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CDMO Services

Accelerating Your Molecule from Concept to Commercialization

At Abiozen, we deliver comprehensive Contract Development and Manufacturing (CDMO) services tailored to the evolving needs of pharmaceutical innovators. From early-stage formulation to commercial-scale production, our integrated approach ensures seamless transitions, regulatory excellence, and accelerated time-to-market. Backed by GMP-certified facilities and a commitment to quality, we empower pharmaceutical companies worldwide to bring small molecules, biologics, and sterile injectables to market with confidence and speed.

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cdmo pharmaceutical manufacturing

Integrated Capabilities

From Molecule to Market, Seamlessly Delivered

Formulation Development

Our formulation development services focus on enhancing solubility, bioavailability, and patient-centric delivery using advanced technologies like nanotechnology, lipid-based systems, and controlled-release platforms. Abiozen’s scientists tailor each formulation based on clinical requirements and scalability, conducting rigorous excipient compatibility and pre-formulation studies. Whether for oral, injectable, or complex molecules, we ensure each drug product is optimized for therapeutic performance, regulatory readiness, and manufacturing feasibility.

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Process Optimization

Abiozen applies a data-driven, science-first approach to streamline manufacturing processes, reduce variability, and drive efficiency. Using methodologies like Design of Experiments (DoE) and Statistical Process Control (SPC), we identify optimal parameters that translate into consistent, high-quality outcomes. Our teams focus on scalability, process robustness, and regulatory alignment to help clients reduce development timelines, mitigate risk, and increase operational throughput from lab to commercial production.

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Scale-Up Manufacturing

From pilot-scale trials to full commercial output, our manufacturing infrastructure supports seamless scale-up across diverse product categories. We offer high-volume API synthesis using advanced reactors and automated systems to ensure precision and consistency. Our GMP-compliant facilities feature ISO Class 5 cleanrooms and cutting-edge equipment, enabling the reliable production of sterile injectables and complex formulations at global scale, with rigorous in-line quality control for every batch.

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Custom Synthesis & Lyophilization

Our custom synthesis capabilities allow for the production of complex, high-potency molecules, including peptides and chiral compounds, using techniques like flow chemistry and microwave-assisted synthesis. Complementing this, our advanced lyophilization systems enhance product stability and shelf life through precise freeze-drying under aseptic conditions. These specialized services ensure molecular integrity, sterility, and long-term storage feasibility, meeting the most demanding clinical and commercial requirements.

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Analytical Testing & Stability Studies

Our analytical labs deliver robust, ICH-compliant testing services that support drug development from R&D through post-market surveillance. We develop and validate methods using HPLC, GC, and spectroscopy while conducting rigorous batch release testing and contamination control. Stability studies under various conditions generate critical shelf-life data for global regulatory submissions, giving our clients full confidence in product quality, safety, and performance across the product lifecycle.

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Expertise across the entire drug development lifecycle

IND Enabling Services

Accelerate regulatory filings with expert IND strategies that ensure speed without compromising quality.

Analytical Testing

Comprehensive analytical support delivering purity, potency, and regulatory-ready data.

Process Development

Resolve early-stage challenges with scalable, validation-ready process design.

Clinical Trial Material Production

GMP-compliant CTM manufacturing with full aseptic processing and flexible batch sizes.

Clinical Supply & Logistics

Global distribution with real-time tracking and packaging tailored to trial protocols.

Trial Management & Biostatistics

Adaptive trial execution with real-time data and regulatory-grade statistical insights.

Commercial Scale Manufacturing

Seamless scale-up to high-volume production with automated sterile filling lines.

Technology Transfer

Validated, risk-mitigated process transfer ensuring global compliance and consistency.

Packaging & Serialization

End-to-end packaging with global serialization and multilingual compliance solutions.

Generic API Manufacturing

High-quality, scalable API production with regulatory-aligned synthesis protocols.

Intermediates and RSMs

Reliable supply of key intermediates and starting materials with global reach and control.

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CDMO Services

Accelerated Market Access with CRDMO-Style Development & Manufacturing

property and compliance solutions for seamless market entry processes for superior purity and stability. global demand. 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

Two colleagues in a meeting room discussing financial charts and graphs on a laptop and paper.
CDMO Services

Integrated API to Commercial Manufacturing: The Patheon Parallel

property and compliance solutions for seamless market entry processes for superior purity and stability. global demand. 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

Two colleagues in a meeting room discussing financial charts and graphs on a laptop and paper.
CDMO Services

Curia-Level Excellence in End-to-End Drug Development Solutions

property and compliance solutions for seamless market entry processes for superior purity and stability. global demand. 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

Two colleagues in a meeting room discussing financial charts and graphs on a laptop and paper.
CDMO Services

Accelerated Market Access with CRDMO-Style Development & Manufacturing

property and compliance solutions for seamless market entry processes for superior purity and stability. global demand. 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

Two colleagues in a meeting room discussing financial charts and graphs on a laptop and paper.
CDMO Services

Integrated API to Commercial Manufacturing: The Patheon Parallel

property and compliance solutions for seamless market entry processes for superior purity and stability. global demand. 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

Two colleagues in a meeting room discussing financial charts and graphs on a laptop and paper.
CDMO Services

Accelerated Market Access with CRDMO-Style Development & Manufacturing

property and compliance solutions for seamless market entry processes for superior purity and stability. global demand. 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

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