Biopharmaceuticals survey

Types of Biopharmaceuticals Survey data on preclinical safety assessment programs were analyzed for 34 biopharmaceuticals cases. The numbers of antibodies, human proteins, and human protein analogues either in the development or marketed as of 2001 in Japan were 13,12, and 6, respectively. The remainder were bioconjugates, DNA-derived vaccines, and human T cell epitopes. Thus antibodies and human proteins are the two major biopharmaceuticals. 

Transgenic plants present enormous potential to become one of the most cost-effective and safe systems for large-scale production of proteins for industrial, pharmaceutical, veterinary, and agricultural uses. Over the past decade, much progress has been made with respect to the development of vaccines, antibodies, and other therapeutic proteins. Biopharmaceuticals in Plants Toward the Next Century of Medicine provides a comprehensive survey of ail major aspects of the development and production of plant-made biopharmaceuticals. 

Trends in U.S. Pharmaceutical Sales and R D 1990-93 PMA Annual Survey Report, Pharmaceutical Manufacturers Association. Washington, DC. 1993. Walsh, G. Biopharmaceuticals Biochemistry and Biotechnology. 2nd Edition, John Wiley Sons. Inc., New York, NY, 2003. 

Animal Species Selection Almost all pharmaceutical companies select animal species for preclinical studies on the basis of the results of the responsiveness of a test animal to the biological activity of a biopharmaceutical and its production of neutralizing antibodies. Such considerations are specifically applicable to biopharmaceuticals but not to new chemical entities (NCEs). This survey finding suggests that most pharmaceutical companies in Japan understand and implement the animal species selection in good accordance with ICH S6. 

Highest Dose Selection It is sometimes difficult to set the highest dose for safety programs of a biopharmaceutical when low or no toxicity is observed in animals. The JPMA questionnaire survey revealed that most pharmaceutical... 

In vitro Studies Table 5.3 shows the in vitro preclinical studies conducted for the 34 biopharmaceuticals. Most were in vitro genotoxicity studies that are not required by the ICH S6 guideline. This is not the case of poor understanding of the ICH S6. In vitro genotoxicity studies are usually conducted at the early stage of development. Almost all the in vitro genotoxicity studies examined by the JPMA survey in 2001 were conducted before the ICH S6 notification. The cross-reactivity studies were used to understand interspecies reactivity to a biopharmaceutical, especially in case of antibodies. 

The safety assessment of biopharmaceuticals in preclinical studies has been improved in Japan with the implementation of the ICH S6. The analysis of data from a questionnaire survey conducted by JPMA suggests that the ICH S6 was well understood and adequately implemented in Japan. The Japanese... 

Separate safety pharmacology studies were completed for many peptides in the survey. Separate safety pharmacology studies are usually performed for NCEs but not biopharmaceuticals. Since rodents are typically used for stand-alone central nervous system and respiratory studies, the usefulness of these studies for NCEs is based on the assumption that rodents are pharmacologically responsive or have some of the same metabolites as would be expected in humans. The lack of concern for metabolism and the significant reduction or absence of pharmacology in rodents with most biopharmaceuticals eliminates the relevance of these studies. In contrast to the larger... 

Survey of Preclinical Toxicology Programs for Approved Biopharmaceuticals... 

This chapter provides a survey of US marketed biopharmaceuticals approved over the past 20 years. It is a simply a profile of the species and types of toxicology studies done for each drug for marketing approval. For a complete list of all preclinical studies for a biopharmaceutical, the reader is directed to the Web sites of the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA). 

This book is not a complete survey of all the physical chemistry underlying pharmacy, but we have selected the most important in pharmaceutics and biopharmaceutics, without dealing with pharmacokinetics or with many aspects of pharmaceutical production, which are covered in specialised textbooks. 

Overall, industry investment in R D is undeniably huge. According to the PhRMA 2006 survey, total biopharmaceutical R D expenditures for 2005, including that by members and non-members, was 51.3 billion, which amounts to about 170 per year for each person in America. Investors, consumers, and other interested parties are bound to keep a sharp eye on bottom-line results and productivity metrics. 

A stability survey was done in 2007 by AAPS Stability Focus Group, benchmarking industry standards and practices of their stability operations within the pharmaceutical and biopharmaceutical industry. It noted that the majority of the industry has used ambient room temperature as the long-term storage condition to conduct stability studies to support clinical trial application. 

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