Abstract
Process chromatography is in widespread use today for the preparation of many biological products and intermediates as defined in the WHO list of essential drugs. These biochemical products include: insulin, proteins isolated from human blood plasma, e.g., albumin, immune serum globulins, coagulation factors, protease inhibitors; enzymes such as urokinase, streptokinase, asparaginase; tetanus and diphtheria toxoids for vaccine manufacture. Recent developments include the application of process chromatography to the purification of more innovative products such as interferon and allergens. Since the end product of the chromatographic process is destined for human administration, usually by injection or infusion the control and operation of the chromatographic system is of the utmost importance. We will discuss the requirements for process water and the preparation of eluent buffers free from pyrogens and bacterial contamination; the maintenance of process sytems in a sterile or sufficiently “clean” state and the regeneration of non-contaminated and contaminated systems; the maintenance and regeneration of separation media and their integrity including gel life length; essential control parameters in column and batch processes and their conversion to system operation; the products of chromatographic systems and their formulation into pharmaceutical products; and the requirements on personnel and operating areas in biological processing by chromatography. These six aspects of process chromatography and its operation will be exemplified in a case study approach of actual processing situations.
- Received October 16, 1981.
- Accepted November 30, 1981.
- Copyright © Parenteral Drug Association. All rights reserved.
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