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Safely Scaling ADC Manufacturing with OEB-6 and Double Containment

How Lugaia's High-Containment Solutions enable safe, efficient and compliant ADC Production

The biopharmaceutical industry is advancing rapidly into highly potent therapies - especially antibody-drug conjugates (ADCs) - which bring unique challenges for manufacturing, containment and operator safety. At Lugaia, we understand that meeting these challenges requires top-class containment strategies, such as OEB-6 classification and double‐containment systems, combined with flexible single-use and customized solutions. This article explains why OEB-6 and double-containment matter in ADC manufacturing, what to look for and how Lugaia’s solutions support safe, efficient operations.

1. The rise of ADCs and the containment imperative

ADCs merge a monoclonal antibody (mAb) with a highly-potent payload via a linker. These payloads are often cytotoxic and thus qualify as highly potent active pharmaceutical ingredients (HPAPIs). Because of this potency and associated exposure risks, containment is non-negotiable.

Key points:

  • ADC manufacturing typically requires facilities engineered for ultra-low occupational exposure limits (OELs).
  • The manufacturing chain (linker synthesis, antibody production. Conjugation, purification, fill-finish) spans multiple steps, each with specific containment demands. In short: when producing ADCs, containment isn’t an afterthought - it’s a foundational requirement.

2. Understanding OEB-6

The occupational exposure band (OEB) classification categorizes compounds by their toxicity/potency and sets containment expectations. For many HPAPI processes, OEB 4 or OEB 5 were once standard. But as payloads grow ever more potent, the industry is moving to OEB 6, with exposure limits in the ng/m³ range.

Key takeaways:

  • OEB 6 represents the highest practical containment level today, reserved for the most potent compounds (such as ADC payloads).
  • To achieve OEB 6, you need isolators or glove-box systems with validated leak‐tightness, negative-pressure cascades, HEPA filtration, closed transfers and typically double containment.
  • With ultra-low exposure limits, every stage (materials handling, transfer, sampling, cleaning, waste management) must be designed for containment.

 Lugaia offers its customers different security concepts with compliance for required OEL values. (OEL= Occupational Exposure Limit, OEB= Occupational Exposure Band)

3. Lugaia’s approach: Containment solutions for ADC manufacturing

At Lugaia, we bring Swiss precision and deep containment expertise to support HPAPI and ADC manufacturers. Our solution portfolio covers both single-use transfer/dispensing systems and full custom high-containment platforms geared for OEB-6 and double containment. Key value-drivers:

  • Modular single-use systems and transfer bags that reduce cleaning-validation burden, cross-contamination risk and downtime - ideal for flexible ADC process steps.
  • Custom high-containment isolators, gloveboxes and transfer systems designed for negative pressure, HEPA filtration, cascade zones and validated leak-tightness, enabling operations at OEB 6 and double-containment levels.
  • Integrated workflow support from weighing/dispensing potent compounds through safe powder handling, transfer, conjugation, sampling and cleanup, ensuring both operator safety and product integrity.
  • Proven track record: leading pharma and biotech companies trust Lugaia worldwide.
  • By delivering solutions designed from the ground up for OEB 6 and double containment, Lugaia enables safe scaling of high-potency ADC manufacturing, risk reduction, regulatory compliance and productivity gains.

 New SafePort Evo System: easy to operate within the isolator for double-containment.

Conclusion

As the ADC sector expands, demands for ultra-high containment (OEB 6) and double containment systems will only grow. At Lugaia, we believe that safe and efficient scaling of ADC manufacturing is possible when you combine deep containment expertise, flexible validated systems and forward-looking design. Whether you’re at early-stage development or scaling to commercial production, our solutions help you protect people, protect product integrity and meet regulatory demands. If you are planning an ADC process or upgrading your containment infrastructure - let’s talk about how Lugaia can support your journey.

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