Manufacturing Clinical-Grade Cell and Gene Therapy Products

Name: Manufacturing Clinical-Grade Cell and Gene Therapy Products
Brand: Sudwestdeutscher Verlag Fur Hochschulschriften AG
SKU: 9783838138657
Price: 15814 HUF
Availability: InStock

Economic Implications for Academic GMP Facilities

Szerző: Abou-El-Enein Mohamed

Nyelv:

Kötés: Puha kötésű

Kiadó: Sudwestdeutscher Verlag Fur Hochschulschriften AG

Elérhetőség: Beszállítói készleten

Küldés 8-11 napon belül

15 814 Ft

Advanced therapy medicinal products (ATMP) represents a new class of medicinal products, which inclu...

Információk a könyvről

Szerző

Abou-El-Enein Mohamed

Nyelv

Angol

Kötés

Könyv - Puha kötésű

Kiadva

2014

oldal

EAN

9783838138657

ISBN

3838138651

Enbook ID

09026602

Kiadó

Sudwestdeutscher Verlag Fur Hochschulschriften AG

Súly

127

Méretek

152 x 229 x 5

Teljes leírás

Advanced therapy medicinal products (ATMP) represents a new class of medicinal products, which include - amongst others - somatic cell and gene therapies. As the final product is intended for administration into humans, manufacturers of ATMPs are obligated to apply good manufacturing practice (GMP) standards within their processes. Reaching and maintaining such standards is cost intensive and requires sophisticated manufacturing facilities. As a result, academic researchers who are developing these novel therapeutic approaches are facing new technological and financial challenges. In order to bring more commercially accessible therapies to patients and demonstrate efficient manufacturing technologies, we established the clean-room technology assessment technique (CTAT). CTAT comprises several tools to identify and assign a reliable monetary value to the different operational processes. The model also serves as a guideline for optimizing the operation of an academic GMP facility.

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Manufacturing Clinical-Grade Cell and Gene Therapy Products

Economic Implications for Academic GMP Facilities

Információk a könyvről

Teljes leírás

Érdekelheti

Azok a vásárlók, akik ezt a könyvet megvásárolták, a következőket is megvásárolták