Biotechnology products definition

The bulk production of sterile drug products such as antibiotics, corticosteroids, insulin, and certain biotechnology products requires that a number of processes be carried out under aseptic conditions. These processes can be evaluated in a manner adapted from those employed for aseptic filling processes. A joint PDA/PhRMA task force has developed the definitive guidance document on this subject. ... 

There are no detailed recommendations for analytical procedures in the field of biotechnological production of drugs, in contrast to the recommendations made by the FDA for bioanalytical methods [16], The absence of detailed guidelines for analytical method validation in this field is surprising. It is important to validate the quantification of both substrate and product during the process, at definite time intervals, to ensure proper calculation of the kinetics of the process i.e., the coefficients of substrate conversion, and production rates must be adequately calculated. The aim of the study in pa-... 

Zoon K, Garnick R (1998). Definition of a well-characterized biotechnology product. In F Brown, A Lubiniecki, G Murano (eds.). Characterization of Biotechnology Pharmaceutical Products, Vol. 96, Dev. Biol. Stand. Karger, Basel Switzerland, pp. 191-197. 

Definition. Biotechnology products are those that are prepared using biological, rather than chemical synthetic, processes. Biological processes may be manipulated in vivo, ex vivo or in vitro. 

While it might be assumed that biologic refers to any pharmaceutical product produced by biotechnological endeavour, its definition is more limited. In pharmaceutical circles, biologic ... 

As used herein, biotechnology medicines or products of pharmaceutical biotechnology are afforded a much broader definition. Unlike the term biopharmaceutical , the term... 

The definition of a process based on biotechnology is sufficiently broad to capture a wide arrange of medicinal products, such as recombinant proteins and gene-based therapeutics, and prophylactics, such as gene transfer medicinal products and DNA vaccines. Medicinal products manufactured by biotechnological processes as defined in the Annex to Regulation (EC) 726/2004 must be authorized centrally pursuant to article 3 of the Regulation. 

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