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Sterile API Production Capabilities
At Abiozen, we redefine sterile API production through a comprehensive, technologically advanced framework that prioritizes precision, consistency, and regulatory excellence. Our capabilities span a broad spectrum of active pharmaceutical ingredients—ranging from high-purity small molecules to complex biologics and biosimilars, potent oncology APIs, and specialty injectables tailored for rare and hormonal therapies. Each category is supported by state-of-the-art infrastructure, including ISO Class 5 cleanrooms, automated synthesis and fill-finish platforms, and robust analytical testing systems that ensure product sterility and integrity at every stage.
Abiozen’s Small Molecule APIs are synthesized with stereochemical precision and optimized for yield and reproducibility, supporting therapeutic areas such as cardiovascular health, metabolic disorders, and infectious diseases. In Biologics and Biosimilars, we leverage high-efficiency cell culture systems and single-use bioreactors to produce antibodies and therapeutic proteins with titers up to 10 g/L. Our Oncology and Critical Care APIs are manufactured in containment-controlled environments, enabling safe handling of HPAPIs and immunotherapy agents. For Hormonal and Specialty Injectables, we deliver advanced formulations—including peptides and lipid-based delivery systems—with stringent control over particle size and polymorphic forms.
Inspired by industry leaders like Curia Global and Thermo Fisher, Abiozen delivers sterile APIs with unmatched quality, scalability, and compliance—empowering global pharmaceutical innovation.
Small Molecule APIs
Abiozen delivers high-purity small molecule APIs using advanced synthesis techniques and yield-optimized processes that ensure exceptional batch consistency. Our capabilities support scalable production across therapeutic areas like cardiovascular, metabolic, and anti-infective treatments.
Biologics and Biosimilars
Leveraging cutting-edge bioprocessing and single-use bioreactors, we produce monoclonal antibodies and therapeutic proteins with titers up to 10 g/L. Our end-to-end biologics platform ensures high purity, regulatory compliance, and fast delivery from clinical to commercial scale.
Oncology and Critical Care APIs
We specialize in sterile, high-potency oncology APIs including HPAPIs and immunotherapy agents, manufactured in ISO Class 5 environments. Our containment systems and automated fill-finish lines ensure precision, sterility, and operator safety in every batch.
Hormonal and Specialty Injectables
From peptide-based APIs to hormone therapies and rare disease injectables, Abiozen excels in aseptic manufacturing and advanced particle engineering. Our focus on purity, targeted delivery, and regulatory rigor makes us a trusted partner for specialty therapeutics.
Related Resources

Sterility Validation: Testing per USP <71> and EP 2.6.1 guarantees the absence of microbial contamination, essential for injectable products.
absence of microbial contamination, essential for injectable products compliance with ICH Q3C guidelines, ensuring safety and purity residual moisture levels below 1%, critical for long-term stability. 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

Residual Solvent Testing: Gas chromatography (GC) confirms compliance with ICH Q3C guidelines, ensuring safety and purity.
compliance with ICH Q3C guidelines, ensuring safety and purity residual moisture levels below 1%, critical for long-term stability. 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

Moisture Content Analysis: Using Karl Fischer titration, we achieve residual moisture levels below 1%, critical for long-term stability.
residual moisture levels below 1%, critical for long-term stability. 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.

Sterility Validation: Testing per USP <71> and EP 2.6.1 guarantees the absence of microbial contamination, essential for injectable products.
absence of microbial contamination, essential for injectable products compliance with ICH Q3C guidelines, ensuring safety and purity residual moisture levels below 1%, critical for long-term stability. 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

Residual Solvent Testing: Gas chromatography (GC) confirms compliance with ICH Q3C guidelines, ensuring safety and purity.
compliance with ICH Q3C guidelines, ensuring safety and purity residual moisture levels below 1%, critical for long-term stability. 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

Sterility Validation: Testing per USP <71> and EP 2.6.1 guarantees the absence of microbial contamination, essential for injectable products.
absence of microbial contamination, essential for injectable products compliance with ICH Q3C guidelines, ensuring safety and purity residual moisture levels below 1%, critical for long-term stability. 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