Regulatory considerations in biosimilars: Asia pacific regions

Rathore, Anurag S.; Bhargava, Ankita

doi:10.1080/10826068.2020.1815061

Cited by 11 publications

(7 citation statements)

References 7 publications

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“…Following the patent cliff of certain innovator products and the growing support from the major regulatory agencies, there has been a steady increase in the number of biosimilar approvals. At present, region and country-specific biosimilar regulatory pathways and guidance are at different stages of development and implementation ( Rathore and Bhargava, 2020 ; 2021a ; 2021b ; 2021c ). There is a growing interest in increasing global harmonization of the regulatory guidelines for biosimilar development including selection of the reference product, nomenclature, and the design of analytical, non-clinical, or clinical biosimilarity studies.…”

Section: Global Landscape On Biosimilar Approvalsmentioning

confidence: 99%

Analytical Similarity Assessment of Biosimilars: Global Regulatory Landscape, Recent Studies and Major Advancements in Orthogonal Platforms

Nupur

Joshi

Gulliarme

et al. 2022

Front. Bioeng. Biotechnol.

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Biopharmaceuticals are one of the fastest-growing sectors in the biotechnology industry. Within the umbrella of biopharmaceuticals, the biosimilar segment is expanding with currently over 200 approved biosimilars, globally. The key step towards achieving a successful biosimilar approval is to establish analytical and clinical biosimilarity with the innovator. The objective of an analytical biosimilarity study is to demonstrate a highly similar profile with respect to variations in critical quality attributes (CQAs) of the biosimilar product, and these variations must lie within the range set by the innovator. This comprises a detailed comparative structural and functional characterization using appropriate, validated analytical methods to fingerprint the molecule and helps reduce the economic burden towards regulatory requirement of extensive preclinical/clinical similarity data, thus making biotechnological drugs more affordable. In the last decade, biosimilar manufacturing and associated regulations have become more established, leading to numerous approvals. Biosimilarity assessment exercises conducted towards approval are also published more frequently in the public domain. Consequently, some technical advancements in analytical sciences have also percolated to applications in analytical biosimilarity assessment. Keeping this in mind, this review aims at providing a holistic view of progresses in biosimilar analysis and approval. In this review, we have summarized the major developments in the global regulatory landscape with respect to biosimilar approvals and also catalogued biosimilarity assessment studies for recombinant DNA products available in the public domain. We have also covered recent advancements in analytical methods, orthogonal techniques, and platforms for biosimilar characterization, since 2015. The review specifically aims to serve as a comprehensive catalog for published biosimilarity assessment studies with details on analytical platform used and critical quality attributes (CQAs) covered for multiple biotherapeutic products. Through this compilation, the emergent evolution of techniques with respect to each CQA has also been charted and discussed. Lastly, the information resource of published biosimilarity assessment studies, created during literature search is anticipated to serve as a helpful reference for biopharmaceutical scientists and biosimilar developers.

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Section: Global Landscape On Biosimilar Approvalsmentioning

confidence: 99%

Analytical Similarity Assessment of Biosimilars: Global Regulatory Landscape, Recent Studies and Major Advancements in Orthogonal Platforms

Nupur

Joshi

Gulliarme

et al. 2022

Front. Bioeng. Biotechnol.

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“…Additionally, different silica sizes and shapes are contributed to the incomplete core reaction as a result of varying age and temperature 46 , 47 . Apart from that, nano-sizing of silica nanoparticles was obtained after undergoes with centrifugation processes and nano-filtration procedures 48 . Next, the comprehensive morphology analysis was continued to examine the graphene.…”

Section: Resultsmentioning

confidence: 99%

Silica and graphene mediate arsenic detection in mature rice grain by a newly patterned current–volt aptasensor

Uda

Gopinath

Hashim

et al. 2021

Sci Rep

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Arsenic is a major global threat to the ecosystem. Here we describe a highly accurate sensing platform using silica nanoparticles/graphene at the surface of aluminum interdigitated electrodes (Al IDE), able to detect trace amounts of arsenic(III) in rice grain samples. The morphology and electrical properties of fabricated Al IDEs were characterized and standardized using AFM, and SEM with EDX analyses. Micrometer scale Al IDEs were fabricated with silicon, aluminum, and oxygen as primary elements. Validation of the bare Al IDE with electrolyte fouling was performed at different pH levels. The sensing surface was stable with no electrolyte fouling at pH 7. Each chemical modification step was monitored with current–volt measurement. The surface chemical bonds were characterized by fourier transform infrared spectroscopy (FTIR) and revealed different peaks when interacting with arsenic (1600–1000 cm−1). Both silica nanoparticles and graphene presented a sensitive limit of detection as measured by slope calibration curves at 0.0000001 pg/ml, respectively. Further, linear regression was established using ΔI (A) = 3.86 E−09 log (Arsenic concentration) [g/ml] + 8.67 E−08 [A] for silica nanoparticles, whereas for graphene Y = 3.73 E−09 (Arsenic concentration) [g/ml] + 8.52 E−08 on the linear range of 0.0000001 pg/ml to 0.01 pg/ml. The R2 for silica (0.96) and that of graphene (0.94) was close to the maximum (1). Modification with silica nanoparticles was highly stable. The potential use of silica nanoparticles in the detection of arsenic in rice grain extract can be attributed to their size and stability.

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“…As global demand increases and more biosimilars enter the biopharmaceutical market, the main challenge to the industry is to develop high-efficiency and cost-effective production processes. [1,2] Many industries, for example, petrochemical, steel, and food have accomplished the transition from batch to continuous production to improve productivity and lower the cost. However, the continuous process has not been widely implemented in the biopharmaceutical industry.…”

Section: Introductionmentioning

confidence: 99%

“…First, bind-elute chromatography, which is commonly used in downstream purification, is not continuous. Second, process automation, which is an essential tool for process continuity, can be difficult to build up for the following reasons: (1) the equipment utilized in downstream process are from different vendors, making system integration difficult; (2) the available process analytical technology (PAT) tool in downstream is very limited. In the past 10 years, the above hurdles have been cleared gradually.…”

Section: Introductionmentioning

confidence: 99%

Converting a mAb downstream process from batch to continuous using process modeling and process analytical technology

Chen

Shi

et al. 2022

Biotechnology Journal

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The biopharmaceutical market is driving the revolution from traditional batch processes to continuous manufacturing for higher productivity and lower costs. In this work, a batch mAb downstream process has been converted into an integrated continuous process with the combination of multiple techniques. For process intensification, two batch mode unit operations (protein A capture chromatography, ultrafiltration/diafiltration) were converted into continuous ones; for continuity, surge tanks were used between adjacent steps, and level signals were used to trigger process start or stop, forming a holistic continuous process. For process automation, manual operations (e.g., pH and conductivity adjustment) were changed into automatic operation and load mass was controlled with process analytical technology (PAT). A model-based simulation was applied to estimate the loading conditions for the continuous capture process, resulting in 21% resin capacity utilization and 28% productivity improvement as compared to the batch process. Automatic load mass control of cation exchange chromatography (CEX) was achieved through a customized in-line protein quantity monitoring system, with a difference of less than 1.3% as compared to off-line analysis. Total process time was shortened from 4 days (batch process) to less than 24 hours using the continuous downstream process with the overall productivity of 23.8 g mAb per day for the bench-scale system. Comparable yield and quality data were obtained in three test runs, indicating a successful conversion from a batch process to a continuous process. The insight of this work could be a reference to other similar situations.

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Regulatory considerations in biosimilars: Asia pacific regions

Cited by 11 publications

References 7 publications

Analytical Similarity Assessment of Biosimilars: Global Regulatory Landscape, Recent Studies and Major Advancements in Orthogonal Platforms

Analytical Similarity Assessment of Biosimilars: Global Regulatory Landscape, Recent Studies and Major Advancements in Orthogonal Platforms

Silica and graphene mediate arsenic detection in mature rice grain by a newly patterned current–volt aptasensor

Converting a mAb downstream process from batch to continuous using process modeling and process analytical technology

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