Verapido Medical GmbH is a medical device company based in Villingen-Schwenningen (Germany) that develops and manufactures devices with which liquid drugs can be administered intradermally, i.e. into the skin rather than below the skin. The company’s microneedle technology looks to have several advantages over existing drug delivery methods, including better effect, less pain for the patient and lower costs.
The central nervous system CNS which integrates the information it receives from all parts of the body is perhaps the most sensitive organ we have. As toxic compounds are able to disturb brain function enormously the brain is separated from circulating blood by a highly selective permeability barrier known as the blood-brain barrier. However the downside of this protection is that 98 percent of all drugs targeting the CNS cannot pass the barrier. Junior professor Dr. Winfried Römer from the BIOSS Centre for Biological Signalling Studies at the University of Freiburg is studying cellular transport mechanisms for their ability to transport drugs across the blood-brain barrier in a non-invasive way.
Chrystelle Mavoungou is a chemist who teaches regulatory affairs and quality in pharmaceutical production at the Biberach University of Applied Sciences’ Faculty of Biotechnology. While the public might consider these issues difficult to deal with, students and early career pharmaceutical biotechnologists quickly learn that issues like these take them right to the heart of the drug discovery process.
The blood-brain barrier prevents most drugs, and large biologics in particular, from entering the brain. This physiological barrier impairs the study of central nervous system (CNS) diseases such as Alzheimer’s, Parkinson’s and multiple sclerosis as well as the development of drugs. However, there is a hidden side entrance to the brain, which means that there is a way to circumvent this barrier.
A remedy is now available for people suffering from dry eye disease. Novaliq GmbH, a specialty pharmaceuticals company from Heidelberg, has developed a highly innovative technology platform for producing innovative drugs to eliminate common eye conditions that cause itching, burning and a feeling of pressure on the eye. The new drug delivery platform not only opens up groundbreaking new prospects for ophthalmology, but also for dermatology.
Drops are a common way of applying drugs for treating a wide of range of eye diseases. Most of us have used eye drops at least once in our lives, but we are not usually aware that even if the drops are applied correctly, only one percent of the drug reaches the eye. The rest is flushed out by eyelid movement or with tear fluid. So very high drug concentrations are needed, and the downside of this is that it can cause substantial adverse effects. Research teams from the Universities of Tübingen and Groningen (Netherlands) have joined forces in a project called “nano-I-drops” and have developed DNA nanoparticles with a high affinity to the cornea, thus improving compliance and making most standard eye drugs more effective.
Boehringer Ingelheim is an important contract manufacturer of biopharmaceuticals that also produces proprietary drugs. We spoke with Dr. Joanne van Ryn, a Canadian pharmacologist who has been doing research at Boehringer Ingelheim’s company site in Biberach for over 20 years. Her research focuses on thrombosis, haemostasis and coagulation. She is involved in the scientific monitoring of dabigatran (Pradaxa), an oral anticoagulant that, in 2008, was granted marketing authorisation for the prevention of venous thromboembolism following orthopaedic surgery.
Polyhydroxyalkanoates (PHA) are biodegradable biopolymers that are becoming increasingly important. Bioplastics are now used not only in everyday objects such as plastic bags and yogurt pots but also increasingly in the field of medicine, which is why intensive research into medical devices made from biodegradable polymers such as PHA has been going on for quite some time.
Pharmaceutical and biotechnology companies are working intensively on the discovery and development of new drugs for the efficient and safe treatment of diseases. However, before drugs are authorised for treating humans and animals, they have to be made into a form that is acceptable. That is where a company called Catalent Pharma Solutions, with a facility in Schorndorf in the south of Germany, comes in.
Peptide- and protein-based drugs like those used for treating diabetes, cancer and autoimmune diseases cannot be administered orally. This is because these biomolecules degrade in the gastrointestinal tract, thus preventing them from reaching their target site in the body. Protein- and peptide-base drugs therefore have to be administered by way of injection, which is comparatively complicated and painful. However, a start-up company called Heidelberg Delivery Technologies GmbH has now developed an innovative technology that makes taking medicines as easy as eating gummy bears.
There are many medications for treating central nervous system diseases. However, only a fraction of the active pharmaceutical ingredients actually reaches the site where they are needed. The reason for this is the blood-brain barrier that protects the brain and thus prevents many drugs used to treat neurological diseases from effectively penetrating the brain. Researchers from the Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB are part of the international N2B-patch consortium that is developing a drug delivery technology for treating multiple sclerosis that enables the active ingredient to reach the brain directly via the nasal mucosa.
Bacteria have developed a versatile defence system to protect themselves against viral infections. One of these defence tools, known as CRISPR/Cas9 system, is currently hogging the headlines as it promises to revolutionise the way genetic material can be modified. Prof. Rolf Backofen from the Institute of Bioinformatics at the University of Freiburg has managed to classify the defence system of all bacterial species sequenced to date. This will certainly facilitate the search for a new generation of powerful genetic engineering tools.
A sophisticated reservoir that sits under the skin and dispenses precise quantities of drugs locally and at a particular point in time now exists. A junior research group from the University of Freiburg’s BrainLinks-BrainTools excellence cluster led by Dr. Maria Asplund and her doctoral student Christian Böhler from the Department of Microsystems Engineering (IMTEK) has developed a small storage system made of organic-inorganic hybrid material that can be implanted and used for the controlled release of pharmaceutical substances.
Secondary hop compounds appear to have a positive effect on the immune system and therefore have the potential to be used for the treatment and prevention of cancer. However, the bioavailability of hop compounds in the human body is relatively poor. Researchers from Hohenheim and Tübingen are therefore looking for a way to increase their absorption rate.
An early phase clinical study involving thirty-six Huntington’s disease (HD) patients is currently underway to investigate whether a method called gene silencing can cure the disease. If the gene that causes the disease can be turned off, it would be the first step towards a treatment that not only fights symptoms but actually treats the causes of HD, hence providing a cure.
Novaliq GmbH, a drug delivery company focusing on difficult to dissolve substances for ophthalmic and dermatological applications, announced the conclusion of a round of financing talks resulting in €3.9 million.
Anyone attempting to assess the importance of pharmacogenetics for drug safety will inevitably end up considering the ambiguous responses of Radio Eriwan. It is true that genetic tests are theoretically able to predict whether an inactive enzyme affects the metabolism of a drug and whether it is necessary to apply a different drug dose. But how can this knowledge be applied in everyday clinical settings when patients with this inactive enzyme are taking three more drugs at the same time that are metabolised through the very same enzymatic pathway?
The University of Tübingen is optimising its drug development pipeline. The TuCADD consortium provides professional help to people who want to take potential drug candidates to clinical application. The coaching involves assistance with the entire phase I drug development phase from industry experts.
Signatope is a new biotech company that has been offering innovative biomarker assays for application in drug discovery since August 2016. The company’s assays can be used in all phases of drug development to detect potential adverse drug effects on the kidneys, liver and other organs in any species whatsoever using minute amounts of sample.
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.
A consortium of two universities two applied research institutes and a research-based pharmaceutical company is looking for innovative cellular models of the human heart with the aim of developing better methods for drug testing.
Nycomed has announced encouraging results from a preliminary analysis of four Phase III trials of Daxas roflumilast in the treatment of symptomatic COPD. The application for marketing authorisation of the drug is expected for 2009.
Hardware and software applications have become an integral part of the everyday life of life sciences researchers, developers and service providers. It is impossible to imagine life science applications without effective hardware and software applications – from computer-assisted drug screening to the automatic production of biosensors for rapid, mobile, purse-size bacterial test devices. Trends such as automation and miniaturisation lead to ever smaller and more independent devices. Will machines soon replace humans?
New pharmaceuticals are subject to approval by drug authorities. Prior to approval of a new pharmaceutical several hurdles such as preclinical and clinical studies need to be cleared. Clinical trials are performed to ensure the quality efficacy and safety of a medicinal product. Clinical development is a time-consuming and costly process and takes on average ten to fifteen years before a pharmaceutical company can apply for the approval of the drug. The costs including failures can amount to approximately one billion US dollars per drug.