Abiozen

Oncology and Critical Care APIs

Abiozen’s capabilities in oncology and critical care API manufacturing are engineered to meet the highest standards of precision, safety, and therapeutic efficacy. We specialize in the sterile production of high-potency compounds, including cytotoxic and HPAPIs, within facilities designed for stringent environmental and occupational safety controls.

Targeted Therapeutic Focus

Our portfolio supports a wide range of life-saving applications. We manufacture APIs for targeted cancer therapies, including tyrosine kinase inhibitors, PARP inhibitors, and immune checkpoint modulators that form the backbone of precision oncology. In the immunotherapy space, our APIs enable CAR-T cell therapies, bispecific antibodies, and cytokine-based treatments. We also produce supportive care medications such as pain management agents, antiemetics, and anticoagulants—critical in high-risk, acute care settings.

Operator Safety and Containment Systems

To ensure both operator and product safety, we utilize glovebox isolators and closed-system transfer devices (CSTDs) for safe handling of HPAPIs and cytotoxics. ISO Class 5 cleanrooms, continuous air quality monitoring, and HEPA filtration maintain a sterile production environment, ensuring integrity across every batch.

Compliance and Technical Excellence

Our operations strictly adhere to USFDA, EMA, and ICH guidelines. Inspired by Curia Global’s advanced practices, we maintain dedicated suites for HPAPI production with integrated decontamination and waste management protocols. Automated sterile fill-finish lines further reduce human intervention, ensuring consistent product sterility and precision in packaging and vial filling.

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.

Related Resources

Two colleagues in a meeting room discussing financial charts and graphs on a laptop and paper.
Oncology and Critical Care APIs

Automated sterile fill-finish lines minimize human intervention, ensuring precision and sterility in vial filling and packaging.

for HPAPIs, equipped with decontamination protocols and waste management systems to uphold safety and environmental standards. real-time environmental monitoring to guarantee sterility. rapid delivery of clinical and commercial batches. (up to 2,000 L) to eliminate cross-contamination risks and enable flexible manufacturing. bacterial infections. syndromes. Cardiovascular Treatments: APIs for managing hypertension,

Two colleagues in a meeting room discussing financial charts and graphs on a laptop and paper.
Oncology and Critical Care APIs

High-Potency API Manufacturing with Advanced Containment and Compliance

for HPAPIs, equipped with decontamination protocols and waste management systems to uphold safety and environmental standards. real-time environmental monitoring to guarantee sterility. rapid delivery of clinical and commercial batches. (up to 2,000 L) to eliminate cross-contamination risks and enable flexible manufacturing. bacterial infections. syndromes. Cardiovascular Treatments: APIs for managing hypertension,

Two colleagues in a meeting room discussing financial charts and graphs on a laptop and paper.
Oncology and Critical Care APIs

Automated sterile fill-finish lines minimize human intervention, ensuring precision and sterility in vial filling and packaging.

for HPAPIs, equipped with decontamination protocols and waste management systems to uphold safety and environmental standards. real-time environmental monitoring to guarantee sterility. rapid delivery of clinical and commercial batches. (up to 2,000 L) to eliminate cross-contamination risks and enable flexible manufacturing. bacterial infections. syndromes. Cardiovascular Treatments: APIs for managing hypertension,

Two colleagues in a meeting room discussing financial charts and graphs on a laptop and paper.
Oncology and Critical Care APIs

High-Potency API Manufacturing with Advanced Containment and Compliance

for HPAPIs, equipped with decontamination protocols and waste management systems to uphold safety and environmental standards. real-time environmental monitoring to guarantee sterility. rapid delivery of clinical and commercial batches. (up to 2,000 L) to eliminate cross-contamination risks and enable flexible manufacturing. bacterial infections. syndromes. Cardiovascular Treatments: APIs for managing hypertension,

Two colleagues in a meeting room discussing financial charts and graphs on a laptop and paper.
Injectable APIs

Automated sterile fill-finish lines minimize human intervention, ensuring precision and sterility in vial filling and packaging.

for HPAPIs, equipped with decontamination protocols and waste management systems to uphold safety and environmental standards. real-time environmental monitoring to guarantee sterility. rapid delivery of clinical and commercial batches. (up to 2,000 L) to eliminate cross-contamination risks and enable flexible manufacturing. bacterial infections. syndromes. Cardiovascular Treatments: APIs for managing hypertension,

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