Biological Evaluation Service

Deciphering Glycobiology's Language: Illuminate Your Path to Discovery with CD BioGlyco's Biological Evaluation

With our specialized expertise in the field of Pharmaceutical and Biological Analysis, CD BioGlyco offers a comprehensive evaluation service for carbohydrate-related biological products. Biological products, also known as biologicals, are a category of medicines that are produced by growing and purifying them from large-scale cell cultures of bacteria, yeast, plant, or animal cells. These medicines are derived from living organisms and are generally purified from living culture systems or blood. The biologicals we analyze either have carbohydrate as the key component or carbohydrate as an ingredient. Those diverse biologicals bring unique benefits and are often utilized in the research of various diseases. Our scope of evaluation encompasses a wide range of biological products, including:

• Vaccine

Our vaccine analysis entails determining the total solids, protein content, nucleic acid content, and polysaccharide content in the vaccine. In sterility testing, we conduct rigorous examinations to ensure that the vaccines are free from any viable microorganisms. Pyrogen testing is performed to detect the presence of fever-inducing substances in vaccines, ensuring their safety and efficacy. We also will conduct bacterial endotoxin testing to identify and quantify any bacterial endotoxins in the vaccines. Our vaccine analysis service encompasses raw materials testing, semi-finished product testing, and finished product testing.

• Raw materials testing: This involves analyzing the quality and purity of the ingredients used in the production of vaccines. It includes testing the raw materials for contaminants, evaluating their potency, and verifying the presence and concentration of essential components.
• Semi-finished product testing: This stage involves conducting comprehensive tests on vaccines at intermediate stages of production. It includes assessing critical parameters such as potency, stability, and purity to ensure that the semi-finished vaccine meets the required requirements.
• Finished product testing: This final stage involves rigorous evaluation of the fully formulated vaccine. It includes verifying the vaccine's potency, stability, safety, and efficacy. Additionally, tests are conducted to ensure compliance with the client's requirements and to detect any potential contaminants.

Our evaluation service for vaccines includes but is not limited to:

Typhoid Vaccine Evaluation Service

Group A Meningococcal Polysaccharide Vaccine Evaluation Service

23-Valent Pneumococcal Polysaccharide Vaccine Evaluation Service

Haemophilus influenzae Type b Conjugate Vaccine Evaluation Service

Poliomyelitis Vaccine in Dragee Candy Evaluation Service

Through our comprehensive vaccine analysis service, we strive to help clients ensure the quality and integrity of vaccines, adhering to related requirements.

• Immunoglobulin

We provide advanced immunoglobulin analysis services that cover a comprehensive range of parameters, ensuring the highest quality and accuracy in our analysis.

• First, we offer precise measurements of protein content and carbohydrate content, allowing for accurate determination of the quantity of immunoglobulin present in the sample. Purity analysis is another essential aspect we focus on.
• Our rigorous analysis techniques can identify impurities or contaminants, ensuring the integrity and safety of the immunoglobulin sample.
• The pH value determination is crucial as it helps evaluate the stability and suitability of the product. Our experts employ state-of-the-art methods for pH analysis, providing reliable results.
• We perform heat stability tests, exposing the immunoglobulin sample to varying temperatures to determine its resistance to thermal degradation.
• Residual ethanol content assessment is an integral part of our testing. We meticulously perform analysis to detect even trace amounts of ethanol, minimizing the potential risks associated with its presence.
• We conduct a thorough heat origin examination to ensure the absence of any heat-induced or thermal damage to the immunoglobulin sample. This helps guarantee the product's effectiveness and safety.
• Molecular size distribution analysis allows for understanding the heterogeneity of the immunoglobulin sample, aiding in the characterization and comparability studies.
• To assess its physical properties, we conduct thorough physical examinations, evaluating color, odor, and visual appearance.

Fig.1 Our immunoglobulin analysis. (CD BioGlyco)

With our comprehensive immunoglobulin analysis services, we strive to provide accurate and reliable data to support research and development efforts, helping clients ensure the safety and effectiveness of immunoglobulin-based therapies. Our evaluation services for immunoglobulins include, but are not limited to:

• Other products

We not only assist clients in analyzing the mentioned biological products but also provide analysis for other types of products.

Publication Data

Applications

• Our evaluation helps assess the safety and efficacy of biological products used in medical research, including immunotherapies, gene therapies, and regenerative medicine.
• Our evaluation supports the development of new biological products by providing data and insights for preclinical and clinical studies.
• Our evaluation helps maintain the consistency, purity, and quality of biological products during their manufacturing process.
• Our evaluation assists in the evaluation and optimization of bioprocesses for the production of biological products, ensuring their quality and yield.

Advantages

• We offer a wide range of evaluation services for carbohydrate-related biological products and our evaluation covers various aspects. This comprehensive approach ensures the thorough and accurate assessment of the quality, safety, and efficacy of the products.
• We have state-of-the-art technologies that enable us to perform a variety of tests on biological products. Our testing capabilities encompass raw materials testing, semi-finished product testing, and finished product testing. This allows us to assess the quality and purity of the ingredients, and evaluate critical parameters at different stages of production.
• We understand that each client and product is unique, and we tailor our evaluation services to meet specific requirements.
• Whether it's a novel carbohydrate-based vaccine or a well-established biologic, we work closely with our clients to develop customized testing protocols and provide personalized support throughout the evaluation process.

At CD BioGlyco, our primary goal is to contribute to the advancement of glycoscience by ensuring its quality, safety, and efficacy. With our evaluation service, clients can have confidence in their products and expedite the regulatory approval process. Our service is designed to assist clients in ensuring the quality, safety, and efficacy of their biological products. We understand the unique nature of biologicals and recognize the importance of rigorous testing at each stage of production. Our team of experts follows international guidelines and standards to ensure consistency and comparability of the products. Don't hesitate to contact us for further discussion on our services.