This startup develops advanced therapy medicinal products (ATMPs) using personalized approaches. They focus on discovering novel therapies with regulatory-compliant and quality-managed systems to improve patient treatment outcomes.
Funding
Funding not disclosed
Founders
Product
Problem
Developing and manufacturing cell and gene therapies (C>) is complex, requiring specialized expertise and adherence to stringent regulatory standards. Biotechs and academic centers often face challenges in scaling up production, ensuring quality, and navigating the regulatory landscape to bring novel Advanced Therapy Medicinal Products (ATMPs) to market.
Solution
Adthera Bio is a digital-first contract development and manufacturing organization (CDMO) focused on cell and gene therapies. They partner with biotechs and academic centers to translate cell therapy ideas into workable medical interventions, ensuring regulatory compliance and quality management throughout the process. Adthera Bio offers process development, manufacturing science and technology (MSAT) services, and quality and regulatory compliance support. Their approach emphasizes optimized quality, high technology, and a "digital first" mindset, leveraging a Quality by Design approach for continuous improvement.
Target Audience
Adthera Bio primarily serves biotech companies and academic centers involved in the development and manufacturing of cell and gene therapies.
Features
- Dedicated team and laboratory for advanced process development, handling pre-GMP and RUO materials.
- GMP simulation suite for cost-efficient process qualification.
- Manufacturing, Science & Technology (MSAT) team to optimize manufacturing processes and ensure regulatory compliance.
- Support for navigating licensing, accreditation, and governance from UK & EU regulatory bodies.
- Digital-first approach to development and manufacturing.