Containment
OEB 5 Containment CDMOs
Compare CDMOs with OEB 5 containment capabilities (<1 µg/m³ occupational exposure limit) for the most potent APIs including cytotoxic payloads and HPAPIs.
10 companies listed
About OEB 5 Containment
OEB 5 represents the highest standard of pharmaceutical containment, maintaining airborne exposure below 1 microgram per cubic meter (and often below 0.1 µg/m³). This level is required for the most potent compounds in pharma: cytotoxic payloads for ADCs, certain oncology APIs, and other highly potent active pharmaceutical ingredients (HPAPIs) that can cause serious health effects at trace exposure levels.
OEB 5 facilities require significant capital investment: fully enclosed isolator-based processing, continuous liner systems for waste removal, split-butterfly valves for material transfer, negative pressure cascades throughout the facility, multi-stage HEPA exhaust filtration, and validated decontamination procedures. The number of CDMOs with true OEB 5 capability is limited globally, making capacity planning critical for programs requiring this level of containment.
Companies (10)
AbbVie Contract Manufacturing (AbbVie CMO)
Italy
AbbVie Contract Manufacturing is an embedded CMO within AbbVie, providing third-party contract manufacturing services for over 40 years across 12 locations in the US and Europe. They offer services spanning antibody drug conjugates, aseptic fill/finish, biologics (mAbs and derivatives), custom API, eye care, hot melt extrusion, HPAPI, and oral solid dose manufacturing.
Small Molecule APISmall Molecule Drug ProductOral Solid Dose
Agno Pharmaceuticals
United States
Agno Pharmaceuticals is a U.S.-headquartered global end-to-end CDMO providing comprehensive solutions from API development and intermediates through complex drug product formulation to cGMP manufacturing for both clinical trials and commercial production. The company supports both innovative and generic pharmaceutical sectors with capabilities in small molecule APIs, highly potent APIs (HPAPIs), sterile APIs, and drug products.
Frequently Asked Questions
What compounds require OEB 5 containment?+
OEB 5 compounds include: cytotoxic ADC payloads (auristatins, maytansinoids, calicheamicins), certain traditional chemotherapy agents (nitrogen mustards, platinum compounds), potent hormonal APIs (ethinyl estradiol), and select targeted therapies with extremely high pharmacological potency. The decision is based on the compound's occupational exposure limit (OEL), which is determined by toxicological assessment.
How do you verify a CDMO's containment capability?+
Request: containment performance data (wipe sampling results, air monitoring data from routine manufacturing), equipment qualification records for isolators and containment systems, third-party containment performance verification (e.g., surrogate compound testing with naproxen sodium), worker medical surveillance programs, and the facility's containment strategy document. A site visit with containment-focused audit is strongly recommended for OEB 5 programs.
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