Pharmaceutical and biotechnology industry
The company's products based on ion exchange resins have received certificates of the International Quality Management System ISO9001: 2000, Environmental Management System ISO14001: 2004 and Occupational Health and Safety Management System GB/T28001-2001. In addition, the company has received a certificate of recommended product for network access issued by the Ministry of Electricity. The company has a specialized research and development center and maintains close cooperative relationships with several domestic research institutes. Several new products have already passed experimental development stages.
General information about application
The pharmaceutical and biotechnology industries place extremely high demands on product purity and safety. In the processes of drug synthesis and preparation of biological products (vaccines, proteins, antibiotics), it is necessary to remove impurities from raw materials (such as heavy metals, residual solvents and by-products), as well as separate and purify the target product to ensure drug effectiveness and patient safety. Traditional separation and purification processes (such as distillation and filtration) are characterized by low efficiency, lack of purity and a high risk of contamination. Ion exchange resins, with their high selectivity and mild separation conditions, have become the main purification material in this industry.
Application effects
1. After drug purification, the impurity content is ≤0.1%, and the heavy metal content is below the pharmacopoeial limit (such as lead ≤0.001%), resulting in a significant increase in the purity and potency of the product.
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. Separation and purification steps are simplified by 30%, production efficiency is increased by 40%, and unit cost is reduced by 25-30%.
4. The production process complies with GMP standards, and the products have passed quality inspection and certification, which greatly improves its competitiveness in the market.
Application examples
For a biopharmaceutical company producing recombinant human insulin, the purity of the product after purification by traditional methods was only 98.2%, and insulin activity was reduced by approximately 10%. After introducing our company's specialized ion exchange protein separation resin and optimizing the separation process, the purity of the final product increased to 99.8%, the activity retention rate reached 96%, the production efficiency increased by 35%, and the annual production volume increased by more than 8 million RMB. At the same time, the company received an international pharmacopoeia quality certificate and successfully entered foreign markets.
