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Cellular Biology in Tissue Engineering
Published in Joseph W. Freeman, Debabrata Banerjee, Building Tissues, 2018
Joseph W. Freeman, Debabrata Banerjee
Before going into the clinical uses of hematopoietic growth factors, it may be useful to understand their biological actions. These factors are a class of growth factors that are responsible for the growth of blood cells and bone marrow proliferation. These hematopoietic growth factors are a diverse set of hormones with effects on hematopoietic lineages at various points in their developmental cycle.72 So far, they have entered clinical trials and have displayed encouraging results clinical situations. Currently, phase II and III clinical trials are trying to use these factors, either alone or in combinations, to modify disease states and to eradicate many of the side effects associated with other therapeutic agents, such as cytotoxic anticancer agents.72 Many other disease states can also be treated with these growth factors in a similar fashion. Not all hematopoietic growth factors have been studied in humans thus far. However, they show great promise because of the positive results provided from the other related growth factors. Some of these factors are used to clinically mobilize peripheral blood stem cells prior to harvesting the stem cells for transplantation (e.g., granulocyte colony-stimulating factor [GCSF] either alone or in combination with granulocyte macrophage colony-stimulating factor [GMCSF] is used to mobilize CD34+ peripheral blood stem cells).
Applications of Biotechnology: Biology Doing Chemistry
Published in Richard J. Sundberg, The Chemical Century, 2017
Granulocyte colony stimulating factor (G-CSF) stimulates production of neutrophils and is used to counteract neutropenia (reduced white blood cells) associated with cancer chemotherapy. Human G-CSF is a 174 AA polypeptide that is partially glycosylated in its natural state, although this is not required for activity. Three variants are currently in use, Filgrastrim, Lenograstim, and Pegfilgrastim. Filgastim was first approved in 1991. It is produced in E. coli and contains a terminal methionine. Lenograstim is produced in a hamster ovary cell-line and is glycosylated. Pegfilgrastim is a modified peptide having a PEG chain that slows clearance through the kidneys and increases its half-life. The PEG chain is introduced on the N-terminus by chemical methodology.
Pulmonary reactions to novel chemotherapeutic agents and biomolecules
Published in Philippe Camus, Edward C Rosenow, Drug-induced and Iatrogenic Respiratory Disease, 2010
Granulocyte colony-stimulating factor (G–CSF) is a haematopoietic growth factor that is used to stimulate neutrophil recovery following chemotherapy-induced myelosuppression. Although G–CSF is generally safe and well tolerated, there have been a number of reports of acute lung injury (ALI) or ARDS when it is used in combination with chemotherapeutic agents with known lung toxicity, including bleomycin, busulfan, cyclophosphamide and methotrexate.33,34 Susceptibility to this type of pulmonary adverse effect may be linked to human leucocyte antigens (HLA) B51 and B52.34 Most patients have received at least three courses of chemotherapy, suggesting that repeated endothelial damage by chemotherapy agents enhances G–CSF-induced alveolar inflammation.33,35 The treatment approach is discontinuation of G–CSF with or without addition of corticosteroids, and the mortality rate is 25 per cent. Interstitial pneumonitis also has been described,33,36 as have isolated exudative pleural effusions.37
Bioprocessing of recombinant proteins from Escherichia coli inclusion bodies: insights from structure-function relationship for novel applications
Published in Preparative Biochemistry & Biotechnology, 2023
Kajal Kachhawaha, Santanu Singh, Khyati Joshi, Priyanka Nain, Sumit K. Singh
To simplify the above mentioned issues, researchers have attempted to express the target proteins as a particular class of IBs referred to as non-classical IBs. In contrast to the classical IBs, the non-classical IBs are relatively less dense and often contain a small fraction of bioactive proteins.[42] The non-classical IBs require relatively very mild solubilization conditions. Active 3D correctly folded proteins can be obtained directly from diluting solubilized proteins without requiring additional refolding and purification steps.[43] For example, Trinh et al. reported a feasible E. coli-based expression platform for granulocyte colony-stimulating factor (GCSF) production at low temperatures in the form of non-classical IBs. With the said approach, the GCSF was expressed, IBs were effectively isolated, solubilized under very mild conditions, and refolded into native form by dilution.[44]
Regulatory considerations in biosimilars: Middle East and Africa regions
Published in Preparative Biochemistry & Biotechnology, 2021
Anurag S. Rathore, Ankita Bhargava
In MEA regions, biosimilars for insulin, interferon, Human Growth Hormone (HGH), and Granulocyte colony-stimulating factor (GCSF) form the bulk of the market, with GCSF biosimilars having the maximum share. The introduction of biosimilars in the MEA regions has improved the accessibility of these products to the patients. Further, biosimilars have significantly contributed to making this class of products affordable. For example, net prices of innovator products have come down by 18% to $288.52 for bevacizumab (a 100 mg vial), 45% to $39.34 for interferon-beta (30-microgram prefilled syringe), and 14% to $$249.17 for rituximab (500 mg vial).[3] The MEA biosimilars market was valued at $344.8 million in 2018 and is projected to reach $2,091.0 million by 2025, growing at a compound annual growth rate (CAGR) of 29.8% during the forecast period 2018 to 2025. It is expected that demand will continue to increase significantly over the next few years.[4] Many biopharma manufacturers are entering the African biosimilar market. Biocad (a Russian biotech company) has partnered with M/s Sothema to make biosimilars in North Africa. Under this agreement, Biocad will transfer drug substances for its biosimilar versions of Roche’s Rituximab/Mabthera and Avastin (Bevacizumab) to Sothema’s 11,000 m2 facility in Casablanca.[5]
Challenges and advancements in the pharmacokinetic enhancement of therapeutic proteins
Published in Preparative Biochemistry & Biotechnology, 2021
Farnaz Khodabakhsh, Morteza Salimian, Mohammad Hossein Hedayati, Reza Ahangari Cohan, Dariush Norouzian
PEG mimetic peptides are different in the amino acid type and the number of repeats. At first, the sequence of such repeats was derived from natural proteins such as gelatin and elastin. Gelatin-like polymers are obtained from collagen hydrolysis and contain G-X-Y repeats, in which X and Y are often proline and hydroxyproline, respectively. This sequence because of random coil conformation and the hydrophilic nature displays a high hydrodynamic radius. It was reported that the genetic fusion of granulocyte-colony stimulating factor (G-CSF) to four identical 16-residue fragments of GLK increases the plasma half-life of fused protein approximately 10 h (five-fold) when administered subcutaneously to Sprague-Dawley rats.[49] This effect was also observed for elastin-like polymers (ELP) that are composed of VPGXG repeats, in which X is any amino acid other than proline.[50] However, these natural-derived amino acid sequences had different deleterious effects on the target protein in vitro and in vivo. For example, in one study, ELP fusion leads to protein aggregation at 32 °C, which is close to body temperature. Similarly, a decrease in the biological activity of IL-1 receptor antagonist has been observed, leading to an increase in IC50 value and destruction under intracellular proteases.[51]