CDMO-EN administrador 24/11/2023
THIRD PARTY MANUFACTURING

Your CDMO partner

Histocell is a regenerative medicine biopharmaceutical company CDMO with extensive experience in developing and manufacturing cell-based therapies and novel medical devices.

Spain-based clinical stage CDMO, located in the biohealth ecosystem of the Basque Country.

Together with the Basque Health Cluster, Histocell is part of an innovative cell and gene therapy ATMPs manufacturing hub.

histocell-cdmo-europe
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m2 manufacturing and quality control facilities
What do we manufacture?
  • Autologous and allogeneic mesenchymal stem cells (MSC).
  • Other types of cells: epithelial cells, chondrocytes, blood cells…
  • Induced pluripotent stem cells (iPSC).
  • Cell banks and stocks.
  • Sterile products.
  • Secretomes of different cell types.
  • Exosomes (R&D).
  • CAR-T and NK cells (R&D).
More than 13 years working in close contact with the AEMPS (EMA)
Facilities
  • Authorised pharmaceutical laboratory (MIA: 4269E).
  • Facilities for the manufacture of cell therapy drugs or derivatives, such as secretomes.
  • Designed to carry out development, pre-clinical and clinical phases, and ready to take on the manufacture of drugs that reach the commercial phase.
  • Fully equipped rooms for the manufacture, control and release of autologous and allogeneic therapies.
  • GMP manufacturing rooms for scale-up of autologous therapies (rooms for simultaneous processing) and allogeneic therapies (rooms for large cell banks and stocks), and associated infrastructures.
  • Quality services and procedures for the manufacture of clinical grade material.
7 clean rooms

GMP

Serial rooms

Simultaneous processing

Large banks

MCB & WCB

Services
  • Development and optimisation of processes.
  • Development and validation of analytical methods.
  • Scale-up of allogeneic and autologous processes.
  • Manufacture of clinical grade intermediate and final products.
  • Manufacture of cell banks (stocks).
  • Fill & Finish.
  • Quality control and release.
  • Storage and cryopreservation.
What do we manufacture?
  • Manufacturing based on a scientific approach.
  • Products for professional use and home care.
  • Cosmetic solutions for professional topical use: dermapen, microneedling, …
  • Sterile medical devices for injectable use: mesotherapy, biorevitalisation, …
  • Complete process up to CE marking (I-III).
Facilities that meet your needs
Our facilities
  • More than 600 m2 of approved manufacturing facilities for medical devices and dermo-cosmetic products.
  • Active manufacturing of medical devices for wound care on an international basis.
Production capacity from pilot batches to large industrial batches
Our services
  • Manufacturing lines adapted to small batches, prototypes and industrial batches of medical devices and dermo-cosmetic products.
  • External supplier with great flexibility in development and manufacturing with laboratories under quality control.
  • Proprietary and patented active products available for the development of new innovative formulations.
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