Biopharmaceuticals guidelines

Rathore, A. and Sofer, G. (eds). 2005. Process Validation in Manufacturing of Biopharmaceuticals Guidelines, Current Practices, and Industrial Case Studies. Taylor and Francis. 

Nims, R., Presene, E., Sofer, G., Phillips, C., and Chang, A. (2005), Adventitious agents Concerns and testing for biopharmaceuticals, in Rathore, A. S., and Sofer, G., Eds., Process Validation in Manufacturing of Biopharmaceuticals Guidelines, Current Practices, and Industrial Case Studies, Taylor and Francis, Boca Raton, FL. 

Validation activity is the crucial end-stage in the process development of a biopharmaceutical chromatographic purification and one which young companies often underestimate. Regarding process validation, the FDA issued a guideline in 1986 which states ... 

In addition, tests for mutagenicity and carcinogenicity are not likely required for most biopharma-ceutical substances. The regulatory guidelines and industrial practices relating to biopharmaceuti-cal preclinical trials thus remain in an evolutionary mode, and each product is taken on a case-by-case basis. An overview of the main preclinical tests undertaken for a sample biopharmaceutical... 

According to current PDA guidelines, an acceptable pharmaceutical product should exhibit less than 10% deterioration after 2 years.5 Protein biopharmaceuticals usually have to be stored under refrigerated conditions or freeze dried to achieve an acceptable shelf life. EL IS As for aggregates and product variants as discussed previously would be applicable for determining shelf life. 

The publication of the U.S. FDA Guidelines allowing the waiver of bioequivalence study for compounds classified as Class I based on the Biopharmaceutics Classification System... 

The successful application of CE technology has resulted in dramatic growth of CE as an essential tool for protein characterization, R D, and QC of therapeutic biomolecules. CE methods have clearly been shown to be superior over traditional slab-gel methods. Many biopharmaceutical companies have adopted CE techniques in QC environments for determination of product purity, identity and consistency needed for the release of protein products. The success of validation per ICH guidelines has moved CE technology to a position of greater prominence and ensures the quality release of therapeutic proteins and antibodies. 

Guideline on PDA (Parenterals Drug Association Inc.) of Validation of Pharmaceutical and Biopharmaceuticals, February 1993. 

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