南宫NG28

Service Background

In biopharmaceutical manufacturing, process-related impurities may come from a variety of raw materials, equipment, and reagent materials introduced during upstream incubation and downstream purification. Since these impurities may affect the quality and safety of the product, their removal during the purification process becomes critical.

Microbiological Detectionproduction Process impurity Study

Purpose of Service

The study of impurities in the manufacturing process is an important guarantee to ensure the safety and efficacy of pharmaceutical products. Through the comprehensive use of modern analytical techniques such as chromatography and mass spectrometry, combined with international guidelines such as ICH, various types of impurities in the production process of pharmaceuticals can be effectively identified and controlled, so as to safeguard the quality of pharmaceuticals and meet the requirements of regulatory agencies. At the same time, genotoxic impurities with potentially high risk require special attention and strict control measures to minimize the potential risk of pharmaceuticals to patients' health.

Services

1. process impurity identification, process optimization related testing
2. Provide impurity validation and analysis services according to ICH requirements.

Service Targets

1. pharmaceutical manufacturers
2. pharmaceutical R&D organizations
3. third party testing organizations

Our Advantages

1. Professional Technical Team
We have experienced analytical scientists and professional technicians who are capable of handling complex samples and testing needs. Example:
- Surfactants and defoamers: Dimethicone, Spectra 60, PEG, Trilatone, Poroxam, Tween 20/80
- Buffer systems: Arginine, Glycine, Histidine, Cysteine, Imidazole, Tris
- Stabilizers: glucose, sucrose, sorbitol, mannitol
- Antibiotics: polymyxin E, gentamicin, kanamycin, streptomycin, vancomycin
- Transfection reagent: polyethyleneimine
- Process enhancers and catalysts: AEBSF, DTT, IPTG, EDTA, GUANIDINE, TCEP, TEMPO, MSX, PEG
- Solvent residue: DMF, DMSO

2. Advanced equipment
We use the latest chromatographic and detection equipment to ensure the accuracy and reproducibility of data.

3. Strict quality control
We follow dual quality management systems (FDA and CNAS) to ensure the reliability of the testing process and results.

4. Customized Service
We provide personalized service solutions according to customers' specific needs.