1979
DOI: 10.1097/00007890-197910000-00007
|View full text |Cite
|
Sign up to set email alerts
|

Manufacture of Antithymocyte Globulin (Atgam) for Clinical Trials

Help me understand this report

Search citation statements

Order By: Relevance

Paper Sections

Select...
2
1
1

Citation Types

0
11
0

Year Published

1984
1984
2005
2005

Publication Types

Select...
7
1

Relationship

0
8

Authors

Journals

citations
Cited by 16 publications
(11 citation statements)
references
References 0 publications
0
11
0
Order By: Relevance
“…Before release for clinical use, ATG products are tested for antibodies that bind to red cells, platelets, human serum protein, and glomerular basement membrane [22]. Nevertheless, antibodies with affinity for platelets and red cells have been identified in some ATG preparations [23].…”
Section: Introductionmentioning
confidence: 99%
“…Before release for clinical use, ATG products are tested for antibodies that bind to red cells, platelets, human serum protein, and glomerular basement membrane [22]. Nevertheless, antibodies with affinity for platelets and red cells have been identified in some ATG preparations [23].…”
Section: Introductionmentioning
confidence: 99%
“…Such clinical differences have been previously attributed to variation in the product [ 171, although this has not been confirmed [ 181. These discrepancies remain unexplained since quality control, by means of in vitro criteria, is employed during manufacture [33], despite which variations in biologic activity and antibody level may exist or occur subsequently during shipping or storage. However, we did not personally assay any of the batches and depended on control of production by the supplier, the delivery of material under ideal transport condition at 4"C, and use shortly after receipt.…”
Section: Discussionmentioning
confidence: 99%
“…Specific activities (cytotoxic activity/concentration) of the dif ferent types of ATG vary: the 'lymphoglobuline' (Institut Mérieux) has a specific activity 4 times great er than that of traditional antilymphocyte sera [18]. The ATG prepared in Mexico has a 50% E-rosette in hibition activity at 1.5 pg/ml, with a 50% antibodydependent cellular cytotoxicity activity at 62.5 ng/ml; indirect immunofluorescence detects equine immu noglobulins attached to human lymphocytes in a dilu tion of 1:160,000 [12], According to these data, this high-potency ATG was used in lower doses (mg/kg) than those recommended by the manufacturers of other types of ATG, for the domestic ATG proved to have a specific activity at least 10 times greater than those of other sources of ATG (40 times greater than that of Upjohn, USA, and 10 times greater than that of Institut Merieux, France [12,18,19]). …”
Section: Discussionmentioning
confidence: 99%