Delving into the Latest Updates on Recombinant Human Serum Albumin(Protgen Ltd.) with Synapse

Overview

Basic Info

Drug Type

Recombinant protein

Synonyms

Recombinant human serum albumin biosimilar(Protgen)

Target

albumin

Action

modulators

Mechanism

albumin modulators(Serum albumin modulators), Immunomodulators

Therapeutic Areas

Digestive System DisordersOther DiseasesCardiovascular Diseases+ [5]

Active Indication

AscitesLiver CirrhosisCirrhotic Cardiomyopathy+ [8]

Inactive Indication

Fibrosis

Originator Organization

ProTgen, Inc.

Active Organization

ProTgen, Inc.

Shenzhen Projee Medical Technology Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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This clinical trial is an open-label, parallel-group, exploratory study of recombinant human serum albumin (rHSA, hereafter referred to as the "investigational drug") in patients with mild to moderate Alzheimer's Disease (AD). It aims to enroll 30 subjects who meet the 2011 National Institute on Aging and Alzheimer's Association (NIA-AA) criteria for "Probable AD Dementia." Participants will be randomized in a 1:1:1 ratio to receive the investigational drug at doses of 20g, 30g, or 40g, for assessments of safety and preliminary efficacy. Stratification factors will be based on the severity classification (mild; moderate) as indicated by the total score on the Clinical Dementia Rating Scale - Global Score (CDR-GS) during the screening period.

Start Date28 Jun 2024

Sponsor / Collaborator

ProTgen, Inc.

NCT05858853

/ CompletedPhase 2/3

To Evaluate the Effectiveness of Recombinant Human Serum Albumin Versus Human Serum Albumin in Patients With Hepatic Cirrhosis and Safety of Random, Double-blind, Parallel Grouping Phase II/III Clinical Trial

This is a randomized, double-blind, position-controlled, parallel group phase II/III clinical study of recombinant human serum albumin (rHSA) in cirrhotic ascites patients.

Start Date25 May 2023

Sponsor / Collaborator

ProTgen, Inc.

100 Clinical Results associated with Recombinant Human Serum Albumin(Protgen Ltd.)

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100 Translational Medicine associated with Recombinant Human Serum Albumin(Protgen Ltd.)

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100 Patents (Medical) associated with Recombinant Human Serum Albumin(Protgen Ltd.)

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5

Literatures (Medical) associated with Recombinant Human Serum Albumin(Protgen Ltd.)

14 Aug 2017·ACS Biomaterials Science & EngineeringQ3 · ENGINEERING & TECHNOLOGY

Engineering Xeno-Free Microcarriers with Recombinant Vitronectin, Albumin and UV Irradiation for Human Pluripotent Stem Cell Bioprocessing

Q3 · ENGINEERING & TECHNOLOGY

Article

Author: Fan, Yongjia ; Zhang, Fan ; Tzanakakis, Emmanuel S.

The development of platforms for the expansion and directed differentiation of human pluripotent stem cells (hPSCs) in large quantities under xeno-free conditions is a key step toward the realization of envisioned stem cell-based therapies. Microcarrier bioreactors afford great surface-to-volume ratio, scalability and customization with typical densities of 10⁶-10⁷ cells/ml or higher. In this study, a simple and inexpensive method was established for generating microcarriers without animal-derived components. While coating polystyrene beads with vitronectin alone did not support the culture of hPSCs in stirred suspension, the inclusion of recombinant human serum albumin and UV irradiation led to enhanced seeding efficiency and retention while cells grew more than 20-fold per passage for multiple successive passages and without loss of cell pluripotency. Human PSCs expanded on microcarriers were coaxed to tri-lineage differentiation demonstrating that this system can be used for the self-renewal and specification of hPSCs to therapeutically relevant cell types. Such systems will be critical for the envisioned use of stem cells in regenerative medicine and drug discovery.

01 Sep 2016·Applied Microbiology and BiotechnologyQ3 · ENGINEERING & TECHNOLOGY

Expression and bioactivity of recombinant human serum albumin and dTMP fusion proteins in CHO cells

Q3 · ENGINEERING & TECHNOLOGY

Article

Author: Guo, Dingding ; Wang, Haiqing ; Wang, Na ; Che, Jingmin ; Li, Hongyu ; Wang, Yong ; Ru, Yi ; Wei, Suzhen ; Zhi, Dejuan ; Wang, Meizhu ; Li, Yang

The 14-amino acid (IEGPTLRQWLAARA) thrombopoietin mimetic peptide (TMP) shares no sequence homology with native thrombopoietin (TPO). When dimerized, it displays a high-binding affinity for the TPO receptor and has equipotent bioactivity with recombinant human TPO (rhTPO) in stimulating proliferation and maturation of megakaryocytes in vitro. However, TMP is limited for clinical usage because of its short half-life in vivo. In this study, fusion proteins that composed of tandem dimer of TMP (dTMP) genetically fused at the C- or N-terminus of human serum albumin (HSA) were separately expressed in Chinese hamster ovary (CHO) cells. In vitro bioactivity assays showed that purified fusion proteins promoted the proliferation of megakaryocytes in a dose-dependent manner and activated signal transducer and activator of transcription (STAT) pathway in TPO receptor-dependent manner. Following subcutaneous administration, both HSA-dTMP and dTMP-HSA significantly elevated peripheral platelet counts in normal mice in a dose-dependent manner. In addition, fusion with HSA successfully prolonged dTMP half-life in mice. However, when HSA was fused at the C-terminus of dTMP, the bioactivity of dTMP-HSA was about half of that of HSA-dTMP. In conclusion, these results suggested that HSA/dTMP fusion proteins might be potential drugs for thrombocytopenia and, when HSA was fused at the N-terminus of dTMP, the fusion protein had a higher activity.

01 Jan 2016·Journal of Reproduction and DevelopmentQ4 · BIOLOGY

Lipid-rich bovine serum albumin improves the viability and hatching ability of porcine blastocysts produced <i>in vitro</i>

Q4 · BIOLOGY

Article

Author: YOSHIOKA, Koji ; HOSHI, Hiroyoshi ; SUZUKI, Chie ; SAKAGUCHI, Yosuke

The effects of lipid-rich bovine serum albumin (LR-BSA) on the development of porcine blastocysts produced in vitro were examined. Addition of 0.5 to 5 mg/ml LR-BSA to porcine blastocyst medium (PBM) from Day 5 (Day 0 = in vitro fertilization) significantly increased the hatching rates of blastocysts on Day 7 and the total cell numbers in Day-7 blastocysts. When Day-5 blastocysts were cultured with PBM alone, PBM containing LR-BSA, recombinant human serum albumin or fatty acid-free BSA, addition of LR-BSA significantly enhanced hatching rates and the cell number in blastocysts that survived compared with other treatments. The diameter, ATP content and numbers of both inner cell mass and total cells in Day-6 and Day-7 blastocysts cultured with PBM containing LR-BSA were significantly higher than in blastocysts cultured with PBM alone, whereas LR-BSA had no effect on mitochondrial membrane potential. The mRNA levels of enzymes involved in fatty acid metabolism and β-oxidation (ACSL1, ACSL3, CPT1, CPT2 and KAT) in Day-7 blastocysts were significantly upregulated by the addition of LR-BSA. The results indicated that LR-BSA enhanced hatching ability and quality of porcine blastocysts produced in vitro, as determined by ATP content, blastocyst diameter and expression levels of the specific genes, suggesting that the stimulatory effects of LR-BSA arise from lipids bound to albumin.

100 Deals associated with Recombinant Human Serum Albumin(Protgen Ltd.)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cirrhotic Cardiomyopathy	Phase 3	China	ProTgen, Inc.	13 Aug 2024
Ascites	Phase 3	China	Shenzhen Projee Medical Technology Co., Ltd.	09 Aug 2024
Liver Cirrhosis	Phase 3	China	Shenzhen Projee Medical Technology Co., Ltd.	09 Aug 2024
Hepatic ascites	Phase 3	China	ProTgen, Inc.	25 May 2023
Alzheimer Disease	Phase 1	China	ProTgen, Inc.	28 Jun 2024
Advanced cancer	Preclinical	China	ProTgen, Inc.	30 Jan 2022
Hyperbilirubinemia, Neonatal	Preclinical	China	ProTgen, Inc.	30 Jan 2022
Hypoproteinemia	Preclinical	China	ProTgen, Inc.	30 Jan 2022
Shock	Preclinical	China	ProTgen, Inc.	30 Jan 2022
Fibrosis	Discovery	China	ProTgen, Inc.	14 Oct 2021

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Biosimilar

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