Biopharmaceuticals future developments

In 1996, about 10 years after the introduction of the first recombinant DNA product for human use, the FDA modified and streamlined the approval process for biotechnology products considered to be well characterized. These modifications, in essence, established the direction of how biologic macromolecules are researched and developed today in biotechnology-based and traditional pharmaceutical companies [2]. Well-characterized biotechnology products include (1) synthetic peptides consisting of fewer than 20 amino acids, (2) monoclonal antibodies and derivatives, and (3) recombinant DNA-derived products. Anticipating future developments, the FDA is also prepared to consider DNA plasmid products as well-characterized when the first medicinal in this class is submitted for approval. CBER now approves well-characterized biopharmaceuticals under the BLA process [3]. 

Future developments in the biopharmaceutical industry are likely to impact the scope and execution of process validation activities. The nature of process validation is continuously changing to meet the requirements of biopharmaceutical development and manufacturing. The understanding and implementation of new strategies based on future developments is key to maintaining an effective process validation methodology. 

Lennernas H and Abrahamsson B (2005) The Use of Biopharmaceutic Classification of Drugs in Drug Discovery and Development Current Status and Future Extension. J Pharm Pharmacol 57 pp 273-285. 

Lennernas H, Abrahamsson B (2005) The use of biopharmaceutic classification of drugs in drug discovery and development Current status and future extension. J Pharm Pharmacol 57 273-285. 

This chapter illustrated the broad spectrum of uses for plant-derived vaccines and therapeutic proteins. Many of the biopharmaceuticals listed in this chapter were developed in transgenic tobacco or potato plants. While tobacco is not ideal for the expression of vaccine proteins nor is raw potato ideal for oral consumption, they are both relatively easy to work with and have been well characterized, making them useful for proof-of-concept studies. The use of plants for production systems and delivery vehicles holds great promise for future biopharmaceutical development. Proteins can be produced in plants while remaining biologically functional they can be scaled up for large production and purified inexpensively and with relative ease. The following chapters describe the many attributes of plant-made biopharmaceuticals in more detail. 

M. M. Struck, Biopharmaceutical R D success rates and development times. A new analysis provides benchmarks for the future, Bio/Techndogy 1994, 12, 674-677. 

The purpose of this overview chapter is to provide perspectives in the current status and future prospects of controlled release drug delivery. This is accomplished by examining various delivery systems from a mechanistic point of view, exploring applications of these systems, and discussing relevant biopharmaceutical parameters. A major section of this book is devoted to fundamental issues and applications of transdermal and transmucosal delivery systems (Chapter 6,8,17-23). Other developing systems of future potential... 

In February of 20051 received an invitation from Jonathan Rose, then assistant editor for sponsoring and acquisitions with Wiley s Scientific, Technical and Medical Division, to develop a book on the preclinical assessment for biopharmaceuticals. Since that time Jonathan Rose has been promoted to Editor of Wiley-Blackwell, and I have become a bit wiser in accepting such invitations in the future. 

Years ago powders were used as dosage forms more frequently before the advent of more modern forms. However, biopharmaceutical problems arose with these new drug dosage forms, and companies have returned to powders and developed these further. Industrial sachet manufacturing considerably reduces handling and improves storage. Pressurized systems allow easy dispensation of disinfectants, which increases patients compliance. It can be expected that powders will continue to be used in the future. 

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