Your study needs define our assays

We tailor your customized assay to your study or use already available kits.

As your single point of contact, your dedicated project manager at Chimera ensures that your scientific input guides our assay development towards the optimal assay procedure on the ideal platform.

Tailored immunoassay solutions for biologics, biosimilars, and biomarkers – ensuring regulatory compliance and technological excellence

In today’s biopharmaceutical research and development, companies face numerous challenges in assay development. Developing precise and sensitive immunoassays is crucial for the success of biologics, biosimilars, and biomarkers. However, the complexity of these processes can often be overwhelming. This is where chimera biotec steps in to address these challenges and offer tailored solutions.

Challenges in Assay Development

1. High Sensitivity and Specificity: One of the biggest challenges is developing assays that are both highly sensitive and specific. This is particularly important for detecting low concentrations of analytes in complex biological matrices.
2. Regulatory Requirements: Meeting stringent regulatory requirements such as GLP, GCP, and non-GxP, as well as compliance with FDA and EMA guidelines, presents another hurdle. These requirements must be met to ensure the approval and market launch of new therapeutics.
3. Technological Diversity: Choosing the right platform and technology for a project’s specific needs can be difficult. Different projects require different approaches, and selecting the optimal method is crucial for success.
4. Time and Cost Management: Efficient time and cost management is essential to complete projects within budget and on schedule. Delays or unexpected costs can jeopardize the entire development process.

Solutions from chimera biotec

Chimera biotec specializes in developing highly sensitive immunoassays and offers tailored solutions to overcome these challenges.

1. Top-Notch Sensitivity and Specificity: With over 20 years of experience in immunoassay development, Chimera biotec provides assays that ensure the highest sensitivity and specificity. Our advanced technologies enable the detection of even the lowest analyte concentrations, which is crucial for the accuracy and reliability of results.
2. Regulatory Expertise: Our GLP-certified laboratory offers services that meet the highest regulatory standards. We work closely with our clients to ensure that all assays comply with GLP, GCP, and non-GxP requirements, as well as FDA and EMA guidelines.
3. Technological Flexibility: Chimera biotec utilizes a variety of platforms and technologies to meet the specific needs of each project. Our expertise in different assay formats allows us to find the optimal solution for any challenge.
4. Efficient Project Management: Through our efficient project management, we ensure that projects are completed on time and within budget. Our extensive experience and commitment to quality and efficiency help our clients achieve their goals.

With chimera biotec as a partner, companies can be confident that their assay development challenges will be professionally and efficiently addressed. Our tailored solutions and commitment to the highest quality make us the ideal partner for biopharmaceutical projects.