Dec 24, 2025 · Biologicals are a class of medicines made from living cells taken from plants, animals or bacteria. These cells are use in creating many types of health care products, …

Jun 12, 2021 · Monoclonal antibodies (mAbs) are immunoglobulins derived from a monoclonal cell line and which have a defined specificity.

Good manufacturing practices (GMP) for biological products were first published by WHO in 1992 (1). This current revision reflects subsequent developments that have taken place in science …

Feb 13, 2025 · Biologic medicines have transformed treatment for numerous chronic and life-threatening conditions such as cancer, auto-immune diseases, and diabetes. These therapies …

Sterility testing Sterility can be defined as the freedom from the presence of viable microorganisms. However, the conditions that guarantee absolute sterility are usually too …

A major industrial application of biotechnology is in the development and preparation of biological medicinal products using genetically engineered bacteria, yeast, fungi, cells or even whole …

Dec 19, 2025 · Biologicals are a diverse group of medicines which include vaccines, growth factors, immune modulators, and monoclonal antibodies, as well as products derived from …

Biotherapeutic products have been successful in treating many life-threatening chronic diseases. However, the cost of innovative biotherapeutics has often been prohibitive, thereby limiting …

Jun 10, 2011 · Biological reference standards are used in qualifying or validating test procedures to ensure uniformity in the designation of potency or activity of biological …

The global research and development of mRNA vaccines have progressed rapidly in the past few years, with a substantial impetus and major accomplishments occurring following the onset of …