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Arginine, with its unique chemical properties and multiple mechanisms of action, has been widely used in the field of biopharmaceuticals, from being an initial protein refolding aid to becoming a core component of high concentration formulations today. As of now, arginine has been used for20Among the approved protein drug injection formulations, there are17It is a monoclonal antibody preparation. Among these monoclonal antibody preparations, there are11High concentration (≥)100 mg/mL)Antibody preparations contain arginine or arginine hydrochloride, highlighting the crucial role of arginine in high concentration formulations. Arginine and arginine hydrochloride have various important applications in biopharmaceuticals, including:
1. Enhance protein refolding and solubility
The guanidine group of arginine can interact with the π electrons of aromatic amino acid side chains, effectively inhibiting protein aggregation during refolding, thereby improving refolding efficiency and facilitating the refolding and solubilization of recombinant proteins.
2. Stabilize proteins and inhibit aggregation
Arginine and arginine hydrochloride can significantly improve the photostability and thermal stability of proteins by inhibiting hydrophobic and electrostatic interactions between protein molecules, reducing protein aggregation, and enhancing the stability of protein formulations.
3. Reduce the viscosity of high concentration formulas
Arginine can reduce the viscosity of high concentration protein preparations, which is particularly important for subcutaneous administration of high concentration protein preparations.
4. Reduce non-specific surface adsorption
Arginine can effectively prevent protein adsorption on commonly used materials such as polystyrene particles, reducing protein loss and denaturation.
5. Adjust the osmotic pressure of the solution
Arginine hydrochloride can regulate the osmotic pressure of biopharmaceutical formulations to match the physiological environment of the human body, reducing discomfort and tissue irritation during injection.
6. As a freeze-drying protectant
In freeze-dried formulations, both arginine and arginine hydrochloride exhibit good cryoprotective effects, maintaining the hydration layer of proteins, preventing conformational changes caused by dehydration, and improving the reconstitution efficiency and stability of freeze-dried products.
7. Assisted protein purification
In the process of antibody purification, arginine and arginine hydrochloride can be used as mobile phase additives to promote the elution of target proteins, reduce the adsorption of impurities, and improve purification efficiency.
PfanstiehlArginineA-170Compared with arginine hydrochlorideA-171It is developed specifically for injectable biomacromolecule drugs, with ultra-high purity, ultra-low endotoxin, ultra-low metal ion content, and high-quality injection grade excipients that comply with multiple pharmacopoeias. Whether it is global declaration or the development of increasingly complex biopharmaceutical formulations,PfanstiehlThey can all provide solid guarantees.
PfanstiehlArginineA-170Compared with arginine hydrochlorideA-171The advantages mainly include the following aspects:
Complies with USP, EP, JP, ChP multi country pharmacopoeias;
Ultra high purity, ultra-low endotoxin, ultra-low microbial content;
Ultra low metal residue,29Detect metal ions separately, all as low asppbLevel;
Detecting residues of lipase, protease, and phosphatase;
detectionDNATheRNATheDNaseTheRNaseresidual;
Detecting nitrite residues;
Detecting β-Glucansresidual;
DMF/CDE filing, arginineCDEstatusA;
can provide1kg,5kg,10kg,25kg,50kgMultiple packaging specifications to meet the flexible needs of drugs at various stages from research and development to market launch.
Product Information
Product Name |
CASnumber |
Item Number |
Pharmacopoeia compliance |
DMF |
CDERegistration Number |
CDE status |
|
L-Arginine Arginine |
74-79-3 |
A-170 |
USP, EP, JP, ChP |
19116 |
F20190000412 |
A |
|
L-Arginine HCl Arginine hydrochloride |
1119-34-2 |
A-171 |
USP, EP, JP, ChP |
38077 |
F20220000100 |
I |
PfanstiehlArginineA-170Compared with arginine hydrochlorideA-171In the hot selling spot market,If you are interested in the above products, please feel free to contact usPfanstiehlBeijing Ximeijie Technology Co., Ltd., the agent in China, has obtained a detailed product overview documentApply for testing samples.

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