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PAT Applied in Biopharmaceutical Process Development And Manufacturing
As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH). Given the rapid growth in the biopharmaceutical area and the comp
Bioproducts and Bioprocesses 2
Introduction During the week of January 6-10, 1991, the Third U.S.-Japan Conference on Biotechnology was held at the Asian-Pacific Conference Center at the Univer sity of Hawaii in Honolulu. This book is a compilation of the papers and posters presented at the Conference. The Conference was sponsored, in part, by the U.S. pharmaceutical companies including National Science Foundation and Ortho Pharmaceutical, Merck, Genentech, Smith Kline Beecham and ABEe. Its purpose was to promote information exchange between Japanese and U.S. researchers, primarily academics, in biotechnology and to seek ways to carry out collaborative research in biotechnology. The honorary chairmen of the Conference were Professor H. Okada and me. The formal program was organized by Professors 1. Bailey and T. Yoshida. Twelve invited formal presentations were given from each side. In addition, both sides were invited to bring along five observers to the Conference who were encouraged to prepare poster presentations on their research. Paper abstracts plus bibliographies were exchanged prior to the Conference in order to promote maximum technical interaction between the participants.
Protein Purification Process Engineering
Offers coverage of the development of protein purification processes for large-scale commercial operations, and addresses process development, scale-up, applications and mathematical descriptions. Technologies currently used at the commercial scale are covered in depth.
Gene Expression in Recombinant Microorganisms
Describing the scientific and commercial applications of microbial recombinant DNA technology, this outstanding, single-source reference offers state-of-the-art reviews of gene expression in the most important classes of recombinant microorganisms-providing numerous examples of the expression of homologous genes or heterologous gene products. Presents a unique collection of safety and regulatory considerations from around the world and addresses specific measures to be taken for large-scale industrial operations!
Process Scale Bioseparations for the Biopharmaceutical Industry
The biopharmaceutical industry has become an increasingly important player in the global economy, and the success of these products depends on the development and implementation of cost-effective, robust and scaleable production processes. Bioseparations-also called downstream processing- can be a key source of competitive advantageto biopharmaceut
Biotransformations and Bioprocesses
From the laboratory to full-scale commercial production, this reference provides a clear and in-depth analysis of bioreactor design and operation and encompasses critical aspects of the biocatalytic manufacturing process. It clarifies principles in reaction and biochemical engineering, synthetic and biotransformation chemistry, and biocell and enzy
Thermophiles
We might think of them as living on the very edge of existence. Referred to as extremophiles, these microorganisms exhibit the most radical capacity for adaptation in those harsh environments that are just barely conducive to the existence of cellular life. Unlocking the mechanisms and understanding the evolutionary development that allows these si
