HISTOCELL S.L. | Cell Therapy, Exosomes & Secretomes

Spain Europe

HISTOCELL S.L. | Cell Therapy, Exosomes & Secretomes

Histocell is a Spanish CDMO that develops and manufactures cell therapies from iPSCs, MSCs, secretomes, exosomes and other type of cells, as well medical devices and dermocosmetics.

About the plant

HISTOCELL SITE

Histocell S.L. is a biopharmaceutical company specializing in the field of regenerative medicine, engaged in two principal business areas: the development and manufacturing of advanced therapy medicinal products or ATMPs (cell therapies and associated biological products, such as secretomes and exosomes) and the development and production of medical devices and dermocosmetics. In both domains, Histocell provides contract development and manufacturing organization (CDMO) services.

Its CDMO activities for clinical-phase projects are conducted at its facilities in the Basque Country, a leading hub within the life sciences ecosystem. In the field of cell therapy drug development, Histocell possesses a robust track record in the research and development of therapies based on mesenchymal stem cells. Currently, the company s production capabilities have expanded to include multiple cell lines, such as iPSCs, secretomes, and other cell types. Products manufactured by Histocell as a CDMO include:

Autologous and allogeneic mesenchymal stem cells (MSCs)
Other cell types: epithelial cells, chondrocytes, blood cells
Induced pluripotent stem cells (iPSCs)
Cell banks and stocks (Master Cell Banks - MCB and Working Cell Banks - WCB)
Sterile products
Secretomes and exosomes

Histocell S.L. operates within authorized pharmaceutical-grade facilities (MIA: 4269E) specifically equipped for the production of cell-based therapies and derivatives, such as secretomes. These facilities are designed to support all stages of development, from preclinical and clinical phases to commercial-scale manufacturing. The infrastructure includes fully equipped areas for the manufacturing, control, and release of both autologous and allogeneic therapies, as well as GMP-compliant manufacturing rooms tailored for the scaling-up of autologous therapies (with simultaneous processing suites) and allogeneic therapies (designed for large-scale cell banks and stocks). The range of CDMO services offered by Histocell includes:

Process development and optimization
Development and validation of analytical methods
Scaling-up of autologous and allogeneic processes
Manufacturing of intermediate and final clinical-grade products
Cell bank production (MCB and WCB)
Fill & finish operations
Quality control and release services
Storage and cryopreservation solutions

The company follows a common therapeutic approach focused on the protection and regeneration of tissues damaged by oxidative and inflammatory environments. Some of the services offered by Histocell CDMO for medical devices and dermocosmetics include:

Scientific-based manufacturing
Professional-use and home-care products
Cosmeceutical solutions for professional use: dermapens, microneedling, etc.
Sterile medical devices for injectable use: mesotherapy, biorevitalization, etc.
Full process up to CE marking (I-III)

Some of the technologies developed by Histocell S.L., such as Histoessence and Reoxcare, allow us to apply natural antioxidant and regenerative resources to dermocosmetic or medical products manufactured in our facilities. Histoessence technology is based on an exclusive blend of sulfated glycosaminoglycans and dispersed hyaluronic acid, which allows for the recreation and regeneration of the extracellular matrix, inducing collagen and fibronectin synthesis. This creates a mimetic extracellular matrix, forming a three-dimensional network that encompasses all tissues and promotes tissue regeneration.

Reoxcare technology is based on an exclusive mix of natural antioxidant active ingredients, including ascorbic acid and lycopene, among others, which prevent and protect cellular components from free radical-induced damage. It enhances intracellular defense mechanisms and reduces intracellular ROS levels. The development of these technologies has allowed us to create active ingredients applicable to any dermocosmetic or medical product manufactured at our facilities. Some of these active ingredients include Wharton Gel Complex, Reoxderm Liquid, and Reoxderm Cleanse.

Wharton Gel Complex is an advanced cosmetic ingredient with Histoessence technology, composed of natural glycosaminoglycans like hyaluronic acid. It is designed to combat the extracellular matrix deterioration associated with aging. It stimulates skin regeneration by promoting cell migration, the synthesis of key proteins such as collagen and elastin, and supports skin and hair hydration and repair. It is ideal for anti-aging treatments for sensitive skin with loss of firmness and also contributes to hair growth by regulating the hair follicle and restoring the hair cycle. Reoxderm Liquid is a 100% vegan dermocosmetic ingredient, formulated with Reoxcare technology, combining natural antioxidants to neutralize free radicals and manage oxidative stress following aesthetic treatments. It protects, repairs, and regenerates aging skin through its antioxidant action, promoting the formation of healthy tissue and reducing cytokines in damaged environments.

Reoxderm Cleanse is a vegan dermocosmetic ingredient developed with Reoxcare technology to combat acne by regulating sebum production and eliminating up to 99.99% of biofilm and live bacteria from Cutibacterium acnes, the acne-causing bacteria. Its potent antioxidant action neutralizes free radicals, preventing oxidative stress that contributes to biofilm formation. It is ideal for sensitive, combination, or oily skin and is applied topically as an effective and safe acne treatment.

The different lines for manufacturing medical devices and dermocosmetic products are adaptable to small batches, prototypes, and industrial lots. Furthermore, patented and proprietary products are available for the development of new, innovative formulas based on a scientific approach focused on skin rejuvenation and well-being.

Certifications

ISO
EMA (EU GMP)

Activity

Cell therapy derivatives / Secretomes, ATMP (Advanced Therapies), Topical, mucosal and transdermal, FDF / DRUG PRODUCTS, BIOLOGICS, COSMETICS, Skin products, Skin care, Cream / paste manufacturing

Features

Uses: Investigational, Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
Toxicity (OEB classification):
DEA: N/A
BSL: 1, 2
Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and blood forming organs, (C) Cardiovascular system, (D) Dermatologicals, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system
Markets: DIGEMID (Peru), COFEPRIS (Mexico), INVIMA (Colombia), MSPAS (Guatemala), ISP (Chile), FDA (USA), EMA (EU), PMDA (Japan), CDSCO (India), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), Russian Health Authorities

Batch Size / Reactor

Small, Medium, 1 - 100 L

Services

Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Preformulation studies, Clean room rental, R&D, Formulation / Galenic design, Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, ICH Stability studies, Tech transfer, Pilot plant, Formulation mixing, Lyophilization, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Clean room rental, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation

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