Zelle Research & Analytical Services
-A GLP Cerified Facility
Zelle Research & Analytical Services (ZRAS) has been serving the Biopharma Industry by offering innovative scientific solutions for over a decade. Our state-of-the-art facility is GLP Certified and ensures the highest standards of precision and quality in everything we do. Our reports are widely recognized for their steadfast adherence to stringent standards and have been submitted to regulatory authorities around the globe. Every piece of data we generate is rigorously analyzed and diligently assembled, reflecting our unwavering commitment to accuracy and reliability. Backed by a team of experienced scientists, we bring in a wealth of knowledge and expertise to every project, making your success our top priority.
- State-of-the-art GLP Certified Facility
- Scientific Excellence
- 21 CFR Compliant
- Validated Methods
- Development Driven
- Tailored Solutions
- Excellence in Project Management
Analytical & Research Capabilities
Our expertise in biosimilar analysis and impurity assessment enables us to customize solutions that align perfectly with your unique requirements. A manufacturer with an in-depth understanding of its product and production processes stands the greatest chance of reducing potential risks during the product development phase. Although the approval of any product depends on the entirety of data within the submission, a strong demonstration of overall product knowledge can expedite regulatory review. Our comprehensive testing approach provides a holistic understanding of your product and ensures that your product meets the safety and efficacy standards, all while adhering to stringent ICH guidelines. As the biopharmaceutical industry evolves, so do we, with a dedication to expanding our service offerings and driving innovation that propels your projects forward.
At Zelle Research & Analytical Services, we are your partner in progress, where precision, innovation, and excellence redefine industry standards, unlocking new possibilities for your research and development endeavours.
PROTEIN QUANTIFICATION
Protein Quantification being a key part of ICH Q6B, is essential in understanding the protein content of the sample or formulated product. It helps in demonstrating consistency and comparability between different batches. At ZRAS, we perform
PROTEIN PRIMARY STRUCTURE
With a superior understanding of Mass Spectrometry and regulatory requirements, the scientists from our team provide a comprehensive report covering all aspects of the molecule’s primary structure and help by interpreting the data with great certainty.
PROTEIN MODIFICATION
With a superior understanding of Mass Spectrometry and regulatory requirements, the scientists from our team provide a comprehensive report covering all aspects of the molecule’s primary structure and help by interpreting the data with great certainty. We perform
GLYCOSYLATION PROFILING
Protein glycosylation is a post-translational modification which plays an important role in altering the pharmacokinetics by stabilizing the protein conformation, improving solubility or protecting from proteases. Characterizing Glycosylation is a key requirement of the ICH Q6B guidelines. At ZRAS, we perform
HIGHER ORDER STRUCTURE
Incorrect higher-order structure leading to aggregation and exposure of immunogenic epitopes can raise major safety concerns and hence, it is essential to analyze a molecule’s Higher Order Structure. At ZRAS, we perform
AGGREGATE ANALYSIS
Aggregation of proteins is a challenge commonly faced during the manufacturing of biopharmaceuticals. Tracking aggregation throughout the product’s lifecycle is a necessary regulatory requirement.
Our most recent addition, Wyatt’s DAWN 8 for SEC-MALS Analysis, determines the absolute molar masses of proteins, biopolymers and synthetic polymers, through multi-angle light scattering (MALS).
The combination of UV, Refractive Index and MALS detection provides an overall view of the aggregation profile of a molecule.
IMPURITY AND CONTAMINANT ANALYSIS
Every product intended to be used as a therapeutic agent in humans or animals should be highly purified to avoid potential health risks or other problems that might result from trace contaminants. At ZRAS, we identify
POTENCY TESTING
Potency assays are critical for product development and manufacturing as they reflect the product’s mechanism of action. It ensures the quality, safety, and efficacy of biopharmaceutical products, and also provides confirmation of biocomparability between an innovator and biosimilar product