Antiviral Drug Analysis Services
Pharmaceutical analysis plays an important role in the new drug development process and GM P manufacturing. be addressed by a better understanding of the drug substance, drug product or manufacturing process that can provide pharmaceutical companies with important information about drug safety, manufacturing process complexity and regulatory requirements. Analytical testing of pharmaceutical drugs involves chemical, physical, and sometimes microbiological analysis. The process involves identifying novel drugs, assessing their affinity and specificity, characterizing their molecular structure, and testing their efficiency in vitro and in vivo.
Equipped with cGMP-compliant laboratories and state-of-the-art analytical instrumentation, BOC Sciences has successfully handled many complex antiviral drug analysis projects for our clients. We are committed to providing smarter strategies for drug analysis to address issues that can arise in antiviral drug development.
Figure 1. Targets of antiviral drug therapy. (Babar, M.; et al. 2013)
Comprehensive Services
- BOC Sciences has a proven track record of providing a variety of analytical testings for regulatory-compliant drugs. Our team is able to provide specialized antiviral drug analysis services to support research & development programs (R&D), regulatory submissions, GM P manufacturing and post-marketing requirements
- With our specialized drug analysis capabilities for small molecule drug products, we can help you accelerate your development process, obtain the right data to complete marketing authorization applications, and support your post-marketing requirements
BOC Sciences has extensive experience in the development of analytical methods throughout the lifecycle of antiviral drugs. All testings we perform are conducted and formally validated in accordance with ICH guidelines. We adapt our validation protocols according to our clients' quality requirements to provide the most cost-effective solutions. Effective method development ensures that laboratory resources are optimized while the method meets the target requirements for each stage of drug development. In general, we test the analytical method extensively for: specificity, linearity, accuracy, precision, range, detection limits, quantitation limits, and robustness. In addition, our method validation process is used to demonstrate the suitability of an analytical procedure for its intended use.
Our team typically validates test methods for:
- APIs
- Drug product
- Drug product containers
Method transfer is another key element of any pharmaceutical development program. At BOC Sciences, method transfer is the process of evaluating the applicability of our developed methods in another laboratory.
Comprehensive characterization of physical and chemical properties, stability analysis, and purity testing of APIs for antiviral drugs are regulatory requirements and important steps in drug development. Only a comprehensive and thorough understanding of API properties allows for product quality control throughout the process. Our state-of-the-art instrumentation combined with the expertise of our experienced scientists provides a thorough understanding of antiviral API.
Understanding and controlling the level of impurities in antiviral drug is required to safely deliver drugs to patients. Impurities not only affect the safety of a drug, but can also impact development time if they are not addressed early in the drug scale-up manufacturing process. BOC Sciences has introduced sophisticated chromatographic, spectroscopic and coupling techniques to establish a general scheme for estimating impurities in multiple antiviral drugs.
Figure 2. Some plant-derived products possessing inhibitory effects on various viruses. (Babar, M.; et al. 2013)
BOC Sciences is able to offer a wide range of structural analysis methods to identify the structure of the finished product of your antiviral drug. In consultation with our clients, our experts apply the latest chromatographic and spectroscopic techniques to establish the most efficient strategies for structure elucidation and evaluation. Our analytical laboratory can support the full characterization of a wide range of antiviral drug products to meet the regulatory requirements of your registration dossier. Our analyses range from physicochemical parameter evaluation and pre-processing to building complete analytical test programs.
Stability study of antiviral drugs is a matter of great interest to study their safety and efficacy throughout their shelf life, and it has become a prerequisite for the acceptance and approval of antiviral drug products. At BOC Sciences, our stability storage infrastructure is capable of providing comprehensive stability testings for various antiviral drugs at all stages of development
We offer the following services to our clients:
- R&D preliminary studies
- Quality control stability studies and release testing
- Comparator studies
- Photostability studies
Analytical Techniques
Quality control and assurance of the analytical process is of vital importance. Our analytical scientists are capable of selecting the most appropriate analytical technique for you.
- High Performance Liquid Chromatography (HPLC)
- Ultra Performance Liquid Chromatography (UPLC)
- Gas Chromatography (GC)
- Gas Chromatography-Mass Spectrometry (GC-MS)
- Liquid Chromatography/Mass Spectrometry (LC/MS)
- Atomic Absorption Spectrometry (AAS)
- UV/Visible spectrometry
- Fourier transform infrared (FTIR) spectrometry
- Capillary electrophoresis (CE)
- Karl Fischer titration
- Inductively coupled plasma (ICP-OES, ICP-MS)
- Nuclear Magnetic Resonance (NMR)
- Differential Scanning Calorimetry
- Thermogravimetric analysis
Figure 3. Chemical structures of some potent antiviral agents of natural origin. (Babar, M.; et al. 2013)
Why Partner with BOC Sciences?
- We apply our years of proven expertise and experience in antiviral drug development to improve the success of your program
- Our continuously updated facilities support a range of antiviral drug analysis and manufacturing services
- BOC Sciences' experienced team of scientists and regulatory staffs are focused on working with our clients to deliver timely and high-quality small molecule antiviral drugs
- Our partnerships with leading experts in emerging technologies allow us to apply innovative solutions to your antiviral drug research programs
Reference
- Babar, M.; et al. Hydrated polymer system as efficient carrier for the delivery of drugs against viral infections. Journal of Antivirals and Antiretrovirals. 2013. 5(2): 028-036.
※ Please kindly note that our services are for research use only.
