Biopharmaceutical Purity Analysis Service

Biopharmaceutical purity is defined as the ratio of the content of target active ingredients to other impurities in biopharmaceutical products. The primary factors influencing biopharmaceutical purity include: (1) Host Cell Proteins (HCP): protein impurities originating from the host cells during the production process. (2) Residual DNA: genetic material remnants from host cells. (3) Process-related Impurities: impurities introduced during production, including components of culture media, cleaning agents, and antibiotics. (4) Product-related Impurities: including degradation products, aggregates, and isomers. These impurities can provoke immune responses, decrease drug efficacy, harbor pathogenic genes, or activate the host immune system, potentially affecting drug stability, effectiveness, consistency, and safety. Consequently, biopharmaceutical purity analysis is critical to ensure therapeutic effectiveness and minimize potential side effects and immune reaction risks.

 

MtoZ Biolabs utilizes high-performance liquid chromatography (HPLC) for purity assessment of proteins, peptides, and small molecule drugs; Capillary electrophoresis (CE) for separation and analysis of proteins, peptides, and their fragments; Mass spectrometry (MS) for detailed and high-resolution purity evaluations; Electrophoresis (SDS-PAGE) and ultraviolet-visible spectrophotometry (UV-Vis) for protein separation and quantitative purity assessments. We offer comprehensive solutions tailored to your research needs. Our technical specialists are available for a free project consultation.

 



 

Service Advantages

1. Precision Analysis: Our advanced instruments and methodologies can ensure result accuracy and reliability.

2. Versatile Testing Capabilities: We offer a range of analytical methods to accommodate various sample types.

3. Experienced Professionals: Our team of skilled scientists ensures high-quality service execution and data analysis.

4. Efficient Turnaround: We guarantee quick sample processing and data feedback to expedite project timelines.

 

Applications

1. New Drug Development: Ensuring candidate drug purity and safety.

2. Production Quality Control: Monitoring purity during manufacturing to maintain batch consistency and quality.

3. Regulatory Compliance: Supporting drug approvals with essential purity data, adhering to regulatory standards.

4. Efficacy Evaluation: Assessing drug effectiveness and safety via purity analysis.

 

MtoZ Biolabs is dedicated to providing top-tier biopharmaceutical purity analysis services, ensuring product safety and efficacy, and advancing biomedical research and application. We invite you to a complimentary project evaluation to discover more about our services.

 

Deliverables

1. Experimental Procedures

2. Relevant Mass Spectrometry Parameters

3. Detailed Information on Biopharmaceutical Purity Analysis

4. Mass Spectrometry Images

5. Raw Data