Histocell S.L. is a leading biopharmaceutical CDMO specializing in regenerative medicine, operating across two main business areas:

1. The development and manufacturing of advanced therapy medicinal products (ATMPs), such as cell therapies and associated biological products (e.g., secretomes and exosomes).

2. The development and production of medical devices and dermocosmetic products.

In both domains, Histocell provides Contract Development and Manufacturing Organization (CDMO) services, offering comprehensive support from process development to commercial-scale manufacturing.

State-of-the-Art Facilities and Strategic Location

Histocell´s facilities are located in the Basque Country, a vibrant European biotechnology hub in the north of Spain. These facilities support both ATMP and secretomes/exosomes production as well as medical devices and dermocosmetic products production.

Key features of ATMP and secretomes/exosomes production facilities:

• European manufacturer authorization number (MIA: 4269E) and certificate of GMP compliance: authorized for manufacturing cell therapies, biotechnology products (secretomes/exosomes) and immunological products.
• Grade B production rooms designed and equipped for the manufacturing of both autologous and allogeneic therapies, supporting small-scale and large-scale processes as well as fill & finish.
• Advanced cell banking capabilities, including manufacturing of Master Cell Banks (MCBs), Working Cell Banks (WCBs) and cell stocks.
• Widely implemented logistics for daily shipment of biological tissue samples (source of cells) and delivering final products for clinical use (fresh and cryopreserved).

Specialized Medical Device and Dermocosmetic Facilities:

• Over 600 m² of authorized production areas tailored for medical devices (class I-III) and dermocosmetics.
• Small-scale and industrial-scale production lines for diverse product types, ensuring adaptability for prototypes and market-ready goods.

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Expertise in Cell Therapy Development

Histocell has deep expertise in mesenchymal stem cells (MSC)-based therapies, complemented by capabilities in induced pluripotent stem cells (iPSCs), secretomes/exosomes, and specialized cell types like epithelial cells, chondrocytes, and blood-derived cells. The company has developed cell therapy products based on these cells and reach with some of them phase I-II clinical trials for different indications, both as sponsor and/or manufacturer. Histocell is an EU authorized manufacturer since 2011 and has work for more than 13 years with authorities (AEMPS-EMA) in developing cell therapies for several clinical trials. Based on this experience in cell therapy development, Histocell can manufacture the following products for therapeutic applications:

• Autologous and allogeneic MSCs.
• Induced pluripotent stem cells (iPSCs).
• Biotechnology products: secretomes and exosomes.
• Immunological products
• Sterile products for therapeutic applications.
• Cell banks (MCBs and WCBs).
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CDMO services for advanced therapies, medical devices and dermocosmetics

Histocell offers a wide range of services to meet the needs of its clients:

1. Process development and optimization: enhancing workflows for maximum efficiency and scalability.

2. Analytical method development and validation: ensuring product quality and regulatory compliance. In house QP release.

3. Manufacturing services: from clinical-grade intermediates to final products, including sterile fill & finish conditions. Tailored formulations for professional and home care applications.

4. Cell banking and cryopreservation: long-term storage solutions for cells and other products.

5. Complete regulatory support