Pharmaceutical and Biological Analysis Service

Pharmaceutical and Biological Analysis Service

Unlocking Pharma & Bio Excellence: Choose CD BioGlyco for Unrivaled Analysis Expertise!

CD BioGlyco offers a wide range of analysis services tailored specifically for pharmaceutical and biological products. Our goal is to provide accurate and comprehensive analysis to support drug research and development and quality control.

Our pharmaceutical analysis service mainly contains comprehensive analysis and evaluation of pharmaceuticals and related samples. Using various analytical techniques such as high-performance liquid chromatography (HPLC), gas chromatography (GC), nuclear magnetic resonance (NMR) spectroscopy, and mass spectrometry (MS), we test and validate the purity, stability, and content of drug substances. We help clients to confirm sample compliance with their requirements.

Through a combination of in vitro and in vivo testing methods, we assess the biological activity, pharmacological effects, and toxicity of various biological products. This service aids clients in ensuring the quality, safety, and efficacy of each production stage of bioproduct manufacturing.

We possess years of experience in analyzing and characterizing pharmaceutical excipients, which are essential inactive substances used in drug formulations. Our comprehensive tests evaluate the chemical properties, functionality, and compatibility of excipients with active ingredients, ensuring their suitability and quality for use in pharmaceutical products.

Pharmaceutical and Biological Comprehensive Analysis Service at CD BioGlyco

  • Physical analysis

Physical analyses are conducted rigorously to evaluate the conformity of the pharmaceutical and biological products. This includes assessing its color, appearance, dissolution properties, and any other physical characteristics. By monitoring these properties, we can determine if the product undergoes any changes during storage or handling, and ensure its consistent quality.

  • Chemical analysis

We conduct in-depth chemical analysis to assess the stability and integrity of this pharmaceutical and biological product. We examine the chemical composition, identify and quantify impurities, and investigate any potential photochemical reactions that may occur. We aim to help clients to ensure that the product retains its chemical integrity and potency.

  • We utilize advanced techniques to identify and characterize the chemical structure of pharmaceutical compounds and their impurities. This includes methods such as spectroscopy, MS, and X-ray crystallography.
  • We quantify the concentration of principal components, metabolites, and impurities in pharmaceutical formulations using validated methods. This includes assay development, calibration curve generation, and sample analysis.

  • Microbiological analysis

Our microbiological analysis ensures that sterilized products remain free from microbial contamination. We conduct tests to detect the presence of microorganisms and verify the sterility of the product. Additionally, we assess its pyrogenicity to ensure its safety.

  • Therapeutic efficacy analysis

We have a diverse range of animal models at our disposal to evaluate their therapeutic efficacy. These models encompass various animal species, from mice and rats to pigs and beyond. By conducting experiments on these animal models, we gain a comprehensive understanding of the effectiveness of different pharmaceutical and biological products and determine if the effects are consistent across different animal populations. These animal models play a crucial role in disease research and drug development, aiding clients in better assessing and validating new therapeutic methods.

  • Toxicological analysis

Our team conducts a toxicological analysis to identify any potential adverse effects or toxicity associated with the drug. We determine the level of toxicity through appropriate preclinical testing and compare it to predetermined thresholds. By monitoring and assessing toxicity, we ensure the safety of the drug for its intended use.

  • Stability test

We conduct stability testing to evaluate the degradation patterns and shelf-life of pharmaceutical and biological products under various conditions (temperature, humidity, light exposure). Stability-indicating methods are employed to monitor the degradation of drugs and impurities over time.

Fig.1 Pharmaceutical and biological comprehensive analysis service at CD BioGlyco. (CD BioGlyco)Fig.1 Pharmaceutical and biological comprehensive analysis service at CD BioGlyco. (CD BioGlyco)

Publication Data

Technology: Vibrational spectroscopy, Supercritical fluid chromatography, Multi-dimensional chromatography

Journal: International Journal of Biological Macromolecules

IF: 3.4

Published: 2022

Results: This study provides an overview of the recent developments in analytical techniques used for quality control (QC) in the pharmaceutical industry. The authors mainly introduced technologies that aim to reduce analysis time and cost, improve performance, and minimize the ecological footprint. In this study, they specifically discussed three emerging techniques: vibrational spectroscopy, supercritical fluid chromatography, and multi-dimensional chromatography. The authors use a SWOT analysis to objectively evaluate these techniques. They discussed the requirements and applications of these emerging techniques in pharmaceutical QC. The authors emphasized the numerous possibilities these techniques offer in addressing challenges regarding method efficiency, speed, environmental impact, and sensitivity.

Applications

  • Our analysis services can be used to assess the pharmacological and physicochemical properties of new drug candidates.
  • Our analysis services for drug component testing, purity analysis, impurity detection, and more, can be used to ensure that drugs meet the required requirements for quality and safety.
  • Our analysis services can be used to evaluate the metabolism and interaction of drugs in the body to ensure their safe use.

Advantages

  • We work closely with our clients to develop and optimize analytical methods specific to their pharmaceutical or biological products.
  • The analytical methods we develop are reliable, robust, and in line with regulatory requirements.
  • Our research team consists of highly skilled scientists with extensive experience in pharmaceutical and biological analysis.
  • We provide accurate and reliable results by using various techniques such as HPLC, GC, MS, NMR, and more.

At CD BioGlyco, we are committed to helping our clients advance their research and development efforts. We utilize state-of-the-art analytical techniques and advanced methods to deliver precise and reliable results. Through our expertise, we support the advancement of pharmaceutical and biological research and development, ensuring the safety, efficacy, and quality of pharmaceutical and biological products. Feel free to contact us if you have any questions or would like to learn more about our services.

Reference

  1. Dispas, A.; et al. Emerging analytical techniques for pharmaceutical quality control: where are we in 2022? Journal of Pharmaceutical and Biomedical Analysis. 2022, 115071.
This service is for Research Use Only, not intended for any clinical use.

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About Us

CD BioGlyco is a world-class biotechnology company with offices in many countries. Our products and services provide a viable option to what is otherwise available.

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