Preclinical good laboratory practice-compliant safety study to evaluate biodistribution and tumorigenicity of a cartilage advanced therapy medicinal product (ATMP). [PDF]
Background: The clinical development of advanced therapy medicinal products (ATMPs), a new class of drugs, requires initial safety studies that deviate from standard non-clinical safety protocols.
Zscharnack M +11 more
europepmc +5 more sources
A novel GMP-manufactured medicinal product candidate composed of NK and γδ T cells as adjunct immunotherapy for hematopoietic stem cell transplantation [PDF]
γδ T lymphocytes and NK cells are effective to kill tumors or viral-infected cells avoiding graft versus host disease (GvHD), thus they have attracted high interest as potential tool for adoptive cell therapy.
Fabio Morandi +8 more
doaj +2 more sources
Gene and cell therapy research recently reached a fundamental milestone toward the goal to deliver new medicines for orphan diseases. In 2016, the European Commission granted market approval to GlaxoSmithKline (GSK) for ex vivo hematopoietic stem cell ...
Alessandro Aiuti +2 more
doaj +2 more sources
Improvement of the inactivated SARS-CoV-2 vaccine potency through formulation in alum/naloxone adjuvant; Robust T cell and anti-RBD IgG responses [PDF]
Objective(s): SARS-CoV-2, emerging as a major threat to public health, has to be controlled through vaccination. Naloxone (NLX), an opioid receptor antagonist, demonstrated its adjuvant activity for microbial vaccines. In this study, inactivated SARS-CoV-
Melika Haghighi +3 more
doaj +1 more source
Glucomannan as a Dietary Supplement for Treatment of Breast Cancer in a Mouse Model
Konjac glucomannan (KGM) is a water-soluble polysaccharide derived from the Amorphophallus’s tuber and, as herbal medicine has shown, can suppress tumor growth or improve health.
Nioosha Ahmadi +4 more
doaj +1 more source
Il finanziamento della ricerca clinica in Advanced Therapy Medicinal Products (ATMP): cosa determina l'intervento della Finanza? [PDF]
Il finanziamento della ricerca medica è un prerequisito per migliorare la salute pubblica e l'inclusione sociale ed economica. Tuttavia, la ricerca medica incontra numerosi ostacoli nell’ottenimento di finanziamenti, che sono ancora più rilevanti per ...
Pennetta, D., Gambarelli, L.
core +1 more source
Clinical Applications and Anticancer Effects of Antimicrobial Peptides: From Bench to Bedside
Cancer is a multifaceted global health issue and one of the leading causes of death worldwide. In recent years, medical science has achieved great advances in the diagnosis and treatment of cancer.
Ameneh Jafari +5 more
doaj +1 more source
Cell and Gene Therapy Products (CGT), regulated as Advanced Therapy Medicinal Products (ATMP) in the European Union (EU), represent a novel and varied group of biotherapeutics developed to treat specific conditions for which there are limited or no ...
Laura I. Salazar-Fontana +2 more
doaj +1 more source
Towards novel reimbursement models for expensive advanced therapy medicinal products (ATMPs)
Currently, a major focus of biomedical research and clinical application are the so-called advanced therapy medicinal products (ATMPs), which are highly complex medicines that enable the targeted and personalised treatment of patients. The potential of ATMPs in future cancer treatment is invaluable.
Picecchi, Dario +3 more
openaire +4 more sources
Endotoxin content is a critical factor that affects the safety of biological pharmaceutical products. International pharmacopoeias describe several reference methods to determine endotoxin levels in advanced therapy medicinal product (ATMP) preparations.
Salvatore Pasqua +11 more
doaj +1 more source

