2018
DOI: 10.1080/14712598.2018.1421169
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Maintaining consistent quality and clinical performance of biopharmaceuticals

Abstract: Biopharmaceuticals are large protein based drugs which are heterogeneous by nature due to post translational modifications resulting from cellular production, processing and storage. Changes in the abundance of different variants over time are inherent to biopharmaceuticals due to their sensitivity to subtle process differences and the necessity for regular manufacturing changes. Product variability must thus be carefully controlled to ensure that it does not result in changes in safety or efficacy. Areas cove… Show more

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Cited by 48 publications
(47 citation statements)
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“…Therefore, in comparison to other isolation methods TFF is more suitable for clinical use, despite not being able to separate different types of biological nanoparticles, resulting in a heterogeneous product. In fact, from a regulatory perspective, the batch‐to‐batch consistency of the product is more important than the heterogeneity 29…”
Section: Resultsmentioning
confidence: 99%
“…Therefore, in comparison to other isolation methods TFF is more suitable for clinical use, despite not being able to separate different types of biological nanoparticles, resulting in a heterogeneous product. In fact, from a regulatory perspective, the batch‐to‐batch consistency of the product is more important than the heterogeneity 29…”
Section: Resultsmentioning
confidence: 99%
“…Differences in quality attributes have been observed for marketed products [2,[6][7][8][9][10]. In limited cases, changes in quality attributes have led to clinically relevant differences between different batches of the same product [11][12]. Recently this was shown for originator version of the monoclonal antibody trastuzumab (Herceptin ® ), where a drift in the proportion of non-fucosylated glycans was associated with a reduced event-free survival (EFS) rate in patients receiving trastuzumab in the neo-adjuvant setting [12].…”
Section: Introductionmentioning
confidence: 99%
“…Specifications define the standards for ensuring consistent quality of a (biological) product throughout its lifecycle. They are agreed upon with regulatory authorities and include a large number of in-process controls and tests, as well as release criteria, so that no significant drifting of CQAs occurs over time, for example, following changes to its manufacturing process [11,[14][15][16]. By definition, a CQA is a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality.…”
Section: Introductionmentioning
confidence: 99%
“…After patient expiry, new biosimilar medicines come to the market with price discount. Biosimilars with EMA/ FDA approval have similar safety and efficacy profile as the original biological medicines in case of new patients [20][21][22]. In an internal price referencing system, such price discount may also incentivize the manufacturer of the off-patent originator product to decrease price.…”
Section: Introductionmentioning
confidence: 99%