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Capabilities

Rise Therapeutics is a clinical-stage immunotherapy company developing first-in-class oral immune therapies for the treatment of autoimmune diseases and cancer. With a fully integrated infrastructure, our multidisciplinary team harnesses cutting-edge science to bring innovative, precision-engineered immunotherapies from discovery to patients.

INFRASTRUCTURE

Clinical GMP Manufacturing

Rise Therapeutics integrates regulatory expertise with clinical development and in-house GMP manufacturing, ensuring seamless translation from discovery to patient-ready immunotherapies with the highest quality standards.
We have built a fully integrated, in-house GMP manufacturing facility to support seamless translation from discovery to patient-ready immunotherapies. Given the highly proprietary and innovative nature of our therapies, we designed a state-of-the-art GMP operation capable of manufacturing both drug substance and drug product under the highest regulatory and quality standards.
Our GMP manufacturing facility features:

  • Clean space isolator systems and modular GMP clean rooms to ensure processing at various production scales.

  • High-throughput automatic encapsulation for drug product manufacturing, followed by packaging, labeling, and distribution to clinical sites nationwide.

  • Advanced analytical systems for validated product release, characterization, and stability assessments.

  • Compliance with 21 CFR Part 11 standards, ensuring data integrity and regulatory adherence.



CLINICAL TRANSLATION

Product Development

Backed by robust preclinical data, Rise Therapeutics’ Oral Immune BioModulators are advancing through clinical trials across multiple indications, offering patients a safe, first-in-class approach to correcting the underlying immune dysregulations that cause their disease.
By integrating our clinical and regulatory operations, we streamline the development, production, and human clinical validation of our first-in-class Oral Immune BioModulators. This fully integrated product development infrastructure provides end-to-end control to accelerate clinical translation, ensure uncompromising quality, and efficiently bring innovative immunotherapies to patients.