Method Development, Validation & Transfer for Antiviral Drug
For antiviral drugs, comprehensive analytical method development, validation and transfer enable an integrated and effective development path. Nowadays, many pharmaceutical companies prefer to conduct method development and in-process testing under the guidance of industry experts.
Combined with the expertise and skills of our analytical team, BOC Sciences offers a complete analytical development portfolio with the ability to perform comprehensive and integrated analysis of antiviral drugs/API. Equipped with an extensive laboratory infrastructure, we offer a complete analytical package from preclinical studies to regulatory submissions.
- Analytical Method Development
We have considerable experience in the development of analytical methods for both APIs and products for antiviral drugs, which are applicable to our entire analytical portfolio, and for entire life cycle of the drug.
Our analytical method development services for antiviral drug include:
- Quality control of APIs, raw materials, intermediates and final products
- Stability testing
- Substance characterization
- Cleaning validation
- Packaging material testing, extractables and leachables
- Safety, health and environment
- Occupational Hygiene Analysis
- Genotoxic impurities
- Analytical Method Validation
Our experts follow the ICH guidelines for the full validation of our analytical methods and, upon request, specific such as ANVISA or Kojima design. We can design validation protocols adapted to the drug development phase based on your validation requirements.
Our analytical method validation services for antiviral drug include:
- Align with your quality requirements
- Preparation of validation protocols and reports
- Cost-effective solutions
- Analytical method transfer
- Transfer of analytical methods for APIs and products of antiviral drugs to our customers
- Our analytical team assists with your method transfer requirements, such as staff training at your site
Figure 1. Analytical method lifecycle. (Weijun, L. 2019)
Our Advantages
BOC Sciences has extensive experience in the development of analytical methods throughout the lifecycle of antiviral drugs. Initial testing is performed and formally validated in accordance with ICH guidelines, including preparation of validation protocols and reports. Aiming to provide the most cost effective solution, we adapt the validation protocol based on your quality requirements and stage of development.
- Our cGMP analytical team provides comprehensive and efficient project support, and our analytical scientists maintain close communication with our clients to provide efficient analytical services to formulation and manufacturing departments
- Our experienced analytical team is well equipped with state-of-the-art instrumentation to ensure quality service at all stages of antiviral drug research
- We value continuity in analytical work, and our teams continuously train and transfer the analytical methods to quality control departments. Our strength is the development of robust and easily transferable methods
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
- Weijun, L. Points to Consider in Quality Control Method Validation and Transfer. BioProcess International. 2019.
※ Please kindly note that our services are for research use only.
