Nov 3, 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, including vaccines. This …

Nov 19, 2004 · Home / Teams / Technical standards and specifications / Norms and standards for Biological Products / Guidelines for Biologicals

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 animals …

May 19, 2025 · This year’s International Day for Biological Diversity, on Thursday, 22 May 2025, highlights the inherent connections between people and the natural world through the theme, …

Sep 6, 2018 · Biological and toxin weapons are either microorganisms like virus, bacteria or fungi, or toxic substances produced by living organisms that are produced and released deliberately to cause …

The WHO sterility testing guidelines are applicable across a wide range of biological medicinal products including vaccines, blood products, biotechnology products, and cell and tissue products.

The catalogue of international reference standards for biological products is updated following the Expert Committee on Biological Standardization meetings. See below for the catalogue, listed in …

Apr 15, 2025 · This guideline is intended to provide recommendations for the validation of bioanalytical methods for chemical and biological drug quantification in biological matrices and their application in …

Dec 21, 2020 · This fourth edition of the manual builds on the risk assessment framework introduced in the third edition. A thorough, evidence-based and transparent assessment of the risks allows safety …

Biological starting materials: starting materials derived from a biological source that mark the beginning of the manufacturing process of a drug, as described in a marketing authorization or licence …