Source: Nature biotechnology [Nat Biotechnol] 2016 Apr; Vol. 34 (4), pp. 393-400.Publisher: Nature America Publishing Country of Publication: United States NLM ID: 9604648 Publication Model: Print Cited Medium: Internet ISSN:

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Academic Journal

Biopharmaceutical benchmarks--2003.

Authors : Walsh G; Industrial Biochemistry Programme, University of Limerick, Limerick, Ireland.

Subjects: Biopharmaceutics/Biopharmaceutics/Biopharmaceutics/*economics ; Biopharmaceutics/Biopharmaceutics/Biopharmaceutics/*statistics & numerical data ; Drug Approval/Drug Approval/Drug Approval/*economics

Source: Nature biotechnology [Nat Biotechnol] 2003 Aug; Vol. 21 (8), pp. 865-70.Publisher: Nature America Publishing Country of Publication: United States NLM ID: 9604648 Publication Model: Print Cited Medium: Print ISSN:

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Editorial & Opinion

Why an abbreviated FDA pathway for biosimilars is overhyped.

Authors : Miller HI

Subjects: Biopharmaceutics/Biopharmaceutics/Biopharmaceutics/*legislation & jurisprudence ; Drugs, Generic/Drugs, Generic/Drugs, Generic/*standards ; United States Food and Drug Administration/United States Food and Drug Administration/United States Food and Drug Administration/*organization & administration

Source: Nature biotechnology [Nat Biotechnol] 2011 Sep 08; Vol. 29 (9), pp. 794-5. Date of Electronic Publication: 2011 Sep 08.Publisher: Nature America Publishing Country of Publication: United States NLM ID: 9604648 Publication Model: Electronic Cited Medium: Internet ISSN:

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Academic Journal

Biopharmaceutical benchmarks 2010.

Authors : Walsh G; Industrial Biochemistry Program, Department of Chemical and Environmental Sciences, Materials and Surface Science Institute, University of Limerick, Limerick City, Ireland.

Subjects: Benchmarking/Benchmarking/Benchmarking/*standards ; Biopharmaceutics/Biopharmaceutics/Biopharmaceutics/*standards; Antibodies, Bispecific/Antibodies, Bispecific/Antibodies, Bispecific/economics

Source: Nature biotechnology [Nat Biotechnol] 2010 Sep; Vol. 28 (9), pp. 917-24.Publisher: Nature America Publishing Country of Publication: United States NLM ID: 9604648 Publication Model: Print Cited Medium: Internet ISSN:

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Academic Journal

Quality by design for biopharmaceuticals.

Authors : Rathore AS; Process Development, M/S 30-2-A, One Amgen Center Drive, Thousand Oaks, California 91320, USA. ; Winkle H

Subjects: Biopharmaceutics*; Biological Products/Biological Products/Biological Products/*pharmacology; Biological Products/Biological Products/Biological Products/chemical synthesis

Source: Nature biotechnology [Nat Biotechnol] 2009 Jan; Vol. 27 (1), pp. 26-34.Publisher: Nature America Publishing Country of Publication: United States NLM ID: 9604648 Publication Model: Print Cited Medium: Internet ISSN:

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Academic Journal

Building biomanufacturing capacity--the chapter and verse.

Authors : Kamarck ME; Wyeth Biotech, 500 Arcola Road, Collegeville, Pennsylvania 19426, USA.

Subjects: Biopharmaceutics*; Biotechnology/Biotechnology/Biotechnology/*instrumentation ; Biotechnology/Biotechnology/Biotechnology/*methods

Source: Nature biotechnology [Nat Biotechnol] 2006 May; Vol. 24 (5), pp. 503-5.Publisher: Nature America Publishing Country of Publication: United States NLM ID: 9604648 Publication Model: Print Cited Medium: Print ISSN:

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Academic Journal

Flexibility--the guiding principle for antibody manufacturing.

Authors : Carson KL; The Williamsburg BioProcessing Foundation, Foundation PO Box 1229, 1206 Laskin Road, Suite 201, Virginia Beach, Virginia 23451, USA.

Subjects: Antibodies, Monoclonal/Antibodies, Monoclonal/Antibodies, Monoclonal/*chemistry ; Biopharmaceutics/Biopharmaceutics/Biopharmaceutics/*methods; Animals

Source: Nature biotechnology [Nat Biotechnol] 2005 Sep; Vol. 23 (9), pp. 1054-8.Publisher: Nature America Publishing Country of Publication: United States NLM ID: 9604648 Publication Model: Print Cited Medium: Print ISSN:

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Editorial & Opinion

The quintessence of immunogenicity reporting for biotherapeutics.

Authors : Shankar G; Janssen Research &Development, LLC (Johnson &Johnson), Spring House, Pennsylvania, USA.; Arkin S

Subjects: Disclosure*; Biological Products/Biological Products/Biological Products/*adverse effects ; Biological Products/Biological Products/Biological Products/*immunology

Source: Nature biotechnology [Nat Biotechnol] 2015 Apr; Vol. 33 (4), pp. 334-6.Publisher: Nature America Publishing Country of Publication: United States NLM ID: 9604648 Publication Model: Print Cited Medium: Internet ISSN:

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Editorial & Opinion

The nature of Asian biopharmaceutical innovation.

Authors : Friedman Y; DrugPatentWatch.com and Thinkbiotech, Washington, DC, USA.

Subjects: Drug Design* ; Organizational Innovation*; Biopharmaceutics/Biopharmaceutics/Biopharmaceutics/*statistics & numerical data

Source: Nature biotechnology [Nat Biotechnol] 2014 Jun; Vol. 32 (6), pp. 523-4.Publisher: Nature America Publishing Country of Publication: United States NLM ID: 9604648 Publication Model: Print Cited Medium: Internet ISSN:

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