Our PureActives® are APIs produced using our proprietary, sustainable, and environmentally friendly enzymatic technology. They bring our brand promise to life through superior quality, outstanding reliability and leading sustainability performance. All our manufacturing sites use the best available technology and operate dedicated waste water treatment plants, 24/7 throughout the year. Effluents are regularly sampled and checked for antimicrobial activity.
The traditional process for making antibiotics required the use of many harmful solvents and chemicals. Our enzymatic technology has nearly eliminated the use of chemicals and solvents. Consequently, no chemical residues will end up in the final product. In addition, our innovative PureActives® have a higher over all quality than the comparable chemical product. This shows among other things in a higher purity, a longer shelf life and significant improvements in carbon footprint, which benefits manufacturers, patients and society.
The high purity of PureActives® API - higher than any other equivalent product in the market - is a characteristic which is successfully used as a unique selling point by our customers. The reduced toxicity owing to the absence of most residual solvents is valued by doctors and patients.
Our product tastes better due to the absence of most residual solvents. Suspensions and syrups often need to cover the dominant smell and taste of for example residual solvents in the API. Formulations based on PureActives® are odor and tasteless and therefore valued over chemically produced ingredients by customers, doctors and patients.
The outstanding stability of PureActives® API gives formulators an excellent starting point for a formulation process that will result in stable dosage forms. Of course there are many other important factors to control like the formulation process, handling and packaging.
The high purity of PureActives®, allows customers to increase yield per kg and increase machine output.
Thanks to the high stability of PureActives® the assay of the ingredient stays within pharmacopoeia limits for a longer period of time. This means that the amount of ingredient that is needed at the moment of formulation is much closer to the amount that is guaranteed at the end of shelf life.
Formulators can materialize this advantage by reducing the amount of excess material that is dosed into the dosage form to guarantee the end of shelf life activity.
Our batch sizes are up to 10 times bigger compared to competitors. Consequently, tests performed on incoming batches can be reduced by a similar factor. In addition, the limited number of impurities reduces the number of tests that need to be performed per batch.
A typical characteristic of all PureActives® products is the greatly reduced number of impurities. During the registration process formulators are frequently asked for additional information about impurities found in the active ingredient. As the number of impurities in PureActives® is less than in the chemically produced alternatives, the efforts and costs needed for new registration and maintenance of existing dossiers can be reduced.
The most important aspect is the long shelf life whereby obsoletes can be reduced. Large batch sizes also reduce the amount of administrative work and utilization of IT resources. If a formulator is able to translate the longer shelf life of the API into a longer shelf life of his formulated product, this will result in reduced obsoletes in the down-stream value chain (distribution and pharmacies).
Operators in the formulation industry are in daily contact with the active pharmaceutical ingredient. Companies take thorough safety and health precautions to minimize this contact. By using PureActives®, the comfort in use for operators can be further optimized. The absence of nearly all residual solvents means the product is odorless. Thanks to the physical properties of some of the PureActives® grades, the product generates less dust during handling.
The most important improvement from a sustainability point of view is the absence of aggressive solvents. We use our own enzymes to modify our molecules and to for example couple the side chain to make 6-APA or 7-ADCA molecules; all this occurs without using solvents.
Another improvement can be assigned to the reduction in process steps. The less steps a process has, the less the burden on the environment. Thanks to the enzymatic process, the number of process steps can be drastically reduced. For some products the number of steps can be reduced by more than 50%.
All enzymatic reactions take place at ambient temperatures. The old chemical process had to run at very low temperatures, requiring significant energy for cooling.
Read more about Sustainable Antibiotics here.