Corealis Pharma CDMO is fully equipped to handle potent compounds, which require more rigorous containment due to their high pharmacological activity and occupational exposure limits. Corealis routinely handles potent compounds as low at 1 µg/m³ (range 1 – 10 µg/m³). This corresponds to SafeBridge Category 3/4 or more precisely 3B.
Our facility features robust engineering controls, including isolators and specialized air handling systems, ensuring the safe and compliant development and manufacturing of these compounds. With a proven track record in managing potent molecules, Corealis provides clients with confidence, compliance, and quality at every stage of their product’s journey.
SafeBridge Potency Classification System (Adapted to Qualify Corealis’ Facility)
Category 1 – Low Potency
- OEL: Typically ≥ 1000 µg/m³
- Characteristics: Minimal pharmacological/toxicological activity at low concentrations.
- Containment: Standard GMP practices; minimal containment needed.
Category 2 – Moderate Potency
- OEL: 100–1000 µg/m³
- Characteristics: Moderate pharmacological/toxicological activity.
- Containment: Basic containment measures (e.g., closed systems, local exhaust ventilation).
Category 3 – Potent Compounds
- OEL: 10–100 µg/m³
- Characteristics: High pharmacological activity or potential for significant toxicity.
- Containment: Advanced containment (e.g., isolators, glove boxes, specialized HVAC systems).
Category 3B – Highly Potent Compounds
- OEL: 1–10 µg/m³
- Characteristics: High pharmacological activity or potential for significant toxicity. Very high activity or toxicity; includes many cytotoxic and select hormone-modulating drugs.
- Containment: Advanced containment (e.g., isolators, glove boxes, specialized HVAC systems).
Category 4 – Highly Potent / Cytotoxic Compounds
- OEL: <10 µg/m³ (often <1 µg/m³)
- Characteristics: Very high activity or toxicity; includes many cytotoxic and hormone-modulating drugs.
- Containment: Maximum containment measures; strict controls and PPE protocols.
Potent Compounds Handling Development Services
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Corealis’ experts are ready to answer any queries about the company’s oral solid dose offering, including its development and manufacturing capabilities.
