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Full Description
The globalization of research and development considering collaborative arrangements among companies for producing biotechnology-derived products often raises product comparability issues which are expected to increase in frequency and complexity. This volume reviews current scientific developments and regulatory issues relating to establishing comparability of biological products when manufactured within a single company or jointly among two or more companies (e.g. manufacturing changes, site changes). Recommendations for a framework constituting a harmonized document on comparability are also provided. A cadre of international regulatory and industry experts concluded and recommended that a) the unprecedented record of product safety enjoyed by the biotech industry is founded on the vigilance dedicated to process controls and product quality throughout the drug development continuum; b) intra-manufacturer process changes are in line with modern global practices, scientific and economic considerations; c) the innovators' proprietary development history, production experience, training, validated assays and standards constitute a solid basis for performing legitimate and scientifically rigorous comparisons of products when introducing manufacturing changes. Importantly, depending on the nature of the product, at times, comparisons may dictate expanded investigations in clinical trials; d) comparability, while robust in concept and application within one manufacturer's product, is not a surrogate for establishing inter-manufacturer therapeutic equivalence which is the foundation for 'generic' products; e) an international harmonized approach guidance document is timely. Summarizing current thinking and practical experience, these proceedings should be read by academic, industry, and regulatory scientists who work with biological products prepared for use as vaccines, plasma derivatives, or therapeutic products.
Contents
The product development continuum - the evolution and application of the concept of comparability, R.L. Garnick; a global view of comparability concepts, J. Petricciani; immunogenicity - concepts/issues/concerns, K.E. Stein. Regulatory and industry panel - perspectives on comparability - a global view: perspective on assessing comparability of biotechnology products - a view from Japan, T. Hayakawa; a Canadian perspective on assessing comparability of biotechnology products, A. Ridgeway; European Industry Position (EFPIA), B. Hughes. Strategies for demonstrating comparability: regulatory philosophy for comparability protocols. Immunogenicity: challenges with current technology for the detection, measurement and characterization of antibodies against biological therapeutics, A.R. Mire-Sluis; use of biosensors to monitor the immune response, S.J. Swanson, D. Mytych, J. Ferbas; experience measuring antibodies to prediction of immungenicity, E. Koren. Clinical immunogenicity - occurrence and impacts - industry experience: Enbrel (etanercept), C.A. Foerder, M.C. Rogge; immune response to recombinant B domain deleted factor VIII (ReFacto), B. Rup; the use of an animal immunogenicity model in the development of protropin somatrem (methionyl human growth hormone), A.J.S. Jones. Chemistry/manufacturing/controls (CMC): viral safety and clearance evaluation - implications for process change and comparability, M. Dinowitz; detection and consequences of recombinant protein isoforms - implications for biological potency, M.M. Federici, et al. closing remarks: the pharmacopoeial perspective in accelerating the development and availability of biologicals and biotechnological-derived products.
