Changes in therapeutic proteins caused by preparation techniques

Article Abstract:

Therapeutic proteins, also called biologicals, are used to treat various conditions characterized by a deficiency of specific proteins, such as immunoglobulins, which are immune system proteins. However, the use of therapeutic proteins has been associated with problems of patient idiosyncrasy, the unusual reaction of a patient to a drug, and product variability, differences in product characteristics due to different preparation techniques. Patient idiosyncrasy is a common problem in the use of medications, but product variability has been a difficult problem to confirm. Techniques used to produce biologicals may differ in the materials used to make the product, as well as the purification and formulation procedures. Although the preparation procedure must be defined, and limits must be set on the variation between lots, current regulations do not require that products from different manufacturers be compared. However, studies show that differences in immunoglobulin products have led to variation in virus contamination, protein content, structural and functional features, and adverse reactions. Studies have also shown that even when products are manufactured according to a specific procedure, there may be variation between lots causing differences in the incidence of adverse reactions. Immune proteins have become important in the treatment of various immune deficiencies and infections, and better regulations for the preparation of these products are needed to ensure their effectiveness and safety. (Consumer Summary produced by Reliance Medical Information, Inc.)

Standards, Laws, regulations and rules, Biological products industry, Biological products, Immunoglobulins

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Outbreak of invasive mycoses caused by Paecilomyces lilacinus from a contaminated skin lotion

Article Abstract:

Skin lotions may be a possible source for infections from the fungus Paecilomyces (P.) lilacinus that may be life-threatening among patients with compromised immune systems. P. lilacinus infections were identified in 12 of 25 patients admitted over a two-month period to an isolated hospital ward for patients undergoing bone marrow transplants and those with blood cancers. Two patients died. All nine of the bone marrow transplant patients developed P. lilacinus infection resulting in skin lesions. Researchers traced the source of the infection to a skin lotion that was subsequently recalled.

Causes of, Complications and side effects, Contamination, Immunosuppression, Mycoses, Ointments

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Chlorhexidine Compared with Povidone-Iodine as Skin Preparation before Blood Culture

Article Abstract:

Chlorhexidine appears to be a better antiseptic when collecting blood than povidone-iodine. In a study of 403 adults who gave a blood sample, 1.4% of the blood samples became contaminated with bacteria when chlorhexidine was used to sterilize the skin compared to 3.3% when povidone-iodine was used.

Methods, Usage, Blood collection and preservation, Prevention, Chlorhexidine, Microbial contamination

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