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

Author(s): Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc, Associate Professor Chan Lai Wah, BSc (Pharm) (Hon), PhD, Sia Ming Kian, BSc (Pharm) (Hons)

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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Current trends for biosimilars in the Latin American market

Author byline as per print journal: Esteban Ortiz-Prado1,2, MD, MSc, MPH, PhD; Jorge Ponce-Zea3, MSc; Jorge E Vasconez1, MD; Diana Castillo,1, MD; Diana C Checa-Jaramillo1, MD; Nathalia Rodrí­guez-Burneo1, MD; Felipe Andrade2, MD; Damaris P Intriago-Baldeón4, MSc; Claudio Galarza-Maldonado5, MD, PhD Abstract: The number of approved biological medicines in the global pharmaceutical market has increased in […]

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