[PDF][PDF] Toxicity and immunogenicity concerns related to PEGylated-micelle carrier systems: a review

K Shiraishi, M Yokoyama - Science and technology of advanced …, 2019 - Taylor & Francis
… immunological issues owing to rapid blood clearance of PEGylated nanoparticles (…
PEGylated biopharmaceuticals: current experience and considerations for nonclinical development

Intraocular delivery considerations of ocular biologic products and key preclinical determinations

P Hughes, HM Rivers, V Bantseev… - Expert Opinion on …, 2023 - Taylor & Francis
… This review describes the current development status of intravitreally administered drugs for
… the eye, and discusses key preclinical considerations for the evaluation of ocular biologics. …

Absorption, distribution, metabolism, and excretion of therapeutic proteins: current industry practices and future perspectives

J Bolleddula, K Brady, G Bruin, A Lee, JA Martin… - Drug Metabolism and …, 2022 - ASPET
… Early in preclinical development, the pharmacokinetics of … One example is the PEGylated,
Fc-free antitumor necrosis … the behavior of the biopharmaceutical and the possible influence of …

Manufacturing of the Drug Product

J Geigert, J Geigert - … CMC Regulatory Compliance for Biopharmaceuticals, 2019 - Springer
PEGylated biopharmaceuticals. The following commercial … Nonclinical data suggest that the
anticancer activity of … the drug product, taking into consideration intended usage and route of …

[图书][B] Biopharmaceuticals: challenges and opportunities

B Behera - 2020 - taylorfrancis.com
… It has been experienced that biopharmaceutical manufacturing … , PEGylation (pegylation)
or molecular biology techniques are used to enhance the potential of biobetters. In PEGylation, …

Research progress on the PEGylation of therapeutic proteins and peptides (TPPs)

C Li, T Li, X Tian, W An, Z Wang, B Han… - Frontiers in …, 2024 - frontiersin.org
issues due to its favorable properties. This review presents recent progress in the development
… to be safe for patients who had previously experienced allergic reactions to E. coli or …

Shifting paradigms revisited: biotechnology and the pharmaceutical sciences

DJA Crommelin, E Mastrobattista, A Hawe… - Journal of …, 2020 - Elsevier
… : “Shifting paradigms: biopharmaceuticals versus low molecular … as it is at present unknown
how the preclinical observations of … One example is the withdrawal of a PEGylated peptide …

Nanopharmaceuticals and nanomedicines currently on the market: challenges and opportunities

F Farjadian, A Ghasemi, O Gohari, A Roointan… - …, 2019 - Future Medicine
… of developing nanopharmaceuticals, the issue of preclinical in … PEGylation of ADA solved
these issues. Davis et al. … hemophilia A in patients who experience repeated bleeding events […

Polyethylene glycol (PEG): The nature, immunogenicity, and role in the hypersensitivity of PEGylated products

M Ibrahim, E Ramadan, NE Elsadek, SE Emam… - Journal of Controlled …, 2022 - Elsevier
biopharmaceuticals while reducing toxicity and improving stability [10,11]. Despite the great
importance of PEGylation… haemophilia A developed anti-PEG antibodies and experienced

PEG–protein conjugates; regulatory requirements for characterization

MJ Bossard - Polymer-Protein Conjugates, 2020 - Elsevier
consideration as a new product. This chapter reviews historical and current regulatory
guidelines specific to PEGylated … The nonclinical safety evaluation of biopharmaceuticals applies …