Immunoassay Development, Method Validation and Bioanalysis

We support your study and help you


                    ♦  find the right immunoassay platform for your study
                    ♦  check the feasibility of your idea
                    ♦  develop an assay tailored to your requirements
                    ♦  qualify or validate your assay under the regulations of your choice
                    ♦  perform bioanaylsis including the needed reports
                    ♦  use kit-based bioanalysis
                    ♦  save money and time in the long run and accerlerate filing

 

Biotherapeutic drug candidates may have a very low first-in-human starting dose and drug concentrations can vary significantly within a single patient.
Providing data from early phases of clinical development can help to quickly move forward towards regulatory filing and save money in the long run.

Chimera Biotec provides ultra sensitive GLP/GCP bioanalytical support for all phases of drug development and non-regulated rapid discovery phase research.

 

Assay Development

Method Validation

Bioanalysis


 

Needing help?

Your study is unique! Therefore, you may require certain parameters, handle rare matrices or you are restricted to some options.

              ♦   Sensitivity requirements
              ♦   Regulatory requirements (GLP / GCP)
              ♦   Desired assay range
              ♦   Sample volume

 

Our dedicated PhD level project managers will happily assist you sorting out all the details.

 

Technology Evaluation

 

 


 

Ultra sensitivity

Since the year 2000 we focus on ultra sensitive and technically demanding immunoassays.

Thus, we created our proprietary Immuno-PCR platform Imperacer®.

              ♦   Ultra sensitive (fg/ml)
              ♦   Broad assay range (3-6 lof units)
              ♦   Working with lowest sample volumes (less than 10 µl)
              ♦   Adaptable to regulatory requirements (GLP / GCP)

 

Ultra sensitivity

 


 

Microsampling

Being the leading CRO for ultra sensitive immunoassays, we gained a lot of experience working with low samples volumes and rare matrices.

              ♦   Rare matrices
              ♦   Low concentration
              ♦   Low dosing
              ♦   Dried spot analysis

 

Microsampling

 


 

AnySource® Sample Dilution Technology

We own a whole collection of sample dilution buffers, which we adapt to your assay.

Our ultra sensitive Technologies allow us to use high samle dilution and reduce background noise and matrix effect drastically.

          

 

Microsampling

 


 

GLP/ GCP

At our GLP-certified laboratory, we can work under the regulation of your choice.

              ♦  Non-regulated
              ♦  Good clinical practice (GCP)
              ♦  Good Laboratory Practice (GLP)
              ♦  Compliance to FDA and EMA guidances.

At our GLP-certified laboratory, we provide 24/7 monitored frozen storage and are organized to take part in complex multi-center trials.

          

 

GLP/GCP

 


 

Immunoassay Platforms

We offer ultra sensitive as well as standard platforms.

              ♦  Imperacer®
              ♦  Simoa® (Quanterix)
              ♦  MSD™
              ♦  High sensitive ELISA

All bioanalytical services are performed in our GLP-certified laboratory.

 

Platforms

 


 

Applications

We offer complete service packages for different applications.

              ♦  Biomarker assays
              ♦  PK/KD assays
              ♦  ADA / Immunogenicity assays
              ♦  nAb/ Neutralizing antibody assays

Also check out our literature to find published paper and case studies.

 

Applications

 


 

About Us

Learn more about our company or become part of our team.

              ♦  Philosophy
              ♦  Partners
              ♦  Carrer
              ♦  News and Events
              ♦  Blog News

Also subscribe to our Newsletter and check out our
Blog News with latest papers in your field.

 

About Us

 

Supporting your success in all phases of drug development by providing highly sensitive, accurate
and reliable bioanalytical data on-time.