Find Rovalpituzumab Tesirine manufacturers, exporters & distributors on PharmaCompass

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Chemistry

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Also known as: Rova-t, Rovalpituzumab-tesirin, Unii-p256hb60ff, Rovalpituzumab tesirine [inn], P256hb60ff, Rovalpituzumab tesirine [who-dd]
Molecular Formula
C78H108N10O25S
Molecular Weight
1617.8  g/mol
InChI Key
NQUUPTGRJYIXSL-YPDXTJLXSA-N

Rovalpituzumab Tesirine
Rovalpituzumab Tesirine is an antibody-drug conjugate (ADC) containing a humanized IgG1 monoclonal antibody (MAb) directed against the delta-like protein 3 (DLL3), conjugated to the cytotoxic pyrrolobenzodiazepine (PBD) dimer D6.5 (SC-DR002) via a maleimide-containing linker with an eight-carbon polyethylene glycol spacer and a cathepsin B-cleavable valine-alanine dipeptide, with potential antineoplastic activity. The MAb moiety of rovalpituzumab tesirine selectively binds to DLL3 on tumor cell surfaces. Upon internalization of the ADC, the dipeptide linker is cleaved and D6.5 is released. Then the imine groups of the PBD moiety bind to the N2 positions of guanines on opposite strands of DNA. This induces DNA strand breaks, inhibits DNA replication, leads to G2/M cell cycle arrest, induces cell death, and inhibits the proliferation of DLL3-overexpressing tumor cells. DLL3, a membrane protein that binds to Notch receptors and regulates Notch-mediated signaling and gene transcription, is overexpressed by certain cancers but is rarely expressed by normal, healthy cells.
1 2D Structure

Rovalpituzumab Tesirine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2R)-3-[(3R)-1-[3-[2-[2-[2-[2-[2-[2-[2-[2-[3-[[(2S)-1-[[(2S)-1-[4-[[(6S,6aS)-3-[5-[[(6aS)-2-methoxy-8-methyl-11-oxo-6a,7-dihydropyrrolo[2,1-c][1,4]benzodiazepin-3-yl]oxy]pentoxy]-6-hydroxy-2-methoxy-8-methyl-11-oxo-6a,7-dihydro-6H-pyrrolo[2,1-c][1,4]benzodiazepine-5-carbonyl]oxymethyl]anilino]-1-oxopropan-2-yl]amino]-3-methyl-1-oxobutan-2-yl]amino]-3-oxopropoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethylamino]-3-oxopropyl]-2,5-dioxopyrrolidin-3-yl]sulfanyl-2-aminopropanoic acid
2.1.2 InChI
InChI=1S/C78H108N10O25S/c1-49(2)70(84-68(90)16-21-103-23-25-105-27-29-107-31-33-109-35-36-110-34-32-108-30-28-106-26-24-104-22-17-80-67(89)15-18-85-69(91)43-66(76(85)97)114-48-58(79)77(98)99)72(93)82-52(5)71(92)83-54-13-11-53(12-14-54)47-113-78(100)88-60-42-65(63(102-7)40-57(60)74(95)87-46-51(4)38-61(87)75(88)96)112-20-10-8-9-19-111-64-41-59-56(39-62(64)101-6)73(94)86-45-50(3)37-55(86)44-81-59/h11-14,39-42,44-46,49,52,55,58,61,66,70,75,96H,8-10,15-38,43,47-48,79H2,1-7H3,(H,80,89)(H,82,93)(H,83,92)(H,84,90)(H,98,99)/t52-,55-,58-,61-,66+,70-,75-/m0/s1
2.1.3 InChI Key
NQUUPTGRJYIXSL-YPDXTJLXSA-N
2.1.4 Canonical SMILES
CC1=CN2C(C1)C=NC3=CC(=C(C=C3C2=O)OC)OCCCCCOC4=C(C=C5C(=C4)N(C(C6CC(=CN6C5=O)C)O)C(=O)OCC7=CC=C(C=C7)NC(=O)C(C)NC(=O)C(C(C)C)NC(=O)CCOCCOCCOCCOCCOCCOCCOCCOCCNC(=O)CCN8C(=O)CC(C8=O)SCC(C(=O)O)N)OC
2.1.5 Isomeric SMILES
CC1=CN2[C@@H](C1)C=NC3=CC(=C(C=C3C2=O)OC)OCCCCCOC4=C(C=C5C(=C4)N([C@H]([C@@H]6CC(=CN6C5=O)C)O)C(=O)OCC7=CC=C(C=C7)NC(=O)[C@H](C)NC(=O)[C@H](C(C)C)NC(=O)CCOCCOCCOCCOCCOCCOCCOCCOCCNC(=O)CCN8C(=O)C[C@H](C8=O)SC[C@@H](C(=O)O)N)OC
2.2 Synonyms
2.2.1 MeSH Synonyms

1. Sc16ld6.5

2. Sc-002

3. Sc002

2.2.2 Depositor-Supplied Synonyms

1. Rova-t

2. Rovalpituzumab-tesirin

3. Unii-p256hb60ff

4. Rovalpituzumab Tesirine [inn]

5. P256hb60ff

6. Rovalpituzumab Tesirine [who-dd]

7. Sc002

8. Rovalpituzumab Tesirine [usan:inn]

9. Sc0002

10. 1613313-09-9

2.3 Create Date
2018-01-14
3 Chemical and Physical Properties
Molecular Weight 1617.8 g/mol
Molecular Formula C78H108N10O25S
XLogP3-1.6
Hydrogen Bond Donor Count7
Hydrogen Bond Acceptor Count28
Rotatable Bond Count53
Exact Mass1616.72078014 g/mol
Monoisotopic Mass1616.72078014 g/mol
Topological Polar Surface Area456 Ų
Heavy Atom Count114
Formal Charge0
Complexity3190
Isotope Atom Count0
Defined Atom Stereocenter Count7
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Treatment of lung carcinoma (small cell and non-small cell carcinoma)


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ABOUT THIS PAGE

Rovalpituzumab Tesirine Manufacturers

A Rovalpituzumab Tesirine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rovalpituzumab Tesirine, including repackagers and relabelers. The FDA regulates Rovalpituzumab Tesirine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rovalpituzumab Tesirine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Rovalpituzumab Tesirine Suppliers

A Rovalpituzumab Tesirine supplier is an individual or a company that provides Rovalpituzumab Tesirine active pharmaceutical ingredient (API) or Rovalpituzumab Tesirine finished formulations upon request. The Rovalpituzumab Tesirine suppliers may include Rovalpituzumab Tesirine API manufacturers, exporters, distributors and traders.

Rovalpituzumab Tesirine GMP

Rovalpituzumab Tesirine Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Rovalpituzumab Tesirine GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Rovalpituzumab Tesirine GMP manufacturer or Rovalpituzumab Tesirine GMP API supplier for your needs.

Rovalpituzumab Tesirine CoA

A Rovalpituzumab Tesirine CoA (Certificate of Analysis) is a formal document that attests to Rovalpituzumab Tesirine's compliance with Rovalpituzumab Tesirine specifications and serves as a tool for batch-level quality control.

Rovalpituzumab Tesirine CoA mostly includes findings from lab analyses of a specific batch. For each Rovalpituzumab Tesirine CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Rovalpituzumab Tesirine may be tested according to a variety of international standards, such as European Pharmacopoeia (Rovalpituzumab Tesirine EP), Rovalpituzumab Tesirine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rovalpituzumab Tesirine USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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