geoscience.net logo
+ Resolve Article
+ Follow Us
Follow on FacebookFollow on Facebook
Follow on TwitterFollow on Twitter

+ Translate
+ Subscribe to Site Feed
GeoScience Most Shared ContentMost Shared Content

Regulatory challenges in manufacturing of pancreatic islets


, : Regulatory challenges in manufacturing of pancreatic islets. Transplantation Proceedings 40(2): 424-426

At the present time, transplantation of pancreatic islet cells is considered an experimental therapy for a selected cohort of patients with type 1 diabetes, and is conducted under an Investigational New Drug (IND) application. Encouraging results of the Edmonton Protocol published in the year 2000 sparked a renewed interest in clinical transplantation of allogeneic islets, triggering a large number of IND applications for phase I clinical trials. Promising results reported by a number of centers since then prompted the Food and Drug Administration (FDA) to consider the possibility of licensing allogeneic islets as a therapeutic treatment for patients with type 1 diabetes. However, prior to licensure, issues such as safety, purity, efficacy, and potency of the islet product must be addressed. This is complicated by the intricate nature of pancreatic islets and limited characterization prior to transplantation. In this context, control of the manufacturing process plays a critical role in the definition of the final product. Despite significant progress made in standardization of the donor organ preservation methods, reagents used, and characterization assays performed to qualify an islet cell product, control of the isolation process remains a challenge. Within the scope of the FDA regulations, islet cells meet the definition of a biologic product, somatic cell therapy, and a drug. In addition, AABB standards that address cellular therapy products apply to manufacturing facilities accredited by this organization. Control of the source material, isolation process, and final product are critical issues that must be addressed in the context of FDA and other relevant regulations applicable to islet cell products.

US$19.90

PMID: 18374089

DOI: 10.1016/j.transproceed.2008.01.027


Other references

Hays, S.A., 2015: Enhancing Rehabilitative Therapies with Vagus Nerve Stimulation. Pathological neural activity could be treated by directing specific plasticity to renormalize circuits and restore function. Rehabilitative therapies aim to promote adaptive circuit changes after neurological disease or injury, but insufficient or...

Kim, J.H.on; Beeler, J.A.; Vezina, P., 2000: Group II, but not group I, metabotropic glutamate receptors in the rat nucleus accumbens contribute to amphetamine-induced locomotion. Recently, it was reported that blocking metabotropic glutamate receptors (mGluRs) in the rat nucleus accumbens (NAcc) prevents the generation of locomotion by amphetamine (AMPH) in this site. In these studies, the non-selective group I/group II mG...

Hingorani K., 1973: Double blind study of benorylate and ibuprofen in rheumatoid arthritis. Rheumatology & Rehabilitation SUPPL: 39-47

Xie, J.; Qian, L.; Hamm Alvarez, S.F.; Mircheff, A.K., 2002: Effect of EGF Stimulation on Protein Sorting in Lacrimal Gland Acini. Purpose: Ocular surface trauma may elicit increased paracrine epidermal growth factor (EGF) signaling in the lacrimal gland. In the course of studies of the traffic of endocytosed (125I)-EGF in lacrimal acini (Xie et al., Cornea 19: S137, 2000), w...

Fischer, B.; Burtch, L.; Kukas, R., 1974: From research results to field performance--why the gap?. Journal of the American Society of Sugar Beet Technologists: 18 (2) 136-141

Swieboda, P.; Filip, Rł.; Prystupa, A.; Drozd, M., 2015: Assessment of pain: types, mechanism and treatment. Pain is the most common symptom of disease, which accompanies us from an early age. It is a protective mechanism to which the body responds to harmful stimulus. The definition of pain states that it is a subjective sensory and emotional experience...

Gee, V.; Vasanthan, T.T.melli, F., 2007: Viscosity of model yogurt systems enriched with barley o-glucan as influenced by starter cultures. The effect of barley o-glucan (BG) on the growth of two yogurt starter cultures (SCs) each consisting of Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus was investigated. Model yogurt systems were prepared with or withou...

Anonymous, 2016: Correction: Targeting of a Transporter to the Outer Apicoplast Membrane in the Human Malaria Parasite Plasmodium falciparum. NlmCategory="UNASSIGNED">[This corrects the article DOI: 10.1371/journal.pone.0159603.].

Zeichner David M.; Macdougall M.; Davis A.; Slavkin H., 1991: Protein kinases in odontogenesis. Journal of Dental Research 70(SPEC ISSUE APRIL): 370

Paeslack, V., 1966: The clinical aspects of paraplegia. Deutsche Schwesternzeitung 19(12): 534-535