Feasibility of antibody-poly(glutamic acid) complexes: preparation of high-concentration antibody formulations and their pharmaceutical properties.
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Feasibility of antibody-poly(glutamic acid) complexes: preparation of high-concentration antibody formulations and their pharmaceutical properties.
High concentration antibody formulation development for subcutaneous administration the remains challenging. More recently, a precipitation-redissolution method is proposed to prepare a suspension or deposition of salt-morbidly protein-poly (amino acid) complex. To explain the usefulness of this method for therapeutic proteins, we investigated the feasibility of the method of precipitation-redissolution using poly (amino acids) for the formulation of high concentration antibody. Omalizumab and adalimumab formulation of 150 mg / mL can be prepared using acid poly-l-glutamate (polye) of low concentration stock solution.
Enzyme-linked immunosorbent assay, circular dichroism, and size-exclusion chromatography revealed that the formation of antibody-polye complex process and precipitation-redissolution does not significantly affect the immunoreactivity or secondary structure of the antibody. Redissolution-precipitation method is less time consuming and more effective than the lyophilization-redissolution, evaporation-redissolution, and ultrafiltration from the standpoint of the final outcome. Scalability is confirmed from 400 uL to 1.0 L. general toxicity and pharmacokinetic profile of the antibody-polye complex formulation that is similar to conventional antibody formulation.
These results indicate that the precipitation-redissolution method using poly (amino acids) has great potential as a method for the concentration of antibody formulation and use of drugs. Oxidation of methionine residues is one of the damaged well known in the monoclonal antibody (mAb) therapy. Because oxidation of methionine can affect the efficacy and pharmacokinetic profiles of their level of oxidation should be strictly controlled during the period of their storage.
In this study, we observed that when antibody therapy is filled into syringes cyclo olefin-based polymers and stored in blister packs with oxygen absorbent, the production of methionine oxidation under thermal stress or light suppressed because of a decrease in dissolved oxygen concentration. Also unexpected, smaller amounts of high molecular weight species and acidic variants of antibodies produced under thermal or light pressure.
Feasibility of antibody-poly(glutamic acid) complexes: preparation of high-concentration antibody formulations and their pharmaceutical properties.
Is the in vitro whole blood cytokine assays useful for detecting potential risks of severe infusion reactions monoclonal antibody drugs?
After a life threatening cytokine release syndrome (CRS) occurred in clinical studies of anti-CD28 monoclonal antibody (mAb) TGN1412, in vitro cytokine release test using human blood cells have been proposed for the non-clinical evaluation of the potential risk of CRS. Two basic assay format that is often used: human peripheral blood mononuclear cells (PBMC) with mAbs move, and whole blood with watery mAbs.
However, the suitability of whole blood cytokine assay (WBCA) has been questioned, because the sample size is not realistic to be needed to detect potential risks caused by TGN1412 CRS, which has a low sensitivity. We do WBCA using peripheral blood obtained from 68 healthy volunteers to compare the two mAbs high risk, analog TGN1412 superagonistic anti-CD28 mAb (CD28SA) and alemutuzumab FcγR-mediated, with low risk mAb, panitumumab.
Recombinant Advanced Glycosylation End Product Specific Receptor (AGER)
Description: A competitive ELISA for quantitative measurement of Human Advanced Glycosylation End Product Specific Receptor in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Human Advanced Glycosylation End Product Specific Receptor ELISA kit
Description: A competitive ELISA for quantitative measurement of Human Advanced Glycosylation End Product Specific Receptor in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Human Advanced Glycosylation End Product Specific Receptor ELISA kit
Description: A competitive ELISA for quantitative measurement of Human Advanced Glycosylation End Product Specific Receptor in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Human Advanced Glycosylation End Product Specific Receptor ELISA Kit
Description: A sandwich quantitative ELISA assay kit for detection of Human Advanced Glycosylation End Product Specific Receptor (AGER) in samples from serum, plasma, tissue homogenates, cell lysates, cell culture supernates or other biological fluids.
Human Advanced Glycosylation End Product Specific Receptor (AGER) ELISA Kit
Description: A sandwich quantitative ELISA assay kit for detection of Human Advanced Glycosylation End Product Specific Receptor (AGER) in samples from serum, plasma, tissue homogenates, cell lysates, cell culture supernates or other biological fluids.
Human Advanced Glycosylation End Product Specific Receptor (AGER) ELISA Kit
Description: This is Double-antibody Sandwich Enzyme-linked immunosorbent assay for detection of Human Advanced Glycosylation End Product Specific Receptor (AGER) in serum, plasma, tissue homogenates, cell lysates, cell culture supernates and other biological fluids.
Human Advanced Glycosylation End Product Specific Receptor (AGER) ELISA Kit
Description: This is Double-antibody Sandwich Enzyme-linked immunosorbent assay for detection of Human Advanced Glycosylation End Product Specific Receptor (AGER) in serum, plasma, tissue homogenates, cell lysates, cell culture supernates and other biological fluids.
Human Advanced Glycosylation End Product Specific Receptor (AGER) ELISA Kit
Description: This is Double-antibody Sandwich Enzyme-linked immunosorbent assay for detection of Human Advanced Glycosylation End Product Specific Receptor (AGER) in serum, plasma, tissue homogenates, cell lysates, cell culture supernates and other biological fluids.
Human Advanced Glycosylation End Product Specific Receptor (AGER) ELISA Kit
Description: This is Double-antibody Sandwich Enzyme-linked immunosorbent assay for detection of Human Advanced Glycosylation End Product Specific Receptor (AGER) in serum, plasma, tissue homogenates, cell lysates, cell culture supernates and other biological fluids.
Human Advanced Glycosylation End Product Specific Receptor (AGER) ELISA Kit
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Human Advanced Glycosylation End Product Specific Receptor (AGER) ELISA Kit
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Description: A competitive ELISA for quantitative measurement of Rat Advanced Glycosylation End Product Specific Receptor in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Rat Advanced Glycosylation End Product Specific Receptor ELISA kit
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Goat Advanced Glycosylation End Product Specific Receptor ELISA kit
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Pig Advanced Glycosylation End Product Specific Receptor ELISA kit
Description: A competitive ELISA for quantitative measurement of Porcine Advanced Glycosylation End Product Specific Receptor in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Pig Advanced Glycosylation End Product Specific Receptor ELISA kit
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Rat Advanced Glycosylation End Product Specific Receptor (AGER) Protein
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Rabbit Advanced Glycosylation End Product Specific Receptor ELISA kit
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Rabbit Advanced Glycosylation End Product Specific Receptor ELISA kit
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Description: A competitive ELISA for quantitative measurement of Monkey Advanced Glycosylation End Product Specific Receptor in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Monkey Advanced Glycosylation End Product Specific Receptor ELISA kit
Description: A competitive ELISA for quantitative measurement of Monkey Advanced Glycosylation End Product Specific Receptor in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Pigeon Advanced Glycosylation End Product Specific Receptor ELISA Kit
Based on cytokine measurements in this study, the sample size required to detect a statistically significant increase in cytokine with 90% power and 5% significance is determined to be n = 9 for CD28SA and n = 5 for alemtuzumab. The most sensitive marker is IL-8. The results showed that the WBCA is the design of a practical test that can warn of potential risks alemtuzumab FcγR-mediated and T-cell activating CD28SA but, as there appears to lower response to CD28SA, it can not be used as a risk-rating.
