| Customization: | Available |
|---|---|
| Purity HPLC: | ≥99.0% |
| Sequence: | {Eicosanedioic Acid-γ-Glu}-Kcn |
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Cagrilintide
GENERIC PEPTIDES (GMP)
cGMP peptides Manufacturing
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 (cGMP) 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.
ZhaoboBio's Peptide Plant also manufactures and offers a range of specialized services for the cGMP Small Molecules.
Small molecule production capabilities include: process development, chiral synthesis, heterocyclic chemistry, metal-catalyzed reactions, hydrogenations, oxidations and reductions using various reagents, enzymatic reactions, and high pressure reactions.
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