About - theraCell

Company

Theracell Advanced Biotechnology is a leading biotechnology company based in Greece. Established in 2013, it specializes in the development of innovative cellular and gene therapy products and is involved in the commercialization of a diverse pipeline of Cell and Gene Therapy (CGT) products. The company’s therapeutic portfolio spans the areas of Orthopedics, Dermatology, Nephrology, Immuno-Oncology, and Tissue Repair and Regeneration.

Through strategic partnerships Theracell Advanced Biotechnology participates in the global vision of the realization of Personalized Medicine tailored to individual patient needs. In 2020 the formation of its key partnership with Orgenesis (www.orgenesis.com), became the basis for expansion of the therapeutic pipeline, with novel cell and gene therapy products developed using tailored processes to meet patients’ needs.

Advanced Therapy Medicinal Products (ATMP)

Advanced Therapy Medicinal Products (ATMP) are comprised of gene therapy, somatic cell therapy and tissue engineered products. Based on viable cells or tissues, their pharmacological, immunologic or metabolic action should be considered as the principal mode of action, as described in Regulation (EC) No 1394/2007 and Directive 2001/83/EC (add link to the regulation and directive).

ATMP is a therapeutic category that offers cures to diseases that otherwise have no known treatment and the products are very different from the treatments offered traditionally. They usually take the form of personalized therapies, designed and executed on a per patient basis, and have the potential to achieve life-changing effects by transforming disease outcome.

Types of ATMPs

Gene Therapy Medicinal Products (GTMP)

Tissue Engineered Products (TEP)

Somatic Cell Therapy Medicinal Products (sCTMP)

Combined ATMPs

ATMPs have long term value for the patient, society and health authorities and their ultimate goal is to safeguard public health. To support timely patient access to these therapies, regulatory authorities have established adjusted authorization and approval pathways that expedite the procedures to make these innovative products available to patients safely.

ATMP research and development and commercialization processes must comply with the legislation governing the medicine development process, including good manufacturing practice (GMP), good clinical practice (GCP) and good laboratory practice (GLP) requirements.

Theracell has a strong vocation for designing and pre-clinically and clinically developing the highest quality ATMP products, and actively participating in the new era of personalized regenerative medicine.

Headquarters

27 Evrota Street

145 64 Kifissia

GREECE

Laboratories

1 Apollonos St. Parodos, Industrial Zone

194 00 - Koropi

GREECE

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