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Comparing lanbotulinumtoxinA (Hengli®) with onabotulinumtoxinA (Botox®) and incobotulinumtoxinA (Xeomin®) in the mouse hemidiaphragm assay.
J Neural Transm (Vienna). 2019 Dec; 126(12):1625-1629.JN

Abstract

LanbotulinumtoxinA (LAN) is manufactured and registered in China since 1994. Despite its widespread use in China and its increasing use in other Asian countries and in South America, it is not yet well known elsewhere. We wanted to compare its potency labelling using the mouse diaphragm assay (MDA), an isolated muscle model for botulinum toxin (BT) potency measurements, which is superior to clinical tests and which was recently refined as an alternative batch release assay for BT manufacturing. We also wanted to estimate LAN manufacturing quality by testing its inter-batch potency consistency. Potencies of 20, 60 and 100 MU of LAN, onabotulinumtoxinA (ONA) and incobotulinumtoxinA (INCO) were measured by the inversely related paresis time (PT) in the MDA. The PT (M ± SD) of all doses of LAN, ONA and INCO was 90.4 ± 27.0 min, 114.9 ± 46.5 min and 94.3 ± 29.9 min, respectively. Statistical analysis demonstrated indistinguishable potency labelling of LAN and INCO, but revealed a slightly lower potency of ONA compared to LAN and INCO. PT of LAN batch 1 and LAN batch 2 was 86.9 ± 21.2 min and 94.0 ± 32.8 min, respectively (no statistically significant difference), suggesting an adequate LAN manufacturing consistency. The MDA is an appropriate instrument for potency testing of BT drugs, including new ones currently under development. Our results allow comparing therapeutic effects, adverse effects and economics of LAN, ONA and INCO. They also suggest adequate manufacturing consistency of LAN.

Authors+Show Affiliations

Movement Disorders Section, Department of Neurology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany. Department of Neurology, Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai, China.Toxogen, Hannover, Germany.Department of Neurology, Hannover Medical School, Hannover, Germany.Department of Neurology, Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai, China.Movement Disorders Section, Department of Neurology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany. dressler.dirk@mh-hannover.de.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31707463

Citation

Pan, Lizhen, et al. "Comparing lanbotulinumtoxinA (Hengli®) With onabotulinumtoxinA (Botox®) and incobotulinumtoxinA (Xeomin®) in the Mouse Hemidiaphragm Assay." Journal of Neural Transmission (Vienna, Austria : 1996), vol. 126, no. 12, 2019, pp. 1625-1629.
Pan L, Bigalke H, Kopp B, et al. Comparing lanbotulinumtoxinA (Hengli®) with onabotulinumtoxinA (Botox®) and incobotulinumtoxinA (Xeomin®) in the mouse hemidiaphragm assay. J Neural Transm (Vienna). 2019;126(12):1625-1629.
Pan, L., Bigalke, H., Kopp, B., Jin, L., & Dressler, D. (2019). Comparing lanbotulinumtoxinA (Hengli®) with onabotulinumtoxinA (Botox®) and incobotulinumtoxinA (Xeomin®) in the mouse hemidiaphragm assay. Journal of Neural Transmission (Vienna, Austria : 1996), 126(12), 1625-1629. https://doi.org/10.1007/s00702-019-02100-1
Pan L, et al. Comparing lanbotulinumtoxinA (Hengli®) With onabotulinumtoxinA (Botox®) and incobotulinumtoxinA (Xeomin®) in the Mouse Hemidiaphragm Assay. J Neural Transm (Vienna). 2019;126(12):1625-1629. PubMed PMID: 31707463.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparing lanbotulinumtoxinA (Hengli®) with onabotulinumtoxinA (Botox®) and incobotulinumtoxinA (Xeomin®) in the mouse hemidiaphragm assay. AU - Pan,Lizhen, AU - Bigalke,Hans, AU - Kopp,Bruno, AU - Jin,Lingjing, AU - Dressler,Dirk, Y1 - 2019/11/09/ PY - 2019/08/13/received PY - 2019/10/25/accepted PY - 2019/11/11/pubmed PY - 2019/11/11/medline PY - 2019/11/11/entrez KW - Conversion factors KW - Drug comparability KW - Hemidiaphragm assay KW - IncobotulinumtoxinA KW - LanbotulinumtoxinA KW - Manufacturing consistency KW - OnabotulinumtoxinA KW - Potency labelling SP - 1625 EP - 1629 JF - Journal of neural transmission (Vienna, Austria : 1996) JO - J Neural Transm (Vienna) VL - 126 IS - 12 N2 - LanbotulinumtoxinA (LAN) is manufactured and registered in China since 1994. Despite its widespread use in China and its increasing use in other Asian countries and in South America, it is not yet well known elsewhere. We wanted to compare its potency labelling using the mouse diaphragm assay (MDA), an isolated muscle model for botulinum toxin (BT) potency measurements, which is superior to clinical tests and which was recently refined as an alternative batch release assay for BT manufacturing. We also wanted to estimate LAN manufacturing quality by testing its inter-batch potency consistency. Potencies of 20, 60 and 100 MU of LAN, onabotulinumtoxinA (ONA) and incobotulinumtoxinA (INCO) were measured by the inversely related paresis time (PT) in the MDA. The PT (M ± SD) of all doses of LAN, ONA and INCO was 90.4 ± 27.0 min, 114.9 ± 46.5 min and 94.3 ± 29.9 min, respectively. Statistical analysis demonstrated indistinguishable potency labelling of LAN and INCO, but revealed a slightly lower potency of ONA compared to LAN and INCO. PT of LAN batch 1 and LAN batch 2 was 86.9 ± 21.2 min and 94.0 ± 32.8 min, respectively (no statistically significant difference), suggesting an adequate LAN manufacturing consistency. The MDA is an appropriate instrument for potency testing of BT drugs, including new ones currently under development. Our results allow comparing therapeutic effects, adverse effects and economics of LAN, ONA and INCO. They also suggest adequate manufacturing consistency of LAN. SN - 1435-1463 UR - https://www.unboundmedicine.com/medline/citation/31707463/Comparing_lanbotulinumtoxinA_(Hengli®)_with_onabotulinumtoxinA_(Botox®)_and_incobotulinumtoxinA_(Xeomin®)_in_the_mouse_hemidiaphragm_assay L2 - https://doi.org/10.1007/s00702-019-02100-1 DB - PRIME DP - Unbound Medicine ER -
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