BACKGROUND

At Small New World Laboratories we offer outstanding research and manufacturing expertise for technology development and therapeutic application of extracellular vesicles.

Distinctive advantages provided by the established pilot-scale GMP laboratory infrastructure in Salzburg (Austria) are the possibility for production of therapeutics in a pharmaceutical environment with accompanying GMP-compliant documentation, the focused development of cell-based and cell-free therapeutic approaches, and the joint implementation of research and development services in clinical research projects.

Over the past five years, a strong and interlinked translational research center (EV-TT) was established in Salzburg around the activities of Dr. Rohde & Dr. Gimona that has gained international recognition for its unique combination of expertise in pharmaceutical manufacturing and the development of innovative therapeutics from human source material.

OBJECTIVES

Extracellular vesicles (EVs) represent unique communication systems between cells and tissues that can transfer bioactive and regeneration-supporting cargo to modulate cell behavior and physiology in the target cell. EV-based Next Generation Biologics will eliminate the current shortcomings of traditional stem cell therapies regarding personalization, dosing and unexpected side effects. Small New World Laboratories capitalizes on over 10 years of experience in GMP manufacturing of therapeutic cells and cell-derived vesicles to develop innovative technologies required for the future therapeutic application of EVs. Small New World Laboratories focuses on the synchronized development of manufacturing processes and analytical methods for the establishment of EV-based therapeutics.

Successful therapy development requires the implementation of stringent and robust characteriziation methods to ensure safety and efficacy. Yet, the pharmaceutical industry for cell-based medicines cannot yet draw on a wealth of experience. However, for the EVs therapeutics field, new developments exceed the current technological possibilities of characterization, making analytical technologies a limiting factor in the development and clinical testing of new EV-based therapeutic preparations.

Small New World Laboratories manufactures off-the-shelf biopharmaceuticals based on multipotent stromal cell (MSC)-derived Extracellular Vesicles (EVs) that harbor bioactive molecular cargo and that exhibit positive therapeutic effects in tissue repair and remodeling, mostly via mechanisms of immune modulation and modification of mechanotransduction and aims to develop new analytical technologies to enhance the therapeutic use of extracellular vesicles.