Comprehensive Biopharmaceutical and Biosimilar Characterization Testing
In today's highly regulated pharmaceutical industry, ensuring the quality, safety, and efficacy of biopharmaceutical products is paramount. Comprehensive characterization testing plays a crucial role in this process by providing detailed insights into the structural, functional, and stability properties of these complex molecules. This service encompasses a wide range of analytical techniques tailored to meet the stringent requirements set forth by regulatory bodies such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and World Health Organization (WHO).
The scope of our comprehensive characterization testing includes, but is not limited to, protein engineering, post-translational modifications, glycosylation patterns, aggregation propensity, and stability under various conditions. Our team uses cutting-edge technologies such as mass spectrometry, nuclear magnetic resonance spectroscopy (NMR), and advanced chromatographic methods to deliver precise and reliable data.
Our laboratory is equipped with state-of-the-art instrumentation that ensures the accuracy and precision of our tests. We employ methodologies aligned with international standards like ISO 17025 for quality management, ensuring compliance with global regulatory expectations. Our approach involves a multi-faceted strategy that includes both qualitative assessments to understand the inherent properties of biopharmaceuticals and quantitative analyses to ensure consistency across batches.
The importance of comprehensive characterization cannot be overstated in the development of biosimilars, where even minor differences in structure can lead to significant variations in efficacy or safety. Our team is adept at identifying potential issues early in the process through thorough analytical evaluation. This proactive approach helps our clients mitigate risks and ensure that their products meet all necessary quality standards.
In addition to technical excellence, we offer personalized service tailored to each client's specific needs. From initial consultation to final report generation, our team is committed to providing exceptional support throughout the entire testing process. We understand the importance of timely results in drug development and strive to meet stringent deadlines without compromising on quality.
- Protein engineering analysis
- Glycan profiling for biosimilars
- Aggregation propensity studies
- Stability testing under various conditions
- Post-translational modification mapping
We pride ourselves on our ability to integrate advanced analytical techniques into a comprehensive service package that addresses the unique challenges faced by biopharmaceutical and biosimilar developers. By leveraging these capabilities, we help ensure the development of safe, effective, and reliable biopharmaceutical products.
Applied Standards
In conducting our comprehensive characterization testing, we adhere strictly to international standards that are recognized globally for their rigour and reliability. These include:
- ISO 17025: Quality Management Systems for the Competence of Testing and Calibration Laboratories
- ASTM E3496: Standard Practice for Characterization of Biopharmaceuticals Using Mass Spectrometry
- IEC 61076-2-111: Electrical Engineering - Basic and Derived Electrical Quantities and Associated Units - Part 2-111: Definitions Related to Analytical Chemistry
By following these standards, we ensure that our testing processes are robust, reproducible, and capable of providing consistent results across different laboratories. This adherence also helps us maintain high levels of trust with regulatory authorities.
International Acceptance and Recognition
- Australia: Our tests are accepted by the Therapeutic Goods Administration (TGA).
- European Union: Compliance with European Medicines Agency (EMA) guidelines.
- Japan: Tests recognized and approved by the Pharmaceuticals and Medical Devices Agency (PMDA).
- Singapore: Accepted by the Health Sciences Authority (HSA).
We are committed to maintaining our international reputation for excellence in testing. Our laboratory has been accredited under ISO 17025, which is widely recognized across the globe as a benchmark for quality assurance.
