TRENDSETTING MEDICAL DEVICES: SOLYPLUS MAKES BIOPOLYMERS INDUSTRY READY

Smart materials revolutionizing cosmetics and medical technology

Smart materials are intelligent, controllable materials with exceptional mechanical, chemical, or pharmacological properties. These materials are playing an increasingly major role in the development of a wide range of innovative and versatile products, and biopolymers are particularly important in the process.

In 2022, SPRIND assigned SolyPlus GmbH to validate its technology so it could explore its disruptive innovation potential. With its recently completed validation process, SolyPlus’ technology makes it possible to transform biopolymers, such as hyaluronic acid or chitosan, into smart materials in pure form. These can be used as starting materials for new, innovative products in regenerative medicine and drug delivery.

By utilizing various technologies, products could be manufactured from pure hyaluronic acid, which, among other components, forms an important component of human connective tissue. Since natural biopolymer is already present in the human body, undesirable reactions, like inflammatory reactions, are more avoidable.

Hyaluronic acid as well as chitosan are naturally occurring macromolecules and could potentially be used in cosmetics, medical technology, and pharmaceuticals. Hyaluronic acid, for example, is non-toxic, non-immunogenic, non-allergenic, and completely degradable in human tissue, making it unlikely to cause any undesirable side effects. Until now, it has not been possible to produce pure hyaluronic acid in a way that it can be shaped in its pure form. This means that the potential applications have fallen far short of the substance-related potential.
SolyPlus

SolyPlus transforms biopolymers into a new state

During the SPRIND validation process, which lasted until spring 2023, SolyPlus analyzed the technology regarding its rheological properties, i.e., those relating to deformation and flow behavior. Furthermore, the validation examined the prototypes’ stability, microscopic organization, and sterilizability, thus preparing them for further preclinical and clinical development. The following has been verified:

1. The microscopic structure, preserved by dispersed hyaluronic acid particles in a hydrophobic suspension, has numerous advantages. This naturally results in a material structure on the micrometer scale that turns into a workable material upon contact with water and can be used in modern skin treatments, such as peeling or exfoliation. For example, when macroscopic hyaluronic acid is homogeneously moistened with water, it becomes a gum-like material that can be used for conformal coating. In so doing, microneedles and other sophisticated micrometer-sized structures can be produced in just a few steps.

2. Considering the sensitivity of biomaterials to heat, solvents, and water content, the machining of smart materials can be utilized to make any shape or size through processing methods. For this purpose, different shaping processes, such as additive manufacturing like 3D printing or two-photon polymerization or forming processes like extrusion or injection molding, can be used to significantly expand the application potential.

3. The materials produced by SolyPlus can be sterilized with conventional sterilization processes which consider the sensitive properties of biopolymers and which are typically employed for producing biomedical and medical-grade materials and in processes. For example, high-pressure sterilization developed for food technology achieved excellent results for hyaluronic acid wound dressings. Other processes that need to be modified for sensitive biopolymers are already showing good results.

Thus, the prerequisites for developing production processes for various applications have been met, and now high-quality smart materials can be scaled up together with their respective shaping technologies. A particular advantage is the possibility of using existing production technologies already established in pharmaceuticals and medical device manufacturing.
The technology is simple: Biopolymer powder is moistened and mechanically treated; the resulting “dough” can then be dried, and because it can be easily shaped, the material has the potential to be used in a wide range of applications and products. Hyaluronic pads or scaffolds are a useful and cost-effective addition to current treatment approaches, particularly when dressing poorly healing, extensive, and chronic wounds caused by vascular diseases or diabetes. The pads can be placed directly in the wound, acting as a kind of scaffolding for the patient’s own cells and thereby making it easier for even large wounds to close and heal. Microneedles made of hyaluronic acid can be used, for example, for painless and rapid vaccination or intradermal treatment. Another useful application is in orthopedic implants. Since these implants dissolve in the body in a controlled manner, no follow-up operations are required, like removing inserted metallic fixations. The company from Haselund, in North Frisia near Husum, has already produced and patented corresponding prototypes.

With its networks, SPRIND will support SolyPlus GmbH in its further endeavors: “The production of biopolymers, like pure hyaluronic acid, that can also be shaped into any size and form through scalable manufacturing processes, opens up completely different possibilities in individualized, patient-specific medicine than before,” explains Dr. Ruth Houbertz, Innovation Manager at SPRIND. “SolyPlus is setting important trends which must be swiftly developed to provide every patient with effective medical care and to significantly reduce the costs of treating illnesses and their consequences.”


More about SolyPlus: solyplus.com

Numerous new products made possible with “dry dough”