Handheld Test Kits
The test procedure used in handheld test kits, or lateral flow assay, is based on the principle of antigen-antibody interaction. It is also referred to as immunochromatography for its chromatographic properties. You are familiar with these test systems. They are used for diagnosing diabetes, or as pregnancy tests. Whether these test systems will be introduced, and whether they will be produced locally is entirely subject to the medical demand for such systems. It is important to take a closer look at two aspects: First, the use of rapid tests to accelerate the diagnosis of diseases and second, their possible use in responding to biological attacks. According to international legal interpretation and the Biological Weapons Convention2, an internationally binding treaty adopted by the United Nations General Assembly in 1971, biological weapons are banned. The Convention has been ratified by 178 states to date. There are countries that reject change and dialogue with the rest of the world. In some cases, their leaders are trapped in an imagined conflict with other countries, and perceive overwhelming conventional superiority as a threat, spurring their motivation to at least acquire such weapons. The risk of biological attacks launched by asymmetric forces, though, is even less predictable than the threat posed by national states. While classical asymmetric warfare was mainly focused on wearing down a superior military opponent by launching surprise attacks, terrorists may also use this tool, eventually turning the whole world into their base of operations. Biological weapons are pathogens or their toxins that are deliberately used as weapons. Such weapons may not only be targeted at humans, but also at animals, plants or even equipment. The Center for Disease Control and Prevention (CDC), a United States agency, has divided biological weapons into three categories3. Based on this classification, the CDC prepared a list of pathogens that they consider to be the most likely biological weapons to be used in an attack. The twelve pathogens identified, or their toxins, are generally referred to as the "Dirty Dozen". They are likely to be in the focus of interest of terrorist forces planning biological attacks. States, politicians, and the general public are becoming increasingly aware of the threat posed by bioterrorism. Although criminal forces have not staged a large-scale or widespread biological attack so far, the 2001 anthrax attacks left a deep mark. The need to identify pathogens as early as possible requires sensitive test kits for the detection of potential biological agents. There is, however, only a very limited civilian market, if any, for these products; a fact that
significantly reduces any opportunities of profit creation. This results in a diminished commercial interest, or none at all, in developing such products. The systems used by the requesting Bundeswehr agency, the Bundeswehr Institute of Microbiology, were all special productions. It pushed up unit production cost dramatically. This situation was further aggravated by the fact that production was always subject to available commercial production capacity. These products are of high interest for the Bundeswehr. The manufacturing process, however, remains a challenge from a technical point of view.
After having presented products that are already produced or are new to the pharmacy as manufacturer, supply is another main task. This task also covers the procurement and distribution of medical consumable material, i.e. medicinal products and medical devices, furthermore pharmacy-scale production in contrast to production on an industrial scale. But "supply" also contains tasks stipulated by law that are classified as pharmaceutical services. Pharmacy-scale production includes compared to industrial-scale production the preparation of formulations such as sterile solutions, eye drops, ointments and capsules in accordance with individual patient requirements. The individual preparation of cytostatic dru