Articles

Editor's Letter

Published on 26 April 2022

First 2022 GaBI Journal issue highlights

The first GaBI Journal issue of 2022 comes at a time of both hope and despair. While the COVID-19 pandemic continues to cause significant global morbidity and mortality; especially in...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2022.1101.001

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Published on 26 April 2022

2022/1 GaBI Journal Table of Contents

Contents Editor’s Letter First 2022 GaBI Journal issue highlights Letter to Editor No need for systematic switch studies to demonstrate interchangeability of biosimilars Review Article Biotherapeutic products in the European...

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Sponsored Article

Published on 25 April 2022

Structural characterization methods for biosimilars: fit-for-purpose, qualified or validated

Abstract: Detailed and accurate structural characterization of biopharmaceuticals is of paramount importance for product definition, assessment of impurities and achieving in-depth understanding of manufacturing processes. But how can we have...

Author(s): Richard L Easton, BSC (Hons), DIC, PhD

analytical development, mass spectrometry, process related impurities, structural characterization

DOI: 10.5639/gabij.2022.1101.007

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Review Article

Published on 07 April 2022

Long-acting insulin analogues. Drug selection by means of the System of Objectified Judgement Analysis (SOJA)

Author byline as per print journal: Robert Janknegt, PharmD, PhD; Marloes Dankers, MSc Study objectives: The increasing number of long-acting insulin analogues makes it difficult for general practitioners to have...

degludec, detemir, diabetes mellitus, glargine, long-acting insulin analogues, NPH insulin

DOI: 10.5639/gabij.2022.1101.005

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Sponsored Article

Published on 04 April 2022

Biosimilar monoclonal antibodies development simplified

Author(s): Jennifer Campbell

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Review Article

Published on 30 March 2022

Manufacture and regulation of cell, tissue and gene therapy products: global perspectives, challenges and next steps

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc; Christine Koh, BSc (Pharm) (Hon); Associate Professor Chan Lai Wah, BSc (Pharm) (Hon), PhD Abstract: Cell,...

cell, good manufacturing practice, quality control, regulatory framework, tissue and gene therapy products

DOI: 10.5639/gabij.2022.1102.012

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Review Article

Published on 28 February 2022

Challenges in the manufacture, storage, distribution and regulation of traditional and novel vaccines

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock1, BSc (Pharm), MSc; Adelia Pheh1, BSc (Pharm) (Hon); Vimal Sachdeva2, MSc; Associate Professor Chan Lai Wah1, BSc (Pharm)...

challenges, COVID-19 vaccines, harmonization, manufacturing, regulation, traditional vaccines

DOI: 10.5639/gabij.2022.1101.004

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Review Article

Published on 28 January 2022

Biotherapeutic products in the European Pharmacopoeia: have all challenges been tackled?

Author byline as per print journal: Mihaela Buda, PhD; Olga Kolaj-Robin, PhD; Emmanuelle Charton, PhD Abstract: The approach to the elaboration of European Pharmacopoeia (Ph. Eur.) monographs in the field of...

biosimilars, biotherapeutics, monographs, pharmacopoeia, public standards

DOI: 10.5639/gabij.2022.1101.003

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Opinion

Published on 17 December 2021

Biosimilarity is not a transitive property: implication for interchangeability, naming and pharmacovigilance

Abstract: Current regulations do not require a given biosimilar to remain similar to its reference biological over time. However, two products that were initially deemed biosimilar or interchangeable could each...

Author(s): Pablo Matar, PhD

divergence, drift, evolution, interchangeability, pharmacovigilance, variability

DOI: 10.5639/gabij.2022.1101.006

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Letters to the Editor

Published on 17 December 2021

No need for systematic switch studies to demonstrate interchangeability of biosimilars

Abstract: Systematic clinical switch studies to demonstrate interchangeability of biosimilars are required in some jurisdictions while theoretical considerations and current clinical data question the feasibility and relevance of such studies....

Author(s): Adjunct Professor Pekka Kurki, MD, PhD

biosimilars, immunogenicity, interchangeability, switch studies

DOI: 10.5639/gabij.2022.1101.002

6.679 views

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