Life Sciences Engineering
Fraunhofer Institute for Production Technology
In the "Life Sciences Engineering" business area, the Fraunhofer IPT researches and develops pioneering technologies for the entire range of life sciences from the pharmaceutical industry and biotechnology to medical technology. As a production engineering research institute, we have many years of in-house experience in production processes, manufacturing techniques, metrological systems, process automation, technology and quality management. We have been applying this expertise effectively and profitably in the life sciences sector.
We assemble interdisciplinary teams comprising engineering, biology and medical experts, who develop customized concepts and technical solutions for the entire process of product development and support our customers through the entire process, from the very beginning of the preliminary research stage through market orientation and ultimately to certification. Our well established network provides us with access to the know-how already acquired by additional scientific facilities in Germany and in the USA: We have particularly close links with the WZL Machine Tool Laboratory of the RWTH Aachen, the Fraunhofer Center for Manufacturing Innovation CMI in Boston and Boston University.
Our activities in this business area are organized in the following sectors:
Production technologies for medical products
New technologies are continuously being applied alongside classical production methods in the medical technology sector to come up with new products. The Fraunhofer IPT develops manufacturing technologies and process chains specifically for the manufacture of surgical instruments and implants.
Design and manufacture of miniaturized fiber reinforced profiles
Our "Micro-Pultrusion" and "Micro-Pullwinding" production processes permit virtually any length of fiber reinforced profile to be manufactured with a diameter of less than 500 µm. In medical engineering, profiles like this can be used anywhere where the electrical properties of metals render these unsuitable yet the mechanical requirements and the demands to be met in terms of functional integration are extremely exacting. This applies, for example, to the operating instruments used in minimally invasive interventions in MRI systems. We process a diverse range of plastics and reinforcing fibers in order to achieve the required mechanical, optical or thermal properties for medical products.
Micro and precision multi-axis milling
The manufacture of anatomically formed titanium bone plates or of carefully crafted ceramic dental inlays customized to suit the individual needs of each patient with a high degree of process reliability is possible only with specially adapted process technology and peripheral technology. We have pooled our expertise with that of specialist companies and suppliers from the medical technology industry to develop efficient milling operations, specially shaped milling tools with optimized cutting edges, cutting strategies for a range of materials and path guidance strategies, which have demonstrated excellent process reliability. We integrate the individual technologies we develop within the manufacturing equipment already in place at the premises of our customers and provide support during the initial stages of production.
Developing and manufacturing components made of fiber-reinforced plastic
Components made of fiber-reinforced plastic are prized for their x-ray transparency, autoclavability, biocompatibility and excellent mechanical properties in diverse fields of medical engineering. We develop both fiber-reinforced composite components and parts made of hybrid material composites for use in medical products. In addition to component design and production, our service includes the qualification of component and laminate qualities. We develop and optimize fiber placement, laser-assisted tape laying, winding and thermoforming for the production of fiber reinforced components and also have many years of experience in hand laminating, in prepreg techniques and in the manufacture of sandwich structures.
Metrological systems for applications in life sciences
Both in bio-technological manufacturing processes and in a number of medical applications, it is vital to measure and evaluate the condition of cells and tissue with a high level of precision. The Fraunhofer IPT develops high through-put processes for recording the condition and assuring the quality of process variables, which can be integrated within automated production equipment. In diagnostic applications, the focus is on non-invasive tomographic imaging.
We develop individual diagnostic systems based on optical coherence tomography (OCT). We recognize the importance of involving the entire development process, leaving no detail out: We construct the measuring modules, implement image processing algorithms and develop customized fiber probes where required. The OCT is already being deployed successfully to automate quality control for artificial skin probes and for morphological diagnostics on chondral tissue. We are also engaged in the design and manufacture of specialized nano-antennae for diagnostic infrared spectroscopy.
Measuring systems for high through-put processes
The Fraunhofer IPT develops measuring technology for laboratory processes – from systems for manual cell culture to automated biotechnological production plant. We integrate commercially available measuring instruments for cellular quality control in automated equipment or develop our own solutions wherever the available systems cannot meet the specified requirements. High-speed microscopy is one example of this. In this case, we have developed a system which achieves a significant increase in the throughput of samples. It can be integrated within the majority of microscopes readily available on the market and achieves a considerable reduction in the amount of time required to microscope a cell culture container.
Handling and characterizing cells
Biological samples of cells and tissue are generally characterized using microscope-based methods. The Fraunhofer IPT is continuing to refine the technique of automated fluorescence microscopy whilst at the same time pursuing new methods such as digital holography for quantitative phase-contrast imaging and single-plane illumination microscopy for certain applications.
Digital holography for quantitative phase-contrast imaging permits 2.5 dimensional images of biological samples to be produced in minimally invasive procedures without the use of markers. Multi-focal optical tweezers permit biological cells to be captured, manipulated and moved. The structured lighting of single-plane illumination microscopy renders this technique suitable for increasing the resolution of fluorescence microscopy.
Automation for laboratory processes
Scientists at the Fraunhofer IPT collaborate closely with biologists and engineers to develop concepts for the automation of laboratory processes – right across the range from individual special-purpose measuring instruments to the automation of complex, biological cell culture processes.
Development of concepts for the automation of laboratory processes
The focus in the analysis and transfer of laboratory processes to concepts for automation is always on the requirements of the customer: However, it is often impossible to transfer biological protocols directly to the automation technology. We therefore combine our engineering and biological know-how and adapt sub-processes step-by-step to the automation function in hand. This process involves not only drawing on established solutions in the form of commercially available equipment and instruments but also developing completely new solutions. This approach allows us to offer our customers a requirement oriented concept which we subsequently adapt to ensure that it fully matches the required protocols. We involve our clients closely at in the concept phase and welcome their input regarding the quality-relevant parameters. Only this close collaboration guarantees that the automation concept takes account of all of the vital requirements.
Integrating instruments in production plants and one-off individual modules
Although there are currently numerous laboratory automation devices on the market, a large number of customer requirements are still not being met. Existing solutions frequently fail to achieve the required throughput, are complex to operate or are over-designed.
For this reason, the Fraunhofer IPT focusses on customized, one-off modules. Individual processes can be partially automated on the basis of the commercially available laboratory instruments supplied by a wide range of manufacturers. Many personnel-intensive handling processes in process steps up or downstream can be replaced by suitable partial automation systems.
Plant automation for life sciences
The Fraunhofer IPT develops solutions for flexible laboratory automation in the form of a modular system. Existing laboratory instruments produced by a range of manufacturers combined with our own innovative developments form the basis for this automation.
The modular construction permits individual solutions to be crafted for the process concerned. The ergonomics of plant operation are crucial in this context. The customer can wield enormous influence starting at the concept development phase. The modular construction system thus offers a high degree of flexibility and can easily be extended by the addition of further components. The new developments can also be integrated in existing equipment and adapted to match additional protocols.
Both documentation and handling can be fully automated. Consequently, the customer can process a range of different protocols depending on the product concerned and reduce the number and/or length of personnel-intensive process steps. The results thereby achieved are replicable – eliminating any disruptive factors and thus contributing to higher product quality, due to the fully automated and therefore repeatable process cycle, irrespective of personnel-based parameters.
Manufacturing technologies for functional micro-structures
The interaction between organisms or cells and technical surfaces plays a major role in the development of products used in life sciences. When suitable production methods are applied, it is possible to generate specific micro-structures, which have a major effect on this interaction. The range of applications extends from structuring implants to micro-structured disposables for cell culture processes to influence proliferation characteristics.
Laser structuring is a material removal process in which short laser pulses are used to vaporize material. The material is then removed in a non-contact, wear-free operation.
This permits structures measuring only a few micrometers to be generated in a range of different surfaces. When the machine axes used to position the component to the part positioning facility are coupled with the optical axes for rapid beam direction, the laser system itself can process large, connected and highly complicated freeform surfaces. The automated procedure is also capable of achieving reproducible results flexibly with a diverse range of designs and structures. Regular structures for tribological applications can be generated as can complex, irregular structures for microfluidic and design applications.
Laser structuring is suitable for virtually all materials: from metallic forming tools for mass production to plastics, ceramics or glass in prototype manufacture. In the case of plastics and glass, process-related chemical changes in the boundary layer can also be prevented. This renders the process particularly suitable for biological and medical engineering applications.
Discrete surface structures can be generated by using diamond tools to perform the machining operation – from sharp edges to rounded structures. Depending on the production operation concerned, surface roughness (Ra) can be in the low, single figure nanometer range and any surface geometry required, ranging from planar surfaces to three-dimensional curved surfaces can be produced. The part size can vary from only a few millimeters to edge length in excess of one meter. The structured surfaces are frequently used as injection molding tools for the replication of disposables and optical components.
Micro-production in three dimensions – small structures with big applications
Two-photon polymerization can be used to produce as many three-dimensional structures in the sub-micron range as required: Whereas the areas of application were previously predominantly in the optics, photonics, sensor systems or micro-fluidics sectors, this new technology is now assuming greater significance in life science engineering. Whether filigree, individually adapted cellular matrices made of various materials, surface structures with an extremely wide range of different geometries or defined, porous membranes, two-photon polymerization can cope with structural designs which were previously inconceivable.
Technology and quality management in life sciences
The medical technology and biotechnology industries are characterized by extremely short product life cycles. In order to configure the product development process and the commercial launch optimally, the Fraunhofer IPT is developing quality and risk management systems specifically for these sectors and provides technical support to companies in the form of market and process analyses.
Development and optimization of quality and risk management systems
In life sciences, the requirements to be met by products and their manufacture are particularly high. In order to meet these requirements and to bring the products reliably and efficiently to market, we develop and optimize individualized quality and risk management systems for companies in the medical engineering and biotechnology sectors. The integrated deployment of established and newly developed quality management methods is crucial in the phase spanning the period from product development to product use as this is the only means of ensuring that risks can be identified and treated at an early stage.
Supporting certification processes
The implementation of quality and risk management systems is a prerequisite for certification in accordance with ISO 13485/14971 or the cGMP. The Fraunhofer IPT provides support in configuring these management systems in accordance with the applicable norms and ensures that our customers meet all statutory and regulatory requirements. This then forms the basis for successful compliance management.
The success of any technology development and market launch, regardless of the sector involved, be it the food industry, the pharmaceutical industry or medical engineering, is dependent largely on customized technology management. We offer advice starting from the technology management planning phase right through to the configuration of the strategies, processes and methods. The future deployment of technologies and products in the life sciences sector can be planned systematically using a stringent, method-based technology road-mapping process. On the basis of trend analyses, for example, we determine specific customer and market requirements in relation to certain technologies and products for life science applications.
In collaboration with our customers, we plan the introduction of the technology to the market. We also present potential technology and expertise-based diversifications. We demonstrate how know-how and technologies can be used to open up new markets or to expand existing markets efficiently. We evaluate the attractiveness of diversification for organizations thus creating a solid basis for the decision-making process.
Increasing procurement volumes in conjunction with the higher levels of complexity and diversity of the products to be sourced, is presenting companies with considerable challenges. In this situation, it is vital to keep track of material costs and to evaluate quotes from various different suppliers in terms of their functionality and quality. We help companies to plan, implement and carry out cost optimization projects and to identify potential for achieving savings in product purchasing.