| CAS No.: | 959961-27-4 |
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| Formula: | C110h179n31o40 |
| EINECS: | 959961-27-4 |
| Type: | API |
| Appearance: | Powder |
| Quality: | Pharma Grade |
| Samples: |
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| Customization: |
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Audited Supplier ALM201 is a novel 23-amino acid synthetic peptide to treat solid cancers and identified from the endogenous human protein, FKBPL (FK506 binding protein-like). Initially, the full-length protein was investigated and found to have anti-angiogenic activity using in vitro and ex vivo angiogenesis assays . The sequence responsible for this anti-angiogenic activity was identified using a series of truncated peptides from the protein and found to be a 24-amino acid sequence near the N-terminus. A 24-mer peptide was generated by chemical synthesis matching the identified sequence and assessed in several in vitro, ex vivo, and in vivo experiments. This peptide (termed AD-01) had anti-angiogenic efficacy equivalent to that of the entire protein [14]. However, AD-01 became unstable due to the formation of the inactive pyro-glutamate. A second-generation peptide, ALM201, was manufactured by removing the N-terminal glutamine generating a peptide of similar potency and efficacy to AD-01 in a range of pre-clinical studies, including in vivo tumour xenograft models. The ALM201 peptide was nominated as the clinical candidate.
ALM201 showed promising low picomolar activity in a range of standard in vitro and ex vivo assays that measure angiogenesis and cell migration and invasion . Early investigations into the mechanism of action for ALM201 reported that the peptide is internalised into CD44-expressing cells and targets microtubules inhibiting migration and invasion in cancer and endothelial cells, similar to vascular disrupting agents . However, it was unclear if this was the principal mechanism of inhibiting angiogenesis or if other factors, such as inhibiting endothelial cell migration and invasion following stimulation with multiple growth factors, played a significant role.
ALM201 was not immunogenic and did not cause cytotoxicity or effects on the cell cycle or cell proliferation, suggesting that it would have limited or no off-target effects and that its mode of action was truly anti-angiogenic. Furthermore, ALM201 had significant anti-tumour activity in vivo, as a single agent or in combination with chemotherapeutic agents, in tumour xenograft models (Almac Discovery, manuscript in preparation), making it an attractive agent to take into the clinic.
| Items | Specifications |
| Business Type | We are a manufacturer of GMP peptide and provide OEM service. The lid also can be customized |
| Filling amount | The filling amount is 2-5mg extra per bottle. |
| Purity | The purity is above 99% |
| Price | Competitive price |
| Delivery time | The delivery time is stable and short. If you pay before 12 a.m,the goods can be shipped on the same day. |
| Shipping risk | If the package was lost we will resend the goods to you,so you won't suffer a loss if you buy it. |
Zhaobo Bio acquired early mastery of development and manufacturing of peptides, the short chain amino acids linked by peptide bonds that have enabled new generations of small molecule drugs that closely mimic the body's natural pathways.
Now Zhaobo Bio possesses first-class capabilities to manufacture peptides at industrial scale and in full compliance with the strictest Good Manufacturing Practice (GMP) standards.
Upstream peptide synthesis
Zhaobo Bio production plants are endowed with state-of-the-art equipment for solvent supply, peptide synthesis, purification and isolation of active ingredients and intermediates. All equipment and containment is GMP qualified and cleaning validated. Overlapping capacities and sizes of different equipment trains facilitate a smooth scale-up for increases in demand within the product life cycle.
Downstream purification and isolation of peptides
Zhaobo Bio is committed to the systematic expansion and modernization of its purification equipment in order to ensure the efficient production of ever-increasing amounts of bulk peptide pharmaceuticals.
It uses sophisticated methods for large scale purification campaigns such as preparative high performance liquid chromatography (HPLC), ion exchange (IEX), size-exclusion chromatography (SEC), and ultra-filtration (UF/TFF). The equipment in place permits highly efficient or even continuous manufacturing of extremely pure products up to multi-kg quantities per lot.
For preparative HPLC, dynamic axial compression (DAC) stainless steel columns of up to 60 cm diameter both in batch and continuous mode are packed with the appropriate high performance silica separation phase. For low-pressure chromatography columns up to 80 cm diameter are available. Solvent delivery is ensured from eluent tank farms and containers.
The control of microbiological contamination is a prerequisite for API manufacturing. Class D (ISO 8) and C (ISO 7) clean rooms are supplied via HEPA-filtered, temperature and humidity controlled air, down-flow booths are used for minimizing microbial contamination and protecting operators. Highly active pharmaceutical ingredients are handled in integrated safety workbenches or flexible isolators reaching OEB level 4 (1-10 µg/m3).
Predefined physicochemical properties of the API can only be achieved by a carefully controlled isolation process. Besides precipitation and crystallization, lyophilization of intermediates and final API is a standard unit operation. LaixingPharma have multiple lyophilizers in different sizes (up to 300 liters) located in clean rooms.
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