Correction to: Preclinical Development of Cell-Based Products: a European Regulatory Science Perspective.

The article [Preclinical Development of Cell-Based Products: a European Regulatory Science Perspective], written by [James W. McBlane, Parvinder Phul, and Michaela Sharpe], was originally published electronically on the publisher's internet portal (currently SpringerLink).

Preclinical Development of Cell-Based Products: a European Regulatory Science Perspective.

Purpose: This article describes preclinical development of cell-based medicinal products for European markets and discusses European regulatory mechanisms open to developers to aid successful product development. Cell-based medicinal products are diverse, including cells that are autologous or allogeneic, have been genetically modified, or not, or expanded ex vivo, and applied systemically or to an anatomical site different to that of their origin; comments applicable to one product may not be applicable to others, so bespoke development is needed, for all elements - quality, preclinical and clinical.

Methods: After establishing how the product is produced, proof of potential for therapeutic efficacy, and then safety, of the product need to be determined.

Near-optimal conditions for the in vitro culture of hemopoietic progenitor cells in bone marrow from the rat.

In vitro techniques for the culture of hemopoietic stem cells and committed hemopoietic progenitor cells in rat bone marrow have not been adequately described in the literature. In the present investigations, and using commercially available hemopoietic cytokines and growth factors, the conditions required to perform long-term bone marrow culture (LTBMC) using rat femoral bone marrow were studied, in conjunction with the colony-forming unit cell assay (CFU-C), to quantify the number of progenitor cells. CFU-C production by LTBMCs, set up using Iscove's modified Dulbecco's medium supplemented with fetal calf serum and horse serum, ceased after week 2 of culture.