API Production

Active Pharmaceutical Ingredients

The active pharmaceutical ingredient (API) of a medicine is the substance that exerts the therapeutic effect. In everyday language they are often referred to as drugs. Drugs are a wide range of different substances and can be classified as natural products, semisynthetic or synthetic, or biotechnological products. While the majority of drugs until now have been synthetic molecules, the number of new medicines of biotechnological origin, including genetically modified molecules, has been increasing.

In the case of synthetic drugs, stereochemical aspects often play a role; often only certain enantiomers have the desired biological effect. Such drugs require either specific synthesis of only one enantiomer or separation of enantiomers after synthesis.

Synthetic drugs are manufactured using a large number of process steps; these need to be coordinated as well as possible. On the one hand there is the need to use production lines flexibly and on the other, cross-contamination of the different APIs must be avoided. It is increasingly important to utilise the capacities of production plants worldwide as efficiently as possible. The key to meeting these challenges lies in the optimisation of the processes. Integration of the whole process from incoming goods to the finished product reduces costs and cycle times; safety of personnel can be improved, even in Ex zones; and impurities in the product can be reduced to a minimum.

The ZETA Advantage

ZETA offers a full portfolio of services and products from concept design to installation of integrated and automated system components:

  • Preparation – foundation of successful production
  • Reaction – from process to product
  • Separation and purification – step by step to a pure active ingredient
  • Conditioning – the perfect finish

The better the preparation, the better the product. This is not just about preparation of the quality-controlled raw materials by weighing, milling or mixing, but also about the GMP-compliant, documented execution of all part processes with the correct ingredients – at the right time and in the right quantity and quality.

In the central process of drug synthesis, the highly diverse reactions, reactor types and reaction rates demand the maximum of flexibility from the processing plant. Only in this way can reactions that run in parallel and sequentially be properly coordinated. And only in this way can the requirements for safety, reaction kinetics, heat transfer and mass transfer be met.

In the separation and purification steps, the last impurities must be removed from the active ingredient; whether by filtration, crystallisation, milling, sieving, drying, centrifugation or by combinations of several methods.

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