We successfully transduced Fabry patient CD34+ hematopoietic cells with "near-clinical grade" LV/AGA in small-scale cultures and then validated a clinically directed scale-up transduction process in a GMP-compliant cell processing facility.
BV Cyclotron VU in Amsterdam is a private company with a GMP-compliant PET production facility.
The peptides were synthesized in a GMP-compliant qualified area at ABX.
The second phase of the reconstruction (setting up of a GMP-compliant cleanroom) is scheduled to start January 2016, leading to full operability in April 2016 and, upon inspection by the Dutch Inspectorate (IGZ), GMP-compliant production is expected by the end of 2016.
Radiolabelled [11C]HED was synthesized according to a GMP-compliant procedure (licence nr. 108879 F), using a modification of the method of Van Dort and Tluczek [28].
ICNAS is a research unit of the University of Coimbra that hosts a GMP-compliant PET production facility which supports clinical and pre-clinical R&D programs and supplies RPs to nearby hospitals.
In pursuing this goal, we have developed a GMP-compliant scalable process of generating neural stem cells (NSCs) and further differentiate them into dopaminergic neurons in defined conditions from hESCs adapted to a defined medium.
In 2002, Luhm et al. published a GMP-compliant NK cell expansion method using irradiated PBMCs, IL-2, and IL-15 in a closed system [ 70].
In response, the Wellcome Trust and Scottish National Blood Transfusion Service SNBTSS) funded the set up of a GMP-compliant cell bank, which was licenced by the Medicines and Healthcare products Regulatory Agency MHRAA) to start supplying CTLs in February 2012.
RNA is easy and fast to synthesise in a GMP-compliant manner and RNA does not integrate into the host genome, facilitating regulatory hurdles.
We describe the establishment and operation of a GMP-compliant, third-party, EBV-specific CTL bank manufactured under all relevant EC regulation.
