Biotechnology pharmaceuticals production

Characterization of biotechnology pharmaceutical products, FDA Workshop Proceedings, Washington DC, 1995. 

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. 

Key words biocatalytic membrane, membrane reactor, enzyme- and cell-immobilization, biotechnology, pharmaceutical, products, medical applications, production of bio-ethanol, artificial organs. 

The development of the biotechnology industry presents new and novel molecules derived from nature. The utilization of these molecules as pharmaceutical products presents an analytical challenge of a magnitude greater than ever confronted. The drug candidate and closely-related molecules have... 

These first examples illustrate the importance of a sufficient separation of products and byproducts, whereas membranes are one possibility in pharmaceutical production to obtain this aim. Therefore, they are one key tool to obtaining better quality products and environmentally friendly processes. For a more detailed article about the state of the art of membranes in biotechnology, see Rios et al. [27]. At the same time, it can be seen that stoichiometric cofactor need is no longer a limitation for industrial biotransformations, since they can be overcome with efficient recyclization methods. 

Koneru, P., "To Promote the Progress of Useful Articles An Analysis of the Current Utility Standards of Pharmaceutical Products and Biotechnological Research Tools," IDEA J. L. Technol, 38, 625-671 (1998). 

In light of recent experience with biotechnology-derived products, it is reasonable to expect that pharmacogenomics-based drugs will be expensive relative to traditional modes of treatment (Richmond et al., 1999). If the price of these innovations is viewed out of context from the consumption of other health care goods and services, the response may well be to reduce or deny access to these products. In an era of escalating health care cost, "inputs" to the production of health care, such as pharmaceuticals, physician visits, lab-... 

Articulating the three concepts for harmonization was particularly important. Prospective and retrospective clarify the distinction between work required to avoid conflict when establishing standards for pharmacopeial articles for which standards do not exist, or where few standards exist among the pharmacopeias, from work required to reconcile differences among well-established standards for articles that may have been in the pharmacopeias for considerable time. Prospective harmonization was inaugurated for biotechnology-derived products. Retrospective harmonization focused on pharmaceutical excipients and analytical tests and methods. Forward harmonization expresses a philosophy and environment for harmonization consistent with advances in pharmaceutical analysis. 

For the application of membrane reactors it can be concluded that these are accepted as proven technology for many biotechnological apphcations. The membranes used in this area can operate under relatively mild conditions (low temperature and aqueous systems). However, there is a tremendous potential for membrane reactors in the chemical industry, which often requires apphcation in nonaqueous systems. Long term stability of the membrane materials in these systems will require an ongoing development from the side of materials scientists. As reaction selectivity is of major importance in the production of fine chemicals and pharmaceutical products, it seems plausible to expect that membrane reactors will find their way in the production of chemicals through applications in these areas. 

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Q6B Specifications Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, 1999. 

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 ... 

Biotechnology medicine/ product of pharmaceutical biotechnology Biologic... 

Any pharmaceutical product used for therapeutic or in vivo diagnostic purposes, which is produced in full or in part by biotechnological means... 

Pharmaceutical product Biopharmaceutical Biotechnology medicine Biologic ... 

Currently biotechnology is an integral component of many industries, in addition to pharmaceutical companies. Our treatment of biotechnology and biopharmaceuticals will focus only on the application of biotechnology with respect to biologic entities and biologic processes to develop pharmaceutical products. 

Enhancement in drug delivery and absorption via a specific route of administration often becomes essential in the design of novel pharmaceutical products and new therapies. On the one hand, biotechnological therapeutic molecules usually require enhancers for their successful administration by noninjectable modes alternatively, for the more efficient delivery of conventional drugs, other routes that overcome the disadvantages of traditional administration may also require additional augmentation. 

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