Biosafety level considerations in biologic manufacturing
and aseptic filling of ATMPs

The continued development and clinical availability of advanced therapeutic medicinal products (ATMPs) have driven clinical and commercial manufacturers to adapt to greater complexities associated with production; as well additional biocontainment requirements.

Assuring the secure biocontainment of ATMPs requires manufacturers to consider each product’s biosafety level (BSL) individually to ascertain their potential risks and ways to mitigate them.

In our latest technical document, we examine the unique considerations for BSL classifications and the implications this has for downstream manufacturing, with a specific focus on aseptic filling processes.

Our analysis dives into the four BSL classifications as defined by the CDC and the various risk levels that apply to each category. These include: Our analysis dives into the four BSL classifications as defined by the CDC and the various risk levels that apply to each category. These include: –

  • BSL-1: Biological entities which pose little risk to operators and the wider environment-
  • BSL-2: Biological entities which pose a moderate risk to operators or the environment-
  • BSL-3: Biological entities that can cause serious and potentially lethal disease, especially via airborne particles
  • BSL-4: The highest level of classification given to the most severe pathogenic agents.

We also dive into the various containment measures required across manufacturing processes, as well as understanding the differences between biocontainment and bio-contaminants. Our paper also provides a deeper understanding of appropriate levels of classification, with specific regards to BSL-2 designation.

Finally, we explore how our newly upgraded facility now provides BSL-2 capabilities and supports the manufacture of diverse, life-changing ATMPs.

Learn how to accurately measure the biosafety levels of your ATMPs and properly classify them in our free technical guide available for download.

Download the resource


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