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result(s) for
"Bittorf, Patrick"
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From Single Batch to Mass Production–Automated Platform Design Concept for a Phase II Clinical Trial Tissue Engineered Cartilage Product
2021
Advanced Therapy Medicinal Products (ATMP) provide promising treatment options particularly for unmet clinical needs, such as progressive and chronic diseases where currently no satisfying treatment exists. Especially from the ATMP subclass of Tissue Engineered Products (TEPs), only a few have yet been translated from an academic setting to clinic and beyond. A reason for low numbers of TEPs in current clinical trials and one main key hurdle for TEPs is the cost and labor-intensive manufacturing process. Manual production steps require experienced personnel, are challenging to standardize and to scale up. Automated manufacturing has the potential to overcome these challenges, toward an increasing cost-effectiveness. One major obstacle for automation is the control and risk prevention of cross contaminations, especially when handling parallel production lines of different patient material. These critical steps necessitate validated effective and efficient cleaning procedures in an automated system. In this perspective, possible technologies, concepts and solutions to existing ATMP manufacturing hurdles are discussed on the example of a late clinical phase II trial TEP. In compliance to Good Manufacturing Practice (GMP) guidelines, we propose a dual arm robot based isolator approach. Our novel concept enables complete process automation for adherent cell culture, and the translation of all manual process steps with standard laboratory equipment. Moreover, we discuss novel solutions for automated cleaning, without the need for human intervention. Consequently, our automation concept offers the unique chance to scale up production while becoming more cost-effective, which will ultimately increase TEP availability to a broader number of patients.
Journal Article
Preparation of Phosphorescent Eu2+, Dy3+‐Doped Strontium Aluminate Nanoparticles by Laser Vaporization for the Modification of Therapeutic Contact Lenses
by
Bittorf, Patrick
,
Schweizer, Stefan
,
Dembski, Sofia
in
Biological clocks
,
Contact lenses
,
laser ablation
2022
Biologically, effectively regulated light with a wavelength of about 485 nm can support physiological processes in the body and has a positive impact on the human sleep–wake rhythm. However, the application of common light therapy devices is not always practicable and sometimes difficult to integrate into everyday life. Here, miniaturization of therapy devices, for example, in the form of contact lenses, can reduce the handling disadvantages. Especially, contact lenses modified with phosphorescence materials offer this benefit. Herein, a method to prepare phosphorescent Eu2+, Dy3+‐doped strontium aluminate nanoparticles (NPs) by laser vaporization of macroscopic Eu2+, Dy3+‐doped Sr4Al14O25 particle powder and their integration into polymer‐based contact lenses is provided. NPs with a diameter of about 34 nm emit light in the desired therapeutic wavelength region. These novel NPs are biocompatible and do not show any negative effects during the testing of eye irritation safety in a 3D in vitro cornea model. Phosphorescent lanthanide‐doped strontium aluminate nanoparticles (NPs) are prepared by laser vaporization of a macroscopic powder and integrated into contact lenses to apply for the light therapy of winter depression or sleep disorders. Novel NPs are biocompatible and do not show any negative effects during the testing of eye irritation safety in a 3D in vitro cornea model.
Journal Article