Manufacture of Antithymocyte Globulin (Atgam) for Clinical Trials

Wj, Wechter; Jw, Nelson; Rj, Perper; Aj, Parcells; Kw, Riebe; Js, Evans; Ps, Satoh; H, Ko

doi:10.1097/00007890-197910000-00007

Cited by 16 publications

(11 citation statements)

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“…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%

Acute and Hyperacute Humoral Rejection in Kidney Allograft Recipients Treated with Anti-Human Thymocyte Antibodies

et al. 2005

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Section: Introductionmentioning

confidence: 99%

Acute and Hyperacute Humoral Rejection in Kidney Allograft Recipients Treated with Anti-Human Thymocyte Antibodies

et al. 2005

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“…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%

Treatment of aplastic anaemia with antilymphocyte globulin and high‐dose methylprednisolone

1991

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Twenty-three consecutive adults with bone marrow aplasia who, apart from one individual, lacked a sibling suitable for allogeneic transplantation, received five daily infusions of 50 mg/kg of antilymphocyte globulin (ALG) concurrently with high-dose (500 mg) methylprednisolone (HDMP), followed by oral prednisone at a dose of 30 mg until day 30. One patient died early so that response could not be determined, but data are available and included in the toxicity as well as survival analysis. Haematological response occurred in 13 of the remaining 22 (59%). This followed a single course of treatment in 12, with complete response achieved in five of this group and a second course required in one. At a median follow-up of 20 months (range 5-60), there have been five relapses and 13 patients are alive, including 12 responders who have Karnofsky ratings between 90% and 100%. Of the other nine individuals, only two are alive, with 1 at 12 months still requiring active support and the second, after failing further courses of treatment, at 41 months having a partial response to lymphocytapheresis and plasma exchange. Failure to respond was a significant adverse predictor for survival (P = 0.022). This study involved two distinct batches of ALG, with response occurring in 1/7 (14%) patients treated with the first lot, but in 12/15 (80%) of those individuals who were treated with the second (P = 0.007). Only a pretreatment mean cell volume (MCV) greater than 100 fL predicted for response (P = 0.0088). Confirmation is hereby provided for the efficacy of ALG used in combination with HDMP for treatment of aplastic anaemia, with further support for the observation that not all batches of this product are comparable in bringing about haematologic response in these individuals.

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“…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%

Low Doses of High-Potency Antithymocyte Globulin (ATG) in Severe Aplastic Anemia: Experience with the Mexican ATG

et al. 1989

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Twenty patients with severe aplastic anemia (SAA) were treated with low doses (1–5 mg/kg/day) of a high-potency antithymocyte globulin (ATC) produced in Mexico, shown to have at least a 10-fold potency as compared with other globulins of commercial sources. Patients received ATG within a 10-day period, every other day (5 doses) at a dose of 1 mg/kg/day (4 courses), 2 mg/kg/day (12 courses) or 5 mg/kg/day (8 courses). Four patients received 2 consecutive courses of different doses of ATG. A response rate of 42% was recorded in the group, assessed by means of increases in reticulocytes, granulocytes or platelets. One patient showed a complete remission. The 570-day survival of the group was 51 %. It is concluded that the domestically produced ATG is useful in the treatment of some patients with SAA in Mexico.

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Manufacture of Antithymocyte Globulin (Atgam) for Clinical Trials

Cited by 16 publications

References 0 publications

Acute and Hyperacute Humoral Rejection in Kidney Allograft Recipients Treated with Anti-Human Thymocyte Antibodies

Acute and Hyperacute Humoral Rejection in Kidney Allograft Recipients Treated with Anti-Human Thymocyte Antibodies

Treatment of aplastic anaemia with antilymphocyte globulin and high‐dose methylprednisolone

Low Doses of High-Potency Antithymocyte Globulin (ATG) in Severe Aplastic Anemia: Experience with the Mexican ATG

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