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Small Molecule APIs
Abiozen stands at the forefront of small molecule API manufacturing, offering high-purity actives that form the backbone of numerous therapeutic applications. Our advanced infrastructure and expertise ensure compliance, quality, and scalability across every phase of production.
Precision Synthesis & High Yields
Our multi-step organic synthesis processes incorporate catalytic reactions and chiral resolution techniques to achieve superior stereochemical purity. Optimized for complex molecular structures, our platforms deliver yields consistently exceeding 85%, reducing waste and enhancing sustainability.
Process Control & Batch Consistency
We implement Design of Experiments (DoE) and Quality by Design (QbD) principles to ensure consistency across every batch. Real-time monitoring and in-process controls (IPC) maintain reliability and performance throughout the production lifecycle.
Advanced Purification & Sterility Assurance
Guided by global standards and inspired by Curia Global’s best practices, we employ HPLC and SFC to surpass pharmacopeial impurity thresholds (USP, EP, JP). Automated synthesis in ISO Class 5 cleanrooms further minimizes contamination risk and guarantees sterility.
Therapeutic Applications
Our small molecule APIs support a broad range of therapeutic areas, including:
Cardiovascular treatments (e.g., hypertension, heart failure)
Metabolic disorders (e.g., diabetes, lipid imbalances)
Antiviral and antibacterial therapies (e.g., HIV, hepatitis, bacterial infections)
End-to-End Compliance & Global Support
Abiozen supports both clinical trial and commercial-scale production, ensuring full traceability and regulatory compliance. Our deliverables include comprehensive documentation such as Drug Master Files (DMFs) to streamline the approval process and accelerate market access.
Connect with Abiozen
We thrive on tackling complex challenges—and we’d love to learn about yours. Reach out to explore how we can support your program’s unique requirements.
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