Ultra-sensitive GLP/GCP Bioanalytics for Drug Development

The company Chimera Biotec provides ultra sensitive GLP/GCP bioanalytics for the drug discovery process. Chimera has Scientist so we asked a few questions to Beena Punnamoottil, Senior Project Manager in the German company to better know its know-how and its vision.

Dr. Punnamoottil, can you tell us more about Chimera Biotec?

Chimera Biotec is a GLP/GCP certified bioanalytical CRO specialized in ultrasensitive large-molecule bioanalysis.

Since 2000, we have built a reputation in supporting drug development programs with the greatest demands on sensitivity and bioanalytical quality. We have the longest standing track record in beyond ELISA sensitivities in the ligand-binding assay CRO market.

What services does your lab offer?

Chimera is a GLP service lab, which offers PK/PD, immunogenicity and biomarker services on classical immunoassay platforms like ELISA and MSD as well as on complementary ultrasensitive immunoassay platforms like Simoa/Quanterix and Immuno-PCR/Imperacer.

With the start of a new bioanalytical project, Chimera Biotec starts with immunoassay technology evaluation services together with either client proprietary or commercially available reagent material.

Once the core assay reagents and technology platform are in place, the assay is developed in agreement with bioanalytical guidance documents.

Thereupon the developed assay is converted into a bioanalytical method, ready for method validation.

Method validations are performed in accordance with the general guideline documents, whether the client is looking for non-regulated discovery phase support, GCP clinical phase support or IND-enabling TOX under full GLP-regime.

We provide ultra-sensitive sample testing and offer sample logistics and data reconciliation services supporting multi-center clinical trials.

What sets your expertise apart from others?

Our main advantage: We know beyond ELISA large-molecule sample testing support better than any other CRO. Not only from the scientific standpoint but also the regulatory requirements.

Building upon our proprietary ultra sensitive Immuno-PCR technology, Imperacer®, our scientific team has gained vast experience in the development and validation of ligand-binding immunoassays. The variety of our platforms allows us to provide complete service packages, with each analyte measured on the optimal platform with the optimal cost-benefit ratio.

We are focused on pharmaceutical and biotech clients who are in need of a reliable partner to hand over bioanalytical projects from immunoassay development to final bioanalytical data transfer. Our clients expect and appreciate our long-standing know and our goal to make most out of any immunoassay platform.

What challenges are you willing to address in the near future?

In the ever-changing landscape of bioanalytic tools and platforms, we will keep up with the development and scientific changes.

Just like in the past, we wish to be not only the contact person but also the partner of each client. We listen to our clients, especially in our area of expertise, understanding the bioanalytical needs of the study is key to delivering the optimal assay support.

Here our clients appreciate and benefit from our strong scientific background. Chimera does not perform lab work according to a book but offers off side analytics if beneficial for the client.

The client can run his development assays on the preferred platform in-house and rely on us when he wishes to outsource specialized services and routine work where needed.

If you are interested in knowing more about Chimera Biotec, visit its profile.