API Innovation Center
APIIC is a nonprofit organization dedicated to strengthening national health security and building a resilient pharmaceutical supply chain in the U.S. by uniting government, industry, and academia to advance technology and optimize manufacturing facilities. Their mission is to produce more active pharmaceutical ingredients (APIs) domestically, reducing reliance on foreign sources, and ensuring reliable access to essential medicines through innovative manufacturing technologies and strategic collaborations.
Industries
Nr. of Employees
small (1-50)
API Innovation Center
Products
Domestic lomustine API production project
Project to develop and produce a domestically manufactured API for lomustine using continuous manufacturing approaches to address availability for glioblastoma treatment.
Research & development laboratory (university collaboration)
State-of-the-art R&D laboratory established in collaboration with a university to advance continuous-flow routes and support early-stage process development for APIs.
Domestic lomustine API production project
Project to develop and produce a domestically manufactured API for lomustine using continuous manufacturing approaches to address availability for glioblastoma treatment.
Research & development laboratory (university collaboration)
State-of-the-art R&D laboratory established in collaboration with a university to advance continuous-flow routes and support early-stage process development for APIs.
Services
Laboratory and pilot-scale development of synthetic routes and processes for APIs, including transfer to manufacturing scale.
Development, qualification and GMP transfer of stability-indicating and routine analytical methods for APIs and intermediates.
Support for GMP process transfers, batch record preparation, validation activities and preparation of regulatory documentation such as DMFs.
Comprehensive project management including scope definition, scheduling, budget oversight, vendor coordination and stakeholder communication for API and finished drug development.
Assessment and program design to strengthen domestic API supply chains, plus development of policy recommendations and white papers to inform stakeholders and policymakers.
Creation and management of collaborations among academic, government and industry partners to advance API manufacturing projects and regional initiatives.
Laboratory and pilot-scale development of synthetic routes and processes for APIs, including transfer to manufacturing scale.
Development, qualification and GMP transfer of stability-indicating and routine analytical methods for APIs and intermediates.
Support for GMP process transfers, batch record preparation, validation activities and preparation of regulatory documentation such as DMFs.
Comprehensive project management including scope definition, scheduling, budget oversight, vendor coordination and stakeholder communication for API and finished drug development.
Assessment and program design to strengthen domestic API supply chains, plus development of policy recommendations and white papers to inform stakeholders and policymakers.
Creation and management of collaborations among academic, government and industry partners to advance API manufacturing projects and regional initiatives.
Expertise Areas
- API manufacturing reshoring
- Continuous flow and advanced manufacturing commercialization
- Process development and scale-up
- Analytical method development and qualification
Key Technologies
- Continuous flow chemistry
- Continuous manufacturing (flow reactors)
- Process analytical technology (PAT)
- Liquid chromatography (HPLC/UPLC)
News & Updates
The APIIC was awarded a $14 million grant by the U.S. Department of Health and Human Services to bolster domestic pharmaceutical manufacturing.
The APIIC participated in a roundtable discussion in Washington, D.C., addressing the ongoing drug shortage problem in the U.S.
The APIIC was highlighted on Nine PBS for its work in relocating critical drug manufacturing back to the U.S.
The APIIC is working to bolster domestic pharmaceutical manufacturing and reduce reliance on foreign sources, strengthening national health security.
A white paper emphasizing the importance of a collaborative approach to enhance the resilience and security of the U.S. pharmaceutical supply chain.
The APIIC and UMSL unveiled a state-of-the-art research and development lab to advance new continuous flow routes for API production.
The APIIC was awarded a $14 million grant by the U.S. Department of Health and Human Services to bolster domestic pharmaceutical manufacturing.
The APIIC participated in a roundtable discussion in Washington, D.C., addressing the ongoing drug shortage problem in the U.S.
The APIIC was highlighted on Nine PBS for its work in relocating critical drug manufacturing back to the U.S.
The APIIC is working to bolster domestic pharmaceutical manufacturing and reduce reliance on foreign sources, strengthening national health security.
A white paper emphasizing the importance of a collaborative approach to enhance the resilience and security of the U.S. pharmaceutical supply chain.
The APIIC and UMSL unveiled a state-of-the-art research and development lab to advance new continuous flow routes for API production.