Dr. Hiroto Bando, CEO of Minaris, discussed the evolving cell therapy landscape and its vast potential in treating complex conditions. He highlighted the pivotal role of CAR T-cell therapy in oncology, noting, “The CAR T field is experiencing significant growth, with a focus on reducing production and manufacturing costs for next-generation products.”
CAR T-cell therapy, a groundbreaking treatment using a patient’s immune cells to fight cancer, faces significant production challenges. Dr. Bando emphasized the importance of scalability and cost-effectiveness in overcoming these hurdles. He added that identifying emerging target areas is crucial for industry progress. Also, Bando shared that automation technologies and closed systems are key to improving the efficiency and consistency of cell and gene therapy manufacturing. These innovations help reduce human error, increase speed, and ensure sterility, making large-scale production more feasible and cost-effective. As Dr. Bando states, “Automation technologies and closed systems are crucial here, since we are trying to streamline the process.” These approaches aim to address conditions where personalized treatments are financially unsustainable.
Key Considerations in Cell Therapy: Cost Reductions and Target Indications
Minaris Regenerative Medicine is at the forefront of advancing cell therapy, focusing on stem cell research and genetic modification to revolutionize treatment options. Dr. Hiroto Bando emphasized the immense potential of regenerative cells, stating, “By harnessing the regenerative capabilities of cells to promote healing and improve patient outcomes, the practical implications of this are immense, with market considerations exploding.”
For one, induced pluripotent stem (IPS) cell therapies are a promising area, despite challenges with immune reactions. Bando highlighted the importance of overcoming these obstacles, particularly in autologous treatments. “In such instances, when immunoreactions occur with current IPS cells, it becomes challenging to prolong the duration needed to ensure the therapy remains autologous. Recently, I’ve noticed that some companies are shifting their focus towards IPS-derived products, particularly those centered around HLA renewal or the development of universal IPS cells that offer potential solutions to immunoreaction issues.”
While IPS cells show potential for addressing genetic deficiencies, Dr. Bando noted that the field needs time to mature. “I believe it takes about 10 years to effectively launch or expand a business. Initially, focusing on autologous therapies is crucial. However, the next step involves developing universal IPS-derived products like T-cell, NK-cell, or gamma-delta-cell therapies.”
Dr. Bando also touched on advancements in CAR T-cell therapy, noting significant progress in treating blood cancers but identifying ongoing challenges with solid tumors. “Basically, we hope to identify specific targets and create a more detailed solution,” he said. As Minaris continues to innovate, these developments aim to overcome the economic and technical barriers shaping the future of cell therapy.
Directing Asia’s Focus Towards the Established U.S. Market; Recognizing the Promising Potential of the EU
The limitations of cost-saving measures in cell therapy compared to traditional small molecule drugs are clear. Cell therapy may not replace standard care but offers a significant opportunity for patients who cannot be treated conventionally. However, pricing challenges are more pronounced in Europe than in the U.S. and Japan. In Europe, pricing and reimbursement issues are major obstacles, while the U.S. benefits from a more flexible pricing system. Dr. Bando states, “The U.S. market is of paramount importance, and Asian companies, including those from Japan, Taiwan, and China, should concentrate on expanding their product development globally if they possess strong potential.”
Balancing price, efficacy, and safety is crucial for CDMOs like Minaris, especially considering the varying eligibility and pricing factors for cell therapy across different age groups. Pricing strategies often impact business operations. For example, in sickle cell disease, differences in reimbursement between Europe and the U.S. highlight the need to balance price with efficacy and safety. “Determining the appropriate price point requires careful consideration of patient demographics and disease rarity. While cell therapy holds immense promise, ensuring accessibility and affordability is the most important part.” This reflects ongoing debates about pricing transparency and equitable access to innovative therapies, influencing industry practices and regulatory policies.
Dr. Bando stresses the importance of a patient-centric approach in product development. Drawing from his experience at Takeda, he highlights the need to address unmet medical needs, even in smaller patient populations. “At Takeda, we prioritized being patient-centric. This means always considering the patient’s needs, especially when there are few affected. If there’s no existing treatment, it’s important to find a solution and provide a treatment option for those patients.”
Minaris Eyes Global Expansion Initiatives to Drive Market Growth and Product Development, Emphasizing GMP Importance
Minaris plans to expand its global presence by setting up small-scale GMP facilities. These will be in strategic areas of interest. The company is establishing research and production centers in the U.S. and Europe. Future locations will be based on client needs and market demand. Potential sites include the U.S. west or east coast and countries like Italy, the UK, Germany, and France. Key factors include technological expertise, niche products, and logistical advantages.
“Minaris is looking toward Europe. The UK has a strong tech center, Italy offers niche products, and France has good logistics. The decision is based on customer needs and market demands. But, GMP is the first point of the supply chain, and its strength is vital.”
Minaris is currently focusing on cell therapy services. It is also exploring joint ventures with customers or venture companies in gene therapy. These ventures may involve creating new entities to develop gene therapy products. While standardization is important in cell therapy, gene therapy is more advanced. Minaris is considering dedicated companies for gene therapy development. Although most gene therapy products are outsourced now, the long-term goal is to develop proprietary products. However, customers prefer keeping their gene therapy technology in-house, unlike the service demand in cell therapy.
“In cell therapy, we focus on services. In gene therapy, about 30% of products are outsourced. But we are considering joint ventures and may shift to developing our own products in the future.”
GeneOnline CEO, Thomas Huang (left) interviewed Minaris Regenerative Medicine CEO, Dr. Hiroto Bando (right), and discussed the role of Minaris in the field of cell and gene therapy.
