Search results for ASEAN

Quality standards for biopharmaceuticals: the importance of good manufacturing practice

Abstract: Regulatory standards for recombinant DNA (rDNA)-derived medicinal products put in place over 40 years ago provided a framework for moving forward with novel biotechnologies and biosimilars leading to their success as highly eff ective medicines. As biologicals and biosimilars are increasingly developed, licensed and used worldwide less experienced manufacturers and regulatory agencies need support […]

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Global challenges in the manufacture, regulation and international harmonization of GMP and quality standards for biopharmaceuticals

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc; Associate Professor Sia Ming Kian, BSc (Pharm) (Hons); Chan Lai Wah, BSc (Pharm) (Hons), PhD Abstract: Biopharmaceuticals belong to a class of medicinal products whose active pharmaceutical ingredient (API) is manufactured using living systems such as microbial and mammalian cells. […]

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First ASEAN educational workshop on regulation and approval of biosimilars/similar biotherapeutic products 2017 – Report

Author byline as per print journal: Robin Thorpe, PhD, FRCPath; Elwyn Griffiths, PhD, DSc; Niklas Ekman, PhD Abstract: Biosimilar medicines are being increasingly developed and used worldwide. Many regulatory agencies across the globe are assessing how policy and regulation can be adapted and developed to ensure that biosimilars can enter markets successfully, without affecting the safety […]

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1st ASEAN overview workshop on GMP for biologicals/biosimilars 2018 – Report

Introduction: The Association of Southeast Asian Nations (ASEAN) Overview Workshop on GMP for Biologicals and Biosimilars was co-organized with the Generics and Biosimilars Initiative (GaBI). This meeting was intended to improve the understanding of the good manufacture practice (GMP) inspection framework for biological (and biosimilar) drugs among ASEAN countries. Methods: The workshop was held on […]

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