التفاصيل البيبلوغرافية
| العنوان: |
Manufacturing atmps under GMP regulation in an academic institution: a ten years' history of success. |
| المؤلفون: |
Peña-Hernandez, A.1 (AUTHOR), Aguilar, E.1 (AUTHOR), Lora, F.1 (AUTHOR), Mata, R.1 (AUTHOR), Carmona, G.1 (AUTHOR) |
| المصدر: |
Cytotherapy (Elsevier Inc.). 2020 Supplement, Vol. 22, pS141-S141. 1p. |
| مصطلحات موضوعية: |
*CLINICAL trials monitoring, *EXPERIMENTAL design, *MEDICAL care, *MANUFACTURING cells, *MANUFACTURING processes, *INSULIN aspart, *PRODUCTION engineering |
| مصطلحات جغرافية: |
ANDALUSIA (Spain) |
| مستخلص: |
Looking forward setting Andalusia as a reference in the Advanced Therapies field, the Andalusian Network for the Design and Translation of Advanced Therapies (AND&TAT), an academic institution which promotes and coordinates the activities of advanced therapy research, development, innovation and hospital use, being carried out within the Andalusian Public Health System We are part of the Andalusian Public Healthcare System which offers complete health services to about 8.5 million people and comprises, among other infrastructures, 47 hospitals, around 1,500 primary care centers, several research centers and institutes, a network of 10 GMP facilities to manufacture cell and gene therapies and tissue engineering products. Our area of expertise ranges from the preparation of the preclinical evidence to justify the start of a clinical trial through the adaptation of the manufacturing process to comply with GMP regulation, the clinical trial design and monitoring, to the identification of strategic associates for industrial development. At AND&TAT we have developed and currently coordinate a network of 10 GMP facilities focused on validation and manufacturing of Advanced Therapy Medicinal Products (ATMPs) according regulation and training purposes. In which the aim is to promote and facilitate their clinical translation into patients, working closely with Spanish regulators and any other regulatory bodies that can be involved in EU. Since our creation date, we have included more than 1000 patients thanks to their participation in our sponsored 26 clinical trials or under compassionate use in a wide variety of therapeutic areas ranging from cardiology to neurology (Figure 1). As a conclusion: Nowadays the AND&TAT is a reference above Europe in ATMPs in which different collaborators abroad (public and private) has been involved. As a result of over 10 years of experience we dispose a broad portfolio of ATMPs manufactured in our GMP network (Figure 2). [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
Academic Search Index |
