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Redox Scientific

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REDOX SCIENTIFIC

About US

Redox Scientific is a premier Contract Research, Development, and Manufacturing Organization (CRDMO), combining the capabilities of a CRO and CDMO. 

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Our Services

High Potency API Manufacturing

High Potency API Manufacturing

Small Molecule High Potency API Manufacturing Service

Redox Scientific provides high-potency small-molecule API development and manufacturing supported by contained processing, flexible reactor capacity, specialized isolation and drying equipment, and integrated analytical capabilities. From process development and scale-up to clinical-stage cGMP manufacturing, Redox supports complex small-molecule programs with a combination of technical expertise, containment-focused infrastructure and responsive project management. Redox’s entire development-to-commercial chain—from early process chemistry through cGMP production—is adapted to OEB Band 5 containment standards, giving sponsors consistent, validated containment performance at every scale.

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CAPABILITIES

Redox’s facility incorporates containment-focused equipment, extended process operating windows, and integrated solid isolation across key manufacturing operations to ensure complete handling safety and zero cross-contamination.

  • Vessel Containment: Isolator-enabled processing for 1 L to 100 L glass vessels under OEB Band 5 (OEL < 1 µg/m³) containment.
  • cGMP Suites: Dedicated high-potency suites for cGMP production equipped with independent Air Handling Units (AHUs).
  • Material Handling: Fully contained charging, sampling, and transfer systems.
  • Drying Infrastructure: Contained Vacuum Tray Dryer (VTD) integration.
  • Temperature Envelope: -78°C to +240°C operating window (process capability down to -70°C).
  • Vacuum Capability: High vacuum operation down to 1 mbar.
  • Atmosphere Controls: Inert purge capability (Nitrogen / Argon) for inert reactions
  • ANFD Filtration: 5 L, 30 L, and 300 L glass and metal ANFDs for controlled solid isolation.
  • Vacuum Tray Dryers: 6-tray contained systems for complete solvent removal under vacuum.
  • ADC Payload Handling: Dedicated capability for antibody-drug conjugate (ADC) payload and linker-payload intermediates, including cytotoxic small-molecule warheads (e.g., auristatins, maytansinoids, and calicheamicin-class compounds), manufactured under OEB5 containment with campaign-based dedicated cleaning validation to prevent cross-contamination between programs.

ADC PAYLOAD & CYTOTOXIC INTERMEDIATE MANUFACTURING

Redox’s OEB5 containment infrastructure extends to the synthesis of highly potent ADC payloads and linker-payload conjugation intermediates, supporting sponsors moving cytotoxic warheads from preclinical development through clinical-stage cGMP supply.
  • Payload Classes: Tubulin inhibitors (auristatins, maytansinoids), DNA-damaging agents (calicheamicins, duocarmycins, PBDs), and topoisomerase inhibitors.
  • Linker-Payload Intermediates: Cleavable and non-cleavable linker synthesis and conjugation-ready intermediate manufacturing under contained processing.
  • Segregation & Cleaning: Campaign-dedicated equipment trains and validated cleaning protocols to prevent cross-contamination between cytotoxic programs.

INTEGRATED ANALYTICAL SUPPORT for High-Potency API Programs

Analytical development and testing are integrated directly alongside Redox’s development and manufacturing suites. Associated UPLC units allow immediate in-process (IP) sample testing in the same contained area without delay.
  • In-Area UPLC: Dedicated UPLC units located directly inside the contained processing zone for rapid in-process (IP) feedback.
  • Testing Scope: Raw material release, intermediate testing, IP monitoring, impurity profiling, cleaning validation, ICH stability programs, and Certificate of Analysis (COA) generation.

cGMP / CLINICAL MANUFACTURING

Redox supports small-molecule programs through process development, kilo-lab manufacturing, pilot-scale batches, validation batches, and cGMP API manufacturing.
  • Process Development: Route evaluation, critical process parameter (CPP) studies, process optimization.
  • Kilo-Lab Manufacturing: Scale-up and non-GMP development quantities.
  • Clinical Manufacturing: Phase I, Phase II, and Phase III clinical trial materials.
  • cGMP Drug Substance: Commercial API supply, advanced intermediates, and registered starting materials (RSM).