Producers of high potency drugs should be equipped with isolators, such as glove boxes, and the people handling them should be skilled in using them. Expertise is also required in handling steroids, some used in anti-cancer therapy and hormones.
In 2002 the National Center for Health Statistics stated that cancer was the second leading cause of death in the USA, accounting for about 30 per cent of all deaths. For every type of cancer, and in many cases for every patient, there is a potentially different drug to be used as an effective medication.
Earlier anti-cancer drugs targeted only cells in the cell cycle and did not take into account the uniqueness of every type of cancer. Advanced clinical research is shedding light on the specific therapeutic targets and pharmacological research is entering into a new era of targeted molecules.
Anti-cancer drugs are generally referred as ‘highly potent’. Some of the drugs are complex molecules of natural origin that are purified and then subjected to chemical synthesis. Usually, the production process has to be performed in a controlled environment.
Steroid market leader
Sicor Srl is a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd, API division. Founded in 1983, Sicor’s portfolio includes over 70 products and it specialises in the area of steroids and potent drugs. Sicor operates three sites, two located in Italy, and one in Switzerland.
Its products are used in oral, parenteral, topical and inhalation therapies, and most fall into four classes:
- Steroids
- Oncolytics
- Non-depolarising muscle relaxants
- Immunosuppressants
Since 1988, Sicor’s fermentation and downstream plant, specially built for potent drugs, has exclusively produced anti-cancer drugs. Since 1983, the plant has been regularly inspected by health agencies and achieved an excellent record of results.
Technologies used in Sicor, both in R&D and production, are chemical synthesis, fermentation and large-scale chromatography, all run in confined systems to handle even the most potent compounds.
Sicor is part of Teva API’s global R&D, thus combining the long experience of Sicor in steroids, potent drugs and natural compounds with Teva’s vast and focused knowledge in API development and enhancing flexibility in handling projects. Custom synthesis activities are focused on the same line of compounds that are produced in its industrial plants, addressing both natural and synthetic drugs.
Good manufacturing practice
Sicor considers itself a long-term partner to its customer, from the workbench to industrial production, covering regulatory aspects. Sicor’s R&D operates two pilot plants – one of them devoted to anti-cancer drugs – that can both be run in GMP in compliance with FDA and European regulatory agencies requirements, allowing the production of small active pharmaceutical ingredients batches to be used in clinical phases.
Fermentation can handle unicellular bacteria, actinomycetes and moulds, either natural or recombinant. The downstream processing is performed in a closed cycle and finishing and purification areas are equipped with ad hoc isolators. Process chromatography can be performed in low, medium or high pressure, either direct or reverse phase.
Isolator technology is completely integrated into R&D facilities, which are then able to run chemical synthesis, fermentation and chromatography in a protected environment. This is further enhanced by two lyophilisation units (pilot and production), which are incorporated into process glove boxes.