GEA pharmaceutical test center boosts research. A unique facility in Copenhagen is offering pharmaceutical companies the chance to test the spray drying process for manufacturing new drugs. This cuts research time, while ensuring the best quality product, and means patients can benefit from new medicines sooner.
When a new medicine is discovered it will be at least ten years before it is available for doctors to prescribe to patients. The route from laboratory to market involves rigorous clinical trials to ensure safety, quality and efficacy. All the trial data then have to be reviewed by the regulatory authorities. Only if the review is successful will approval be given for the drug to be marketed.
Costs and Time - decisive factors for product innovation
Because the manufacturing process is stipulated in the approval, it is very difficult to change. So it is essential to get it right first time. Building a production facility, installing the equipment and having it validated to strict quality regulations can take more than two years. And, given that only small batches are required for clinical trials and that drugs may fail at the trial stage, this phase is extremely costly and time consuming.
Another time issue is the patent life. A patent lasts 20 years from when it is filed, which is usually when the new drug candidate is identified. But, by the time the product protected by the patent reaches the market, there could be just ten years left.
GEA Niro, part of GEA Process Engineering, has established a pharmaceutical test station for spray drying in Copenhagen that enables its customers to make products for clinical trials and evaluate the production process without the need for early investment in plant or expertise.
The center, located just 15 kilometres from the airport, opened two years ago. Since then it has been running at full capacity and new equipment will be added next year to meet demand.
The center is equipped with the latest spray drying technology for realistic testing or, in many cases, for full production scale. It dries solutions, suspensions and emulsions into powders for final oral dosage drugs.
New test center saves time and money
“This is a unique facility,” explains Manager Michael Wahlberg. “Our equipment is built according to the EU’s GMP (good manufacturing practice) standards and has been approved by the Danish Medicines Agency.” And he adds: “Customers can have small batches produced for clinical and preclinical testing so they don’t have to buy the entire equipment. Because it takes time to build equipment and have it validated, the test center enables pharmaceutical companies to save time and money.”
Manufacturing small batches makes it easier to try out new processes. This provides valuable support to the validation process, and for the customer project team, reducing the commissioning period of the commercial production equipment.
Currently the center’s spray drying plant, called a PHARMASD™, size PSD-4, has a drying gas rate of 1,250 kg/h. The new dryer currently being installed – the PHARMASD™, size PSD-1 – has a drying gas rate of 80 kg/h and will be used for making smaller batches.
“There are exciting times ahead,” says Wahlberg. “More and more pharmaceutical companies are considering making drugs as powders for inhalation or using the spray drying technology for increasing the bioavailability of the drugs. We have great expectations for the future.”
GEA Process Engineering and the pharmaceutical industry
GEA Niro has supplied the pharmaceutical industry with drying plants for producing powders and particulates for more than 70 years. The pharmaceutical processing equipment includes low capacity dryers designed for specialist potent powders as well as industrial size plants for continuous operations performed under strict hygienic standards. Product applications include analgesics, antibiotics, enzymes, proteins, vaccines and vitamins. GEA Pharma Systems supplies additional processing equipment and plant types to the pharmaceutical industry. They include fluid bed tablet coaters, granulators and dryers, as well as microwave dryers. GEA Niro also supplies individual plants or engineering of complete processing lines to the chemical, food and dairy manufacturing industries.