Human blood derivative

All devices incorporating, as an integral part, a human blood derivative are in Class III. 

A declaration stating whether or not the device incorporates, as an integral part, a substance or human blood derivative, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device... 

Wiliemer, H. Freeze-drying process data determination for human blood derivates with factor VIII as example. PDA Fourth International Congress, p. 142-151, Vienna, 1996. Copyright 1996, PDA Inc. Bethesda, Maryland, USA... 

Degwert, J.S., Hoppe, U. and Kligman, L. H., In vitro model for contact sensitization I. Stimulatory capacities of human blood-derived dendritic cells and their phenotypical alterations in the presence of contact sensitizers, Toxicol, in Vitro, 11,613, 1997. 

Arrighi, J.F.et al., A critical role for p38 mitogen-activated protein kinase in the maturation of human blood-derived dendritic cells induced by lipopolysaccharide, TNF-alpha, and contact sensitizers. J. Immunol., 166, 3837, 2001. 

Human blood or human blood-derived products, including placental blood-derived products, animal-derived procoagulant products and animal- or cell culture-derived hemoglobin-based products intended to act as red blood cell... 

Fig. 1.24.2. Electrical resistance of a human blood derivative. Cooling rate (1)14 and (2) 1 °C/min...

Inorganic membranes have been mentioned in other usage in the biotechnology and pharmaceutical industries. For example, ziiconia and alumina-based ceramic membranes have been incorporated in the following operations [Cueille and Ferreira, 1989] purification and concentration of antibiotics, vitamins, amino-acids, organic acids, enzymes, biopolymers and biopeptides for the fermentation steps in the more conventional applications human blood derivatives, vaccines, recombinant proteins, cells culture and monoclonal antibiotics in newer applications and pyrogen lemoval for ultrapure water. 

To verify the immunogenic potential of the peptides identified via MAPPs, candidate epitopes are routinely screened in a T cell activation assay which involves human blood-derived APCs and autologous T cells from the same blood donor. In comparison to in silico tools described above, MAPPs has several advantages in T cell epitope identification (i) it narrows down the number of potentially relevant epitopes, as predictable by in silico tools, to a few immunodominant epitopes so that the potency of the drug can be retained more easily (ii) it takes into account post-translational modifications of biologies that may change the pattern of relevant epitopes and (iii) it can be done with fully formulated biologies—a feature not covered by any of the other approaches described above. 

Thus, the EU, in particular, develops a series of interpretative guidelines [28] to help manufacturers in the correct implementation of the requirements of Directive 93/42/EEC in particular, the context of MD applies to guideline MEDDEV 2.1/3 MEDICAL DEVICES Guidance document—Borderline products, drug-delivery products and medical devices incorporating, as an integral part, an ancillary medicinal substance or an ancillary human blood derivative. ... 

MEDDEV 2.1/3 MEDICAL DEVICES Guidance document - borderline products, drug-delivery products and medical devices incorporating, as an integral part, an ancillary medicinal substance or an ancillary human blood derivative. 

Boyle JJ, Bowyer DE, Weissberg PL, Bennett MR. Human blood-derived macrophages induce apoptosis in human plaque-derived vascular smooth muscle cells by Fas-ligand/Fas interactions. Arterioscler Thromb Vase Biol 2001 21 1402-1407. 

Cohen, H.C., Joyce, E.J., Kao, W.J. Biomaterials selectively modulate interactions between human blood-derived polymorphonuclear leukocytes and monocytes. Am. J. Pathol. 182, 2180-2190 (2013). doi 10.1016/j.ajpath.2013.02.022... 

Human blood plasma contains over 700 different proteins (qv) (1). Some of these are used in the treatment of illness and injury and form a set of pharmaceutical products that have become essential to modem medicine (Table 1). Preparation of these products is commonly referred to as blood plasma fractionation, an activity often regarded as a branch of medical technology, but which is actually a process industry engaged in the manufacture of speciaUst biopharmaceutical products derived from a natural biological feedstock (see Pharmaceuticals). 

Cellular therapies in transplantation and cancer are based on specific cells separated or sorted from human blood, bone marrow, or cord blood by means of their specific cell surface markers or cell differentiation antigens, e.g., CD3, CD4, CD8, CD 14, CD 19, and CD34. For example, the CD34+ stem cells, especially those derived from human embryos, have the capacity to differentiate in culture to generate different somatic cells, e.g., liver cells, heart cells, neurons, etc. This exploding field of research is now termed regenerative medicine. 

Title VIII Supervision and sanctions Tide X Special provisions on medicinal products derived from human blood and plasma Tide XI Supervision and sanctions... 

EC Amends Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma... 

Annex 12 Use of Ionising Radiation in the Manutacture ot Medicinal Products Annex 13 Manufacture of Investigational Medicinal Products Annex 14 Manufacture of Products derived from Human Blood or Human Plasma Annex 15 Qualification and validation... 

Freedman, M.S., Ruijs, T.C., Selin, L.K., Antel, J.P. (1991). Peripheral blood gamma delta T cells lyse fresh human brain derived oligodendrocytes. Ann. Neurol. 30, 794-800. 

Eisert V, Kreutz M, Becker K, et al. Analysis of cellular factors influencing the replication of human immunodeficiency virus type I in human macrophages derived from blood of different healthy donors. Virology 2001 286(1) 31 44. 

Thiele L, Rothen-Rutishauser B, Jilek S et al (2001) Evaluation of particle uptake in human blood monocyte-derived cells in vitro. Does phagocytosis activity of dendritic cells measure up with macrophages J Control Release 76 59-71... 

Several companies have expressed the cDNA coding for human factor VIII C in a variety of eukaryotic production systems (human VIII C contains 25 potential glycosylation sites). CHO cells and BHK cell lines have been most commonly used, in addition to other cell lines, such as various mouse carcinoma cell lines. The recombinant factor VIII product generally contains only VIII C (i.e. is devoid of vWF). However, both clinical and preclinical studies have shown that administration of this product to patients suffering from haemophilia A is equally as effective as administering blood-derived factor VIII complex. The recombinant VIII C product appears to bind plasma... 

---