A new large scale potent API manufacturing unit at SEQENS Villeneuve-La-Garenne
Shifting needs in the pharmaceutical market are driving a stronger demand for specialized production units to manufacture highly potent active pharmaceutical ingredients ( HPAPI ) at a variety of scales.
Two major trends are actually accelerating this demand for capacity expansion:
- The growth in oncology drugs and new specialty medicines where the active molecule shows more activity than in conventional medicines
- To a lesser extent, we see today more comprehensive and demanding safety evaluation methodologies relying not only on the toxicity of the compound but also on its pharmacological effect to adopt the safest possible approaches for API manufacturing.
By building a new potent unit, Seqens is preparing for the future with the capability to address a key segment from laboratory to commercial scale.
What level of containment and how is it defined ?
Two elements need to be understood when talking about “ Potent API”
- The potency classification is relying on a core concept : the Occupational Exposure Limit or OEL, defined as the airborne concentration of a compound to which nearly all workers can be repeatedly be exposed 8 hours a day, 40 hours a week , without adverse effects.
- The effective classification is subject to an expert opinion which will go beyond the product toxicity but also consider the API final dosage and its pharmacological activity, even if not toxic.
The classification of the containment level is usually using a “Band” system to group compounds with a similar activity.
There is no
international unique guideline for this classification. This point is important
to understand when discussing with customers to refer to the same reference
The leading consultancy firm in this sector, SAFEBRIDGE, has designed a four band system to classify the API activity. Based on this categorization the VLG Unit is a “ Band Three Safebridge site “.
However, most of the CDMOs are using a 5 band system as Seqens :
|CATEGORY||OCCUPATIONAL EXPOSURE LIMIT ( μg / M3 / 8h)|
|OEB 5||0.1 – 1|
|OEB 4||1 – 10|
|OEB 3||10 – 100|
|OEB 2||100 – 1000|
A new state of the art multi-tons Band 5 API unit
Based on this classification, the new Seqens unit in Villeneuve-La-Garenne is handling category 5 compounds according to the highest standards and has started operations in October 2020.
Moreover, this plant comprises 10 new vessels up to 4500 L , several centrifuges and two filter-dryers in a high containment GMP environment allowing the production of HPAPI in multi-tons scale with batch size up to 200 kg.
It represents the final stage in the SEQENS’s strategy to offer a continuum of capabilities in potent band 5 / safebridge 3 manufacturing, from its laboratories and kilo-labs in Porcheville ( West Paris ) to its VLG Chem commercial site which was already offering HPAI capabilities up to 1500 L scale and will then become with this new investment one of the largest facility in France for that level of containment.