Biotechnological production Subject

Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process Specifications... 

Biotechnology products require different kinds of equipment for both small- and large-scale operations and this subject will be covered in detail in later chapters. 

ICH Q5E. Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, 18 November 2004. 

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. ... 

The product family summarized as biopharmaceuticals comprises a heterogeneous group of drag products which, in contrast to non-biopharmaceuticals, do not originate from conventional chemical synthesis, but either from intact biosystems or from any biotechnological production process. (For a comprehensive overview of this subject, see the Introduction.)... 

For further reviews comprehensively illustrating issues of biotechnological production processes, the reader is referred to further review articles [1-8]. To look up basic subjects of molecular and cellular biology, the reader is referred to textbooks [9,10]. 

Farnley and colleagues [96] have recently reviewed the complexity of intellectual property around biotechnology and biotechnology products. The authors note that the IP issues for small molecules and macromolecules, with a few exceptions, may be more similar than commonly assumed. The most important difference relevant to this overview is that each step in the discovery process may potentially be subject to different intellectual property considerations, which the authors note as unusual. The major differences between small-molecule and macromolecule patenting are shown in Table 1.3-11. 

Food and Drug Administration. (2005) International conference on harmonisation Guidance on Q5E comparability of biotechnological/biological products subject to changes in their manufacturing process. Notice. Fed Regist, 70 (125), 37861-37862. 

The only well-documented outbreak of asthmatic symptoms caused by exposure to the biotechnological product was the widespread problem of asthma caused by exposure to Bacillus subtilis proteases in the washing powder industry. During the later 1960s and early 1970s these outbreaks were reported by occupational hygienists, company medical officers and respiratory disease specialists. They were the subject of many papers. 

The first of these can be used when a product is to be marketed in a single country. It can be used for any type of application except for certain types of biotechnology-based items. Having been approved in one country, in most cases an application to a second country will trigger the Mutual Recognition procedure in other concerned countries. There are certain exceptions to this, e.g., where a product has different summaries of product characteristics (SmPCs) in different countries, and these have not been subjected to a harmonization procedure. Line extensions to such products could also remain subject to national procedures. 

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