Pharmacokinetic / Anti-Drug Antibody ELISA
Krishgen Biosystems, established 2003, is a leading manufacturer of ELISA kits, empowering researchers and clinicians with innovative solutions for biotherapeutic development and discovery.
At Krishgen, we prioritize quality and adhere to stringent quality control measures throughout our manufacturing processes. Our ELISA kits undergo rigorous testing and validation to ensure:
• High Sensitivity: Accurate detection of even low levels of biosimilars and antibodies.
• Specificity: Minimal cross-reactivity with other proteins for precise measurements.
• Reproducibility: Consistent results across multiple assays and batches.
• User-Friendliness: Easy-to-follow protocols and clear instructions for efficient use.
Our comprehensive range of ELISA kits for mAb-based biosimilars offers unparalleled precision, sensitivity, and reliability, enabling optimized therapeutic drug monitoring (TDM) and immunogenicity assessment.
World’s Largest Range of mAb-based Pharmacokinetic ELISA for Biosimilar and Drug Estimation from Krishgen
Krishgen’s KRIBIOLISA TDM ELISA kits cater to a diverse range of mAb-based biosimilars used in various therapeutic areas, including:
- Oncology
- Immunology
- Rheumatology
- Ophthalmology
- Neurology etc
Quantitative Anti-Drug Antibody Testing with Krishgen ELISA
Immunogenicity testing plays a critical role in the development and clinical use of biologics. By measuring the immune response generated by a biologic, researchers can identify potential adverse events and ensure the safety and efficacy of these therapeutic agents. Krishgen Biosystems offers a comprehensive range of immunogenicity ELISA kits specifically designed to evaluate the formation of anti-drug antibodies (ADAs) in patients receiving mAb-based biosimilars.
Why is Immunogenicity Testing Important?
- Identify Adverse Events: Early detection of ADAs can help prevent adverse clinical reactions and ensure patient safety.
- Optimize Biotherapeutic Development: Assess the immunogenic potential of biologics during pre-clinical and clinical development.
- Minimize Treatment Risks: Stratify patients based on their risk of developing ADAs to optimize treatment strategies.
Take a virtual tour of our ISO 13485 certified manufacturing facility!
Key Features of Our Manufacturing Facility:
- ISO Class 7 / 8 Cleanrooms: Our manufacturing areas are maintained in pristine conditions to prevent bio-contamination and ensure product purity.
- Advanced Air Handling Units: Our air handling units provide a controlled environment throughout our manufacturing spaces, minimizing the risk of contamination.
- Automated Production Lines: For efficient and consistent production of ELISA coatings and other products.
- Semi-Automated Processes: Streamlined workflows for washing, blocking, and other critical steps, reducing the risk of human error.
Our Commitment to Quality:
- Rigorous Quality Control: Every product undergoes stringent quality checks at various stages of production to ensure it meets the highest standards.
- Traceability: We maintain detailed records of all products, allowing for complete traceability and accountability.
- Continuous Improvement: We are dedicated to ongoing improvement and invest in the latest technology and techniques to enhance our manufacturing processes.
Precision and Reliability
Cost Efficiency
Comprehensive Range
Robustness
If you cannot find what you are looking for, our application support team can find it for you! Get in touch today.