From stomach protection agents to drugs for the treatment of respiratory distress in preterm infants – Singen-based Takeda GmbH plays an important role as a competence centre for drugs in liquid and semi-solid dosage form within the Japanese pharmaceutical company’s global network. Besides the production of around 68 million packages per year, the company’s production site in Singen also focuses on drug development. The company’s CMC Centre further develops existing drugs, designs new dosage forms and identifies new application areas for known drugs.
In the development of a drug for a particular indication, it is not the active ingredient alone but also the administration route that plays a crucial role in the drug’s effectiveness. Depending on the active agents and the indication for which they are used, common dosage forms include tablets, infusions and ointments. Various dosage forms may exist for a particular drug, and the drugs have to be specifically adapted to the way they are administered, which is a complex process. The Takeda production site in the city of Singen in the south of Germany, is therefore specifically focused on the dosage form of drugs rather than on specific medications.
"Put simply, here in Singen we develop and produce drugs that are administered in the form of infusions or nasal sprays,” says site manager Dr. Jürgen-A. Mahling. The Japanese Takeda Group is a global leader in the pharmaceutical industry and, following the acquisition of the pharmaceutical company Nycomed in 2011, is also present in the south of Germany. The company site in Singen is Takeda’s largest in Germany, which is one of the most important pharmaceutical markets in Europe as well as of major importance for Takeda as a reference country in the European pharmaceutical market.
With around 68 million packages per year, the Takeda production site in Singen covers a major part of the global demand for liquid and semi-solid medications. “We are mainly producing for the international market; only two percent of the drugs produced and packaged here in Singen are destined for patients in Germany,” says Mahling.
In Singen, the company mainly produces aseptic, freeze-dried, non-sterile liquid and semi-solid dosage forms such as pantoprazole injections (an intravenous drug used for reducing the amount of acid produced in the stomach). In addition to production, Takeda’s company site in Singen also has a “CMC Centre” (Chemistry, Manufacturing and Control) that works on the development of new drugs and the enhancement of existing drugs. CMC departments of pharmaceutical companies are usually responsible for preclinical development processes such as the identification and documentation of the physicochemical properties of new drug candidates.
Takeda’s CMC Centre is a global organization with its main sites in Japan and the USA. The company’s CMC Centre in Singen specializes in the development of nasal, inhaled and dermal dosage forms, i.e. sprays, aerosols and ointments. A staff of 30 is involved in analytical and pharmaceutical development, project management and quality assurance activities. “Although we do not do classical drug discovery, i.e. the discovery of new substances, our work does involve the development of new products,” says Dr. Daniela Bundschuh who is in charge of the CMC Centre in Singen. Takeda’s CMC Centre in Singen is working on the development of novel dosage forms containing active substances developed by Takeda as well as on the further development of substances that are already on the market.
“We are currently working intensively on the development of an ointment formulation for treating inflammatory skin diseases such as psoriasis and eczema,” says Bundschuh. The pharmaceutical substances have been discovered and developed by Takeda and have already shown their anti-inflammatory effect in other indications. “We have carried out clinical tests on patients with psoriasis and atopic dermatitis and have been able to demonstrate excellent anti-inflammatory efficacy,” Bundschuh added. As far as nasal and inhaled dosage forms are concerned, we are currently further developing products that are already on the market, including an electronically controlled nasal spray for the treatment of breakthrough pain in cancer patients. Another important task of the CMC Centre in Singen is the generation of a recombinant drug for the treatment of respiratory distress in preterm infants.
The CMC Centre in Singen is a relatively small unit and therefore dependent on intensive collaboration with other companies as it cannot own all the necessary technologies itself. “We are already working with numerous small and medium-sized companies located in the Singen region as well as with international companies, especially on the development of new technical devices and analytics,” says Bundschuh.
The areas of production and CMC are closely linked due both to their proximity at the company’s site in Singen and the joint use of the existing infrastructure. In addition, the production areas provide considerable technical support, for example for the qualification of the production plant, microbiological monitoring and quality control, and also carry out analyses as well as release tests of raw materials and finished formulations used by the company’s CMC Centre. In turn, the CMC Centre contributes with skills that the production areas lack. “The CMC Centre was recently able to considerably improve the reliability of the characterization of a drug using a new analysis method,” says Mahling, referring to the interaction between the company’s production and CMC areas.
With around 600 staff in drug production and more than a hundred in areas such as R&D, Takeda is one of the largest employers in the region. The importance of the Singen site for the Takeda Group was recently underlined by Takeda’s multi-million investment in the expansion of the Singen-based production plants. The construction of a new production building, which is set to become operational in 2015, will considerably expand the company’s production capacities and create around 100 new jobs in Singen.
Further information:Takeda Pharma Vertrieb GmbH & Co. KGCorporate Communications Matthias ReinigTel.: +49 (0)30 206277-0E-mail: matthias.reinig(at)takeda.com