Biotechnology products regulatory considerations

Gerald W. Becker, SSCI, West Lafayette, Indiana, Biotechnology-Derived Drug Product Development Regulatory Considerations in Approval of Follow-On Protein Drug Products... 

For most new biotechnological products, processes and analytical methods have to be newly established. This represents a major and costly part of product development. In newly founded biotechnology firms pertinent technical experience and practical knowledge about the application of regulatory requirements is usually missing and must be developed. Early information and consideration of these aspects may considerably shorten this learning process. 

Petricciani, J.C. (1985). Regulatory considerations for products derived from the new biotechnology. In Large-scale Mammalian Cell Culture. J.Feder and W.R.Tolbert, eds. (New York Academic Press), pp. 79 86. 

Recombinant insulin was the first biotechnology product, which emerged in 1982. Today, biopharmaceutical products have diverged to encompass not only recombinant forms of natural proteins and biologicals derived from natural sources, including recombinant plant-derived pharmaceutical proteins, but also monoclonal antibody (mAb)-based therapeutics. All these products require special consideration from a regulatory point of view. 

Downstream processing involves employment of a purifying system that can isolate the product in as few steps as possible using the simplest purification technology that will achieve the required purity. While purity is a critical consideration for both small-molecule pharmaceuticals and biopharmaceuticals, the nature of biopharmaceutical administration (typically via injection) and the nature of biotechnology processes require that additional considerations be paid to the purity of biopharmaceuticals. The final product must meet regulatory purity and sterility standards and must be below the maximally acceptable cellular or microbial contamination (Ho and Gibaldi, 2003). 

A detailed description of the biochemistry, chemistry and biology of natural colour pigments can be found in the book Natural Food Colorants. The book also covers the role of biotechnology in the production of colorants as well as safety aspects. Another book with the same title, Natural Food Colorants, assembles the manuscripts from a two-day Basic Symposium on Natural Colorants held in Chicago in July 1999. The book covers natural colorant chemistry, preparation, formulation, application and measurement as well as safety, regulatory and health considerations. ... 

New chemical substances are all those not on the Domestic Substances List (DSL), which is a list of substances in commerce in Canada at >100 kg a from 1 January 1984 to 31 December 1986. If a new substance is on the Non-Domestic Substances List (NDSL), the information required for the notification is considerably less than for a standard notification. The NDSL, which is the 1985 US TSCA Inventory (as amended) minus the substances on the DSL, attempts to take account of established substances which did not happen to be sold in Canada during the period for inclusion in the DSL. The first DSL [33] and NDSL [34] were both publish in the Canada Gazette on 26 January 1991, and these inventories will be updated and corrected periodically when necessary. Most polymers are represented on the inventories in terms of the starting materials from which they are manufactured, and products of biotechnology will be included subsequently if necessary when their regulatory controls have been finalised. The DSL and NDSL contain confidential sections, which can be searched by Environment Canada if a bona fide intent to manufacture or import is established by submitting specified data. 

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