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How we make cell therapy in Italy.

Montemurro T, ViganĂ² M, Budelli S, Montelatici E, Lavazza C, Marino L, Parazzi V, Lazzari L, Giordano R - Drug Des Devel Ther (2015)

Bottom Line: In the 21st century scenario, new therapeutic tools are needed to take up the social and medical challenge posed by the more and more frequent degenerative disorders and by the aging of population.The recent category of advanced therapy medicinal products has been created to comprise cellular, gene therapy, and tissue engineered products, as a new class of drugs.Our hospital took up the challenge of this new path in the early 2000s; and herein we describe the approach we followed to set up a pharmaceutical-grade facility in a public hospital context, with the aim to share the solutions we found to make cell therapy compliant with the requirements for the production and the quality control of a high-standard medicinal product.

View Article: PubMed Central - PubMed

Affiliation: Cell Factory, Unit of Cell Therapy and Cryobiology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.

ABSTRACT
In the 21st century scenario, new therapeutic tools are needed to take up the social and medical challenge posed by the more and more frequent degenerative disorders and by the aging of population. The recent category of advanced therapy medicinal products has been created to comprise cellular, gene therapy, and tissue engineered products, as a new class of drugs. Their manufacture requires the same pharmaceutical framework as for conventional drugs and this means that industrial, large-scale manufacturing process has to be adapted to the peculiar characteristics of cell-containing products. Our hospital took up the challenge of this new path in the early 2000s; and herein we describe the approach we followed to set up a pharmaceutical-grade facility in a public hospital context, with the aim to share the solutions we found to make cell therapy compliant with the requirements for the production and the quality control of a high-standard medicinal product.

No MeSH data available.


Related in: MedlinePlus

Summary of all the steps to be followed for the cell therapy translational process from the bench to the bedside.Abbreviations: GMP, good manufacturing practice; QC, quality control; SOP, standard operating procedure.
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f4-dddt-9-4825: Summary of all the steps to be followed for the cell therapy translational process from the bench to the bedside.Abbreviations: GMP, good manufacturing practice; QC, quality control; SOP, standard operating procedure.

Mentions: A kind of roadmap is summarized in Figure 4. Briefly, there is an important and initial phase of planning where the GMP staff has to carefully analyze preclinical data before moving into a GMP process. Soon after, crucial is the identification of GMP reagents and the development of appropriate SOPs. At the QC level it is mandatory to establish precise and well-defined assays and parameters, providing that any method and results consistently fulfil particular quality requirements. Next, there is the step of validation that must normally be completed for the authorization of the cell therapy production by the QP.


How we make cell therapy in Italy.

Montemurro T, ViganĂ² M, Budelli S, Montelatici E, Lavazza C, Marino L, Parazzi V, Lazzari L, Giordano R - Drug Des Devel Ther (2015)

Summary of all the steps to be followed for the cell therapy translational process from the bench to the bedside.Abbreviations: GMP, good manufacturing practice; QC, quality control; SOP, standard operating procedure.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4548721&req=5

f4-dddt-9-4825: Summary of all the steps to be followed for the cell therapy translational process from the bench to the bedside.Abbreviations: GMP, good manufacturing practice; QC, quality control; SOP, standard operating procedure.
Mentions: A kind of roadmap is summarized in Figure 4. Briefly, there is an important and initial phase of planning where the GMP staff has to carefully analyze preclinical data before moving into a GMP process. Soon after, crucial is the identification of GMP reagents and the development of appropriate SOPs. At the QC level it is mandatory to establish precise and well-defined assays and parameters, providing that any method and results consistently fulfil particular quality requirements. Next, there is the step of validation that must normally be completed for the authorization of the cell therapy production by the QP.

Bottom Line: In the 21st century scenario, new therapeutic tools are needed to take up the social and medical challenge posed by the more and more frequent degenerative disorders and by the aging of population.The recent category of advanced therapy medicinal products has been created to comprise cellular, gene therapy, and tissue engineered products, as a new class of drugs.Our hospital took up the challenge of this new path in the early 2000s; and herein we describe the approach we followed to set up a pharmaceutical-grade facility in a public hospital context, with the aim to share the solutions we found to make cell therapy compliant with the requirements for the production and the quality control of a high-standard medicinal product.

View Article: PubMed Central - PubMed

Affiliation: Cell Factory, Unit of Cell Therapy and Cryobiology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.

ABSTRACT
In the 21st century scenario, new therapeutic tools are needed to take up the social and medical challenge posed by the more and more frequent degenerative disorders and by the aging of population. The recent category of advanced therapy medicinal products has been created to comprise cellular, gene therapy, and tissue engineered products, as a new class of drugs. Their manufacture requires the same pharmaceutical framework as for conventional drugs and this means that industrial, large-scale manufacturing process has to be adapted to the peculiar characteristics of cell-containing products. Our hospital took up the challenge of this new path in the early 2000s; and herein we describe the approach we followed to set up a pharmaceutical-grade facility in a public hospital context, with the aim to share the solutions we found to make cell therapy compliant with the requirements for the production and the quality control of a high-standard medicinal product.

No MeSH data available.


Related in: MedlinePlus