Glatiramoids

Weinstein, Vera; Schwartz, Rivka; Grossman, Iris; Zeskind, Benjamin; Nicholas, J. Michael

doi:10.1007/978-3-319-16241-6_4

Cited by 12 publications

(20 citation statements)

References 124 publications

(222 reference statements)

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“…Recently a generic version marketed as Glatopa was approved by the US-FDA [74], and other generics have been marketed and administered worldwide. Glatimer by Natco Pharma is sold in India and the Ukraine, Probioglat by Probiomed is sold in Mexico, and both Escadra (Raffo Laboratories) and Polimunol GTR (Synthon) are sold in Argentina [75]. Collectively these molecules have been termed glatiramoids [75,76].…”

Section: Increased Complexity: Synthetic Biomaterials Eliciting Mumentioning

confidence: 99%

“…Glatimer by Natco Pharma is sold in India and the Ukraine, Probioglat by Probiomed is sold in Mexico, and both Escadra (Raffo Laboratories) and Polimunol GTR (Synthon) are sold in Argentina [75]. Collectively these molecules have been termed glatiramoids [75,76]. Because they are non-biological complex drugs composed of difficult-to-define randomized mixtures of polyamino acids, the specific biological activity of glatiramoids is highly dependent on their manufacturing processes.…”

Section: Increased Complexity: Synthetic Biomaterials Eliciting Mumentioning

confidence: 99%

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Biomaterial strategies for generating therapeutic immune responses

Kelly

Shores

Votaw

et al. 2017

Advanced Drug Delivery Reviews

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Biomaterials employed to raise therapeutic immune responses have become a complex and active field. Historically, vaccines have been developed primarily to fight infectious diseases, but recent years have seen the development of immunologically active biomaterials towards an expanding list of non-infectious diseases and conditions including inflammation, autoimmunity, wounds, cancer, and others. This review structures its discussion of these approaches around a progression from single-target strategies to those that engage increasingly complex and multifactorial immune responses. First the targeting of specific individual cytokines is discussed, both in terms of delivering the cytokines or blocking agents, and in terms of active immunotherapies that raise neutralizing immune responses against such single cytokine targets. Next, non-biological complex drugs such as randomized polyamino acid copolymers are discussed in terms of their ability to raise multiple different therapeutic immune responses, particularly in the context of autoimmunity. Last, biologically derived matrices and materials are discussed in terms of their ability to raise complex immune responses in the context of tissue repair. Collectively, these examples reflect the tremendous diversity of existing approaches and the breadth of opportunities that remain for generating therapeutic immune responses using biomaterials.

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Section: Increased Complexity: Synthetic Biomaterials Eliciting Mumentioning

confidence: 99%

Section: Increased Complexity: Synthetic Biomaterials Eliciting Mumentioning

confidence: 99%

Biomaterial strategies for generating therapeutic immune responses

Kelly

Shores

Votaw

et al. 2017

Advanced Drug Delivery Reviews

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“…A general strategy was developed to establish equivalence based on the overall scientific understanding of GA chemistry and synthesis process . Characterization of such complex drugs requires many physicochemical techniques to cover a wide range of structural information, including reversed‐phase liquid chromatography (RPLC), hydrophilic interaction liquid chromatography (HILIC), ion‐exchange chromatography, size‐exclusion chromatography, mass spectrometry (MS), capillary isoelectric focusing, and multiangle light scattering …”

Section: Introductionmentioning

confidence: 99%

“…In addition, small changes in the GA mixture can change its immunogenicity profile . As glatiramoids exhibit similar profiles after enzymatic cleavage to shorter fragments, peptide mapping can be used for comparing original and proposed generic drug compositions or other glatiramoids manufactured under different condition…”

Section: Introductionmentioning

confidence: 99%

“…These proteases cleave GA polymeric chains at the carboxyl side of the amino acid lysine. It was shown that due to low detection sensitivity, the capability of RPLC‐UV peptide mapping analysis is not sufficient for indicating small differences in GA composition . Considering the high abundance of lysine in the copolymer composition, the tryptic cleavage sites of GA are too close together.…”

Section: Introductionmentioning

confidence: 99%

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Application of 6‐aminoquinolyl‐N‐hydroxysuccinimidyl carbamate derivatization for enhanced peptide mapping analysis of non‐biological complex drug glatiramer acetate using liquid chromatography/electrospray ionization collision‐induced dissociation high‐resolution mass spectrometry

Mesonzhnik

Kuznetsov

Bochkareva

et al. 2020

Rapid Comm Mass Spectrometry

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Rationale: Glatiramer acetate (GA) (Copaxone ® ) is a non-biological complex drug (NBCD) comprising random-sequence polymer chains of four amino acids (MW~5-9 kDa) with unknown structure. The characterization of NBCDs by reversed-phase liquid chromatography/mass spectrometry (RPLC/MS) peptide mapping is often impeded by insufficient separation and/or low sensitivity. To overcome this issue, pre-column derivatization of GA peptide digest was used to improve RPLC/MS detectability and to generate a comprehensive peptide profile.Methods: Amino groups of peptides generated by trypsin digestion of GA were derivatized using 6-aminoquinolyl-N-hydroxysuccinimidyl carbamate (AQC) reagent.The derivatized mixture of random-sequence peptides was analyzed by liquid chromatography/positive-mode electrospray ionization collision-induced dissociation high-resolution mass spectrometry (RPLC/ESI-CID-HRMS/MS). Data-independent LC/MS E mode was used for data acquisition. Results:The derivatization of the GA peptide mixture increased the detectability of RPLC/ESI-CID-HRMS/MS analysis. The efficacy of the procedure was demonstrated by using selected peptides related to different polymeric chain origins. The resultant peptides were derivatized in a predictable manner giving a minimum of side products.The reproducibility of the developed method was demonstrated by comparing peptide elution profiles derived from six Copaxone ® lots. Conclusions:Application of the AQC pre-column derivatization provides a framework that could be used as an attractive approach for monitoring the quality and characterization of NBCD products in the pharmaceutical industry.

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Capillary zone electrophoresis method for quantification of therapeutic peptide glatiramer acetate

Niaei,

Vališ,

Petr

2024

Monatsh Chem

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This study presents the development and validation of a novel capillary zone electrophoresis method for the precise determination of glatiramer acetate and its amino acid constituents. A 120 mmol dm−3 phosphoric acid solution adjusted to pH 1.9 with Tris, supplemented with 20 mmol dm−3 triethylamine to achieve a final of pH 2.1, resulted in a repeatable analysis of glatiramer acetate. The method demonstrated a limit of detection and quantification of 39.2 µg cm−3 and 130.7 µg cm−3, respectively. This method allows for the rapid control of glatiramer acetate-based pharmaceuticals and distinguishes glatiramer acetate from the amino acids used in its synthesis. Graphical abstract

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Glatiramoids

Cited by 12 publications

References 124 publications

Biomaterial strategies for generating therapeutic immune responses

Biomaterial strategies for generating therapeutic immune responses

Application of 6‐aminoquinolyl‐N‐hydroxysuccinimidyl carbamate derivatization for enhanced peptide mapping analysis of non‐biological complex drug glatiramer acetate using liquid chromatography/electrospray ionization collision‐induced dissociation high‐resolution mass spectrometry

Capillary zone electrophoresis method for quantification of therapeutic peptide glatiramer acetate

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