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Pharmaceutical and Biotechnology Industry

The company's ion exchange resin products have obtained certifications for the ISO9001:2000 International Quality Management System, ISO14001:2004 Environmental Management System, and GB/T28001-2001 Occupational Health and Safety Management System. It has also received the Recommended Network Access Product Certificate issued by the Ministry of Electric Power. The company operates a dedicated R&D center and maintains close collaborative relationships with multiple domestic research institutes. Several new products have already completed their experimental development phases.

 

Pharmaceutical and Biotechnology Industry

Application Background

The pharmaceutical and biotechnology industries have extremely high requirements for product purity and safety. In the processes of drug synthesis and the preparation of biological products (vaccines, proteins, antibiotics), it is necessary to remove impurities from raw materials (such as heavy metals, residual solvents, and byproducts) and separate and purify the target product to ensure drug efficacy and patient safety. Traditional separation and purification processes (such as distillation and filtration) suffer from low efficiency, insufficient purity, and high risk of contamination. Ion exchange resins, with their high selectivity and mild separation conditions, have become the core purification material in this industry.

Application Effects

1. After drug purification, the impurity content is ≤0.1%, and the heavy metal residue is lower than the pharmacopoeia limit (e.g., lead ≤0.001%), resulting in a significant improvement in product purity and efficacy.

2. Biological products (such as proteins and vaccines) retain more than 95% of their activity, solving the problem of denaturation and inactivation caused by traditional processes;

3. The separation and purification steps are simplified by 30%, production efficiency is increased by 40%, and the unit product production cost is reduced by 25-30%.

4. The production process complies with GMP standards, and the products have passed quality inspection and certification, significantly enhancing their market competitiveness.

Application Cases

A biopharmaceutical company producing recombinant human insulin had a product purity of only 98.2% after purification using traditional processes, with an insulin activity loss of approximately 10%. After introducing our company's specialized protein separation ion exchange resin and optimizing the separation process, the final product purity increased to 99.8%, the activity retention rate reached 96%, production efficiency increased by 35%, and annual output value increased by over 8 million yuan. Simultaneously, the company obtained international pharmacopoeia quality certification and successfully expanded into overseas markets.

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