Unexplored Excipients in Biotherapeutic Formulations: Natural Osmolytes as Potential Stabilizers Against Thermally Induced Aggregation of IgG1 Biotherapeutics. [PDF]
AAPS PharmSciTech, 2021 Monoclonal antibodies (mAbs), while incredibly successful, are prone to a variety of degradation pathways, the most significant of which is aggregation. One of the most commonly used strategy to overcome protein aggregation is addition of excipients to the formulation. Osmolytes such as trehalose, sucrose, and glycine are widely used. In this paper, we
Bhojane PP +3 more
europepmc +4 more sources
An investigation into the effect of polysorbate 80 grade in biotherapeutic formulations [PDF]
Polysorbate 80 is a commonly used excipient in the food, cosmetics and pharmaceutical industries. In pharmaceutical formulations, the only requirement in the British Pharmacopeia and US Pharmacopeia is for the composition to be ≥ 58% oleic acid ester ...
Gurgul, SJ +3 more
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Batch Culture Formulation of Live Biotherapeutic Products
Advanced Therapeutics, 2020 AbstractLive biotherapeutic products (LBPs) are an emerging therapeutic modality that have been clinically investigated for treating pathogenic infections and inflammatory diseases. A major class of LBPs are feces‐derived microbial consortiums which require numerous process development steps (e.g., separation, purification, blending) to facilitate LBP ...
Kunyu Qiu, Aaron C. Anselmo
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Formulation and delivery solutions for the next generation biotherapeutics
Journal of Controlled Release, 2021 In 2018 I was appointed full professor of Pharmaceutical Biotechnology & Delivery at the Pharmaceutics division of the department of Pharmaceutical Sciences at Utrecht University, The Netherlands. In this contribution to the Orations - New Horizons of the Journal of Controlled Release I will introduce my research group (see also www.uu.nl/pharmaceutics)
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Applications and analysis of hydrolysates in animal cell culture
Bioresources and Bioprocessing, 2021 Animal cells are used in the manufacturing of complex biotherapeutic products since the 1980s. From its initial uses in biological research to its current importance in the biopharmaceutical industry, many types of culture media were developed: from ...
Yin Ying Ho +5 more
doaj +1 more source
A pH-sensitive stearoyl-PEG-poly(methacryloyl sulfadimethoxine)-decorated liposome system for protein delivery: an application for bladder cancer treatment [PDF]
, 2016 Stealth pH-responsive liposomes for the delivery of therapeutic proteins to the bladder epithelium were prepared using methoxy-poly(ethylene glycol)5kDa-1,2-distearoyl-sn-glycero-3-phosphoethanolamine (mPEG5kDa-DSPE) and stearoyl-poly(ethylene glycol ...
Balasso, Anna +8 more
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Antioxidants, 2023 Flavonoids are a biodiverse family of dietary compounds that have antioxidant, anti-inflammatory, antiviral, and antibacterial cell protective profiles.
James Melrose
doaj +1 more source
Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines [PDF]
, 2018 Objective: The aim was to critically evaluate well-established regulatory agencies mAb biosimilar guidelines for development and marketing authorization about quality, efficacy and safety and compare to BRICS-TM regulations to identify challenges ...
Anvisa +20 more
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Probiotics: Finding the Right Regulatory Balance [PDF]
, 2013 Some products marketed as drugs should be excused from Phase I trials, but safety and efficacy claims for dietary supplements should be more tightly ...
C. M. Fraser +6 more
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Emerging trends in 'smart probiotics' : functional consideration for the development of novel health and industrial applications [PDF]
, 2017 The link between gut microbiota and human health is well-recognized and described. This ultimate impact on the host has contributed to explain the mutual dependence between humans and their gut bacteria.
El Hage, Racha +2 more
core +3 more sources