Highly Potent Compounds
Specialized HPAPI Handling & Precision Powder Filling from Clinical Through Commercial Scale
Experic provides specialized development and manufacturing capabilities for highly potent active pharmaceutical ingredients (HPAPIs) and low-dose powder formulations, combining OEB5 containment, precision powder filling, advanced Harro Höfliger equipment, and rigorous cGMP controls.
High-Potency & Low-Dose Powder Filling
Highly potent compounds demand precise dosing, robust containment, and specialized expertise at every stage of manufacturing. Experic provides clinical- and commercial-scale powder filling for HPAPIs and low-dose formulations below 0.5 mg, with capabilities designed specifically for potent powder encapsulation.
Experic’s high-potency manufacturing approach combines advanced equipment with containment and risk planning to support challenging formulations while maintaining consistent product quality and operator safety.
- Highly potent compound handling through OEB5
- Low-dose powder filling for formulations below 0.5 mg
- Precision powder encapsulation
- Clinical- and commercial-scale manufacturing
- Containment and risk planning
- Integrated analytical testing, packaging, and clinical supply support
HPAPI Manufacturing Capability Matrix
| Capability | Experic Approach | Program Benefit | |
|---|---|---|---|
 | High-Potency Handling | Containment through OEB5 | Secure, controlled handling of OEB5 substances |
 | Low-Dose Filling | Powder filling at weights below 0.5 mg | Precision dosing for potent formulations |
 | Containment | Isolators, negative-pressure systems, and high-containment procedures | Reduced operator and environmental exposure risk |
 | Encapsulation | Harro Höfliger Modu-C CS technology | Scalable, high-precision capsule filling |
 | Cleaning & Changeover | Cleaning validation and cross-contamination prevention protocols | Supports product integrity and multi-product manufacturing |
 | Scale-Up | Clinical through commercial manufacturing | Greater continuity as programs advance |
 | Quality & Compliance | cGMP QMS and alignment with FDA and EMA requirements | Controlled development and manufacturing environment |
OEB5 Containment for Highly Potent Compounds
Experic’s HPAPI capabilities are designed around the heightened containment requirements associated with highly potent compounds. Advanced isolators, negative-pressure systems, restricted access, specialized PPE, and defined handling procedures help minimize exposure risks while maintaining product integrity.
Our facility’s high-containment infrastructure supports OEB5 compounds in a contained environment below 0.05 µg/m³. Manufacturing controls are designed to protect operators and the surrounding environment while maintaining appropriate temperature, relative humidity, purity, and other conditions required for sensitive products.
- Advanced isolator technologies
- Negative-pressure environments
- Restricted access controls
- Specialized PPE and handling procedures
- Personnel training for high containment operations
- Cleaning validation protocols
- Cross-contamination prevention strategies
Scalable HPAPI Programs Powered by Harro Höfliger Technology
Experic’s strategic relationship with Harro Höfliger provides access to advanced equipment specifically suited to high-potency and precision powder-filling applications.
The Harro Höfliger Modu-C CS containment platform supports OEB5 manufacturing and is capable of processing up to 43,500 capsules per hour. Its contained design provides protection for the product, operators, and manufacturing environment while enabling tightly controlled encapsulation operations.
Experic’s flexible manufacturing infrastructure is designed to support highly potent programs as batch requirements evolve from clinical development toward commercial production.
Processes established in manufacturing suites can transition to higher-speed equipment as volume requirements increase. Experic also maintains approximately 40,000 square feet of flexible gray space at its Cranbury facility that can be configured around customer-specific requirements and future commercial manufacturing needs.
Integrated Packaging, Storage & Distribution for Highly Potent Compounds
Experic provides customizable cGMP packaging, labeling, and kitting; temperature-controlled storage; clinical supply chain management; global distribution; returns and reconciliation; and destruction services for early- through late-phase trials.
With manufacturing and analytical capabilities in Cranbury, New Jersey, and a clinical trial supply depot in Kilbeggan, Ireland, Experic can also support clinical supply activities across U.S. and European programs.
Frequently Asked Questions
High-Potency Manufacturing
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Experic provides specialized manufacturing and powder-filling capabilities for highly potent APIs and low-dose formulations, including OEB5 containment, precision encapsulation, clinical and commercial manufacturing, analytical testing, packaging, and supply support.
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Experic is equipped to safely handle highly potent compounds through OEB5, supported by advanced containment equipment, isolators, negative-pressure systems, specialized handling procedures, and cleaning validation protocols. Its Harro Höfliger Modu-C CS equipment supports a contained environment below 0.05 µg/m³.
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Yes. Experic supports precision powder filling for low-dose formulations below 0.5 mg, as well as highly potent APIs, using specialized powder-handling and encapsulation equipment. Capabilities extend from clinical manufacturing through commercial-scale production.
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Experic combines advanced isolators and negative-pressure systems with specialized PPE, personnel training, high-containment handling procedures, and stringent cleaning validation protocols. These controls are designed to protect operators and the environment while maintaining product integrity and minimizing cross-contamination risk.
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Yes. Experic provides clinical- and commercial-scale manufacturing within flexible infrastructure designed to accommodate changing production requirements. Its strategic relationship with Harro Höfliger provides access to scalable equipment technology, helping facilitate knowledge transfer and mitigate technical risk as programs progress toward commercial production.