Services | Assay development Bioanalysis Technology evaluation Method validation

Biologics, biosimilars and biomarkers

 

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Revolutionize Your Research with Chimera

Cutting-Edge solutions in biologics, biosimilars, and biomarkers

Unlock the potential of your research with Chimera’s expertise in biologics, biosimilars, and biomarkers. Our state-of-the-art technologies ensure ultra-sensitive detection and precise analysis, driving innovation in drug development. With GLP/GCP-compliant assays, we guarantee the highest standards of accuracy and reliability. Partner with us to accelerate your path to groundbreaking discoveries and regulatory success. Trust Chimera for unparalleled bioanalytical support tailored to your unique needs. Elevate your research today with our cutting-edge solutions.

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Customized Immunoassay Solutions

Enhance your bioanalytical studies with Chimera’s technology evaluation services. We pinpoint the perfect ultra-sensitive immunoassay platform tailored to your specific needs, ensuring precision and reliability

Regulatory Precision Assured

Achieve the highest standards with Chimera’s method validation services. Our GLP/GCP-compliant assays ensure precision and regulatory compliance for all your bioanalytical needs.

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Unlock the Future of Assay Development with chimera biotec

Tailored solutions and unmatched expertise for your scientific success

Discover the excellence of Chimera in assay development! With over 20 years of experience, we offer tailored solutions for your studies. Our process begins with technology evaluation, selecting the ideal platform based on your pharmacological needs. We then conduct reagent qualification to identify the best candidates through rapid feasibility studies.

A crucial step is detection antibody conjugation, ensuring optimal synthesis for your preferred platform. Our assay setup and optimization includes adapting to various matrices and optimizing sample volumes for the best results. Finally, we guarantee the highest bioanalytical quality through assay performance tests, qualifying and validating your assays.

Our comprehensive services include:

  • Technology Evaluation
  • Reagent Qualification
  • Detection Antibody Conjugation
  • Assay Setup and Optimization
  • Assay Performance

Trust Chimera to successfully realize your projects. Start your project with us and benefit from our expertise and commitment to quality and innovation. Let’s achieve your scientific goals together!

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Assay development

In addition to our core services, Chimera excels in method validation and bioanalysis. Our GLP-certified laboratory ensures compliance with FDA and EMA regulations, providing robust and reliable data for your studies. We specialize in ultra-sensitive immunoassays, leveraging our proprietary Immuno-PCR technology, Imperacer®, to achieve beyond ELISA sensitivities. This allows us to detect biomarkers at sub-pg/ml concentrations, crucial for pharmacokinetics, pharmacodynamics, and immunogenicity testing.

Our AnySource® sample dilution technology enables us to handle diverse and challenging matrices, ensuring accurate and reproducible results. Whether you are working with animal, artificial, or human samples, we adapt our assays to meet your specific needs. Our commitment to innovation and quality makes us the ideal partner for your bioanalytical projects. Contact us today to learn more about how we can support your research and development efforts.

Method Validation

Ultra sensitive, selective, accurate and precise

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Unlock the Full Potential of your Bioanalytical Studies with chimera biotec

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Experience unmatched sensitivity, customization, and regulatory compliance for reliable and efficient drug development

When it comes to bioanalytical services, Chimera stands out as a leader in the field, offering a range of specialized services designed to meet the unique needs of their clients. From ultra-sensitive immunoassays to comprehensive method validation, Chimera provides unparalleled expertise and support throughout the drug development process. Here’s a closer look at the benefits customers can expect when partnering with Chimera.

Optimal Technology Selection

Choosing the right platform technology is crucial for achieving precise and reliable bioanalytical results. Chimera offers expert guidance in selecting the most suitable ultra-sensitive immunoassay platform for specific bioanalytical studies. This ensures that customers benefit from the best technology available, tailored to their unique pharmacological needs. By leveraging Chimera’s extensive knowledge and experience, clients can be confident that their assays will deliver accurate and consistent results.

High-Quality Reagents

The quality of reagents used in bioanalytical assays directly impacts the reliability and consistency of the results. Chimera excels in the careful selection and qualification of both proprietary and commercially available reagents. This meticulous approach ensures that every assay meets the highest standards of quality, providing customers with dependable data that can be trusted for critical decision-making in drug development.

Customized Detection Solutions

One of the standout features of Chimera’s services is their ability to provide tailored detection solutions. By synthesizing or selecting optimal detection conjugates for the preferred immunoassay platform, Chimera enhances the sensitivity and specificity of assays. This customization is particularly advantageous for complex biological samples, ensuring that even the most challenging matrices yield reliable and accurate data.

Efficient Assay Development

Time and resources are precious in the fast-paced world of drug development. Chimera biotec’s comprehensive assay optimization services save both by allowing assays to be quickly and efficiently adapted to various matrices and sample volumes. This streamlined process not only accelerates the development timeline but also ensures that assays are robust and reliable, meeting all necessary bioanalytical guidelines.

Regulatory Compliance

Navigating the regulatory landscape is a critical aspect of bioanalytical testing. chimera biotec’s services are conducted under GLP, GCP, and non-GxP regulations, ensuring full compliance with FDA and EMA guidelines. This regulatory assurance provides customers with peace of mind, knowing that their assays are not only scientifically sound but also meet all necessary legal and regulatory requirements.

Enhanced Sensitivity

Ultra-sensitive assays are essential for obtaining accurate and reliable data, especially in the context of pharmacokinetics, pharmacodynamics, immunogenicity tests, and biomarker applications. Chimera biotec’s expertise in developing and validating these assays ensures that customers receive the highest quality data, crucial for making informed decisions in drug development.

Comprehensive Support

From early discovery to clinical trials, Chimera offers full support throughout the drug development process. This includes method validation, sample management, and regulatory guidance, providing a seamless bioanalytical workflow. Customers benefit from a dedicated scientific team that offers personalized support and advice, ensuring that every project is handled with the utmost care and expertise.

Efficient Sample Handling

Handling low sample volumes and rare matrices can be challenging, but chimera biotec specializes in microsampling and managing these difficult samples. Their expertise ensures that even the most challenging samples yield reliable results, providing customers with the data they need to advance their drug development programs.

Tailored Validation

Chimera biotec’s method validation services are highly customizable, allowing clients to include or exclude specific validation parameters based on their study design. This flexibility ensures that the validation process is precisely adapted to meet the unique requirements of each project, enhancing the reliability and robustness of the results.

Access to Validated Kits

In addition to custom solutions, chimera biotec also utilizes validated commercial assay kits when appropriate. This includes high-sensitive ELISA kits and Quanterix Kits, which can significantly reduce development time while maintaining high standards of reliability and accuracy.

In summary, partnering with chimera biotec offers a multitude of benefits for customers seeking high-quality bioanalytical services. From optimal technology selection and high-quality reagents to comprehensive support and regulatory compliance, chimera biotec provides the expertise and resources needed to achieve precise, reliable, and efficient bioanalytical outcomes. With their tailored solutions and dedicated scientific team, chimera biotec is the ideal partner for advancing your drug development programs.

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Services | Assay development Bioanalysis Technology evaluation Method validation

Discover the future of biotechnology with Chimera Biotec!

Innovative solutions for a better tomorrow.