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"Your ultra sensitive GLP/GCP lab"

 

Premium German service provider

We support
       ♦  non-regulated studies - e.g. discovery phase 
       ♦  GLP-regulated studies - e.g. TOX
       ♦  GCP-regulated studies - e.g. clinical phase I-IV
We work in accordance with regulatory requirements and guidance documents.

 

Assay Development

Method Validation

Bioanalysis

 

Study Needs

We Provide

GLP/GCP FDA and EMA compliance

Sensitivity
 

Detect sub pg/ml in matrix
Low-dosing, low-level biomarkers
Assay range
 
3-6 log units (fg-µg/ml)
One assay from TOX to clinic
Sample volume
 
Immunoassay microsampling
Below 10 µl, saliva, BALF, lysates
and more

 

Overcoming challenges

Working with rare matrices or invasive methods requires microsampling - we can work with sample volumes down to 1 µl.
Discover our AnySource® Dilution Technology. We can make more out of small sample volumes, while keeping ultra sensitive detection by exponential signal amplification via Imperacer®.




"Early Phase PK Data - Accerlerate your drug pipeline"

 

PK data for low-dosing drug candidates

Modern highly potent large-molecule drug candidates require careful safety and efficacy considerations. In immunotherapies, antibody-based T-cell therapies have been associated with TOX profiles and cytokine release syndrome.

This has been well known in immunotherapies, where antibody-based T-cell therapies have been associated with TOX profiles and cytokine release syndrome.

In consequence, dose escalation starts with extremely low dosing, but and may remain close to below the LLOQ in many early bioanalytical clinical study support opposite to high concentrations in preclinical TOX studies.

Therefore, PK supporting sample testing ideally combines
(i) detection of very low target concentrations (single digit fg or pg/mL) with
(ii) broad concentration range (covering TOX and low-dosing) all in one assay.

 

 

We provide meaningful PK data at your needed sensitivity, e.g. when drug leaks from the site of action into the periphery and needs to be quantified from blood samples.

 

Combine excellent sensitivities & broad quantitative assay range

There is no need to validate various immunoassays. Chimera supports your whole biologics PK study in one assay method on Imperacer®.

 

Sample testing with validated methods from a single assay format.

 

Quantifying low-dosed drug concentrations, we provide PK data from early phase of your clinical dose escalation trials under GCP.
Using our AnySource® Dilution Technology to reduce matrix effects, we can make more out of small sample volumes, but keep ultra sensitive detection via Immuno-PCR-based signal generation.

This strategy helps with clinical study design and patient enrolment and accelerates the drug development process to quickly move forward to regulatory filing.




"Vaccination - No Cold Chain, No Needles"

 

Thermostable Vaccines

Maintenance of the cold chain is mandatory to ensure the stability of fragile biological products. Global vaccine distribution is hampered, since not for every region a continuous storage cold chain can be assured.
In addition, needle-free, thermostable vaccines can significantly improve global access and acceptance to vaccination programs.

Being partner in a European research consortium (MACIVIVA), Chimera Biotec has used its proprietary Immuno-PCR platform Imperacer® to support the development of needle-free, thermostable solid vaccines.
Chimera’s immune-analytical expertise resulting from these research and development efforts can be applied to support other vaccination programs as well. For example, to overcome analytical challenges resulting from comparable site-of-action biological test specimen.

In case of indications affecting the lung, such as Covid-19, antibody-, but also biomarkers or drug-levels can be measured from lung samples, such as

      ♦ Sputum,
      ♦ Bronchoalveolar lavage fluid (BALF)
      ♦ Exhaled breath condensate (EBC)
      ♦ and more

Mucosal Vaccination

Viral infection can exploit weaknesses of the immune system or directly attack it. Classic approaches focus on neutralizing antibodies in the bloodstream, However, with viruses like HIV, once the virus has infected immune cells, it is already too late.

Mucosal vaccination approaches aim to block early absorption events of mucosal transmitted viruses and thus inhibit infection by blocking transport of virus particle through mucosal tissue into the lymphatic system. Antibody response blocking the needed receptor interactions leads to protection.

The predominant antibody form in mucosal tissue is IgA, able to block proteins that are needed for transport, however IgG response plays a significant part in mucosa as well. Therefore, vaccination status must be detected in mucosal tissue where antibody concentration is 100 times lower and samples are harder to take in a standardized way.

 

The resulting bioanalytical challenges exceed ELISA possibilities:

         ♦ Mucosal antibody concentration is 100-fold lower compared to blood
         ♦ Mucosal washes hold even lower concentrations
         ♦ Detection from limited sample volume
         ♦ Measuring multiple analytes in parallel
         ♦ Discriminate vaccine- as well as total antibody response from various matrices e.g. mucosal tissue and blood samples
         ♦ Combine excellent sensitivity and broad assay range

 

Chimera mastered these challenges with the development of ultra sensitive Immunoassays, capable of measuring vaccine specific mucosal antibodies and total immune response at the needed sensitivities and concentration ranges from limited sample volumes of mucosal washes.


Our Imperacer® assays allow parallel double determination of multiple analytes from less than 10 µl sample volume - in this case 6 analytes from 8 µl.

 

 

Combining bridging and sandwich assay formats, custom developed for each analytical task on the ultra sensitive Immuno-PCR based Imperacer platform, we supported proof of concept preclinical studies and a clinical trial on HIV-1 mucosal virosome vaccination.

Virosomes are efficient antigen delivery vehicles. Their empty lumen lacks nucleic acid, making them non-infectious.

With the help of Chimera’s state-of-the art immunoassay analytics, virosomes displaying a particular HIV antigen structure, have been shown to increase mucosal antibodies blocking early transmission events. Since respiratory, genital and gastrointestinal mucosa are interconnected, NK cells, T and B lymphocytes can migrate and seed to distant mucosal tissue.


Thus, a more robust genital and intestinal immune response can be elicited by two defense lines:
       ♦ 1st    -   Antigen-specific immune cells provide mucosal protection
       ♦ 2nd  -   Generation of blood antibodies

 


Read more
Aided by Chimera’s Immunoassay monitoring of mucosal as well as blood level antibody response, the study shows a strong vaccine-triggered inhibition in HIV-1 transcytosis by increased vaginal HIV antigen-specific IgG and IgA antibodies. Despite low antibody contents, as compared to serums, vaginal secretions of vaccinated women have been demonstrated to harbor antiviral activity.

Amacker et al. (2020) New GMP manufacturing processes to obtain thermostable HIV-1 gp41 virosomes under solid forms for various mucosal vaccination routes

Leroux-Roel et al. (2013) Randomized Phase I: Safety, Immunogenicity and Mucosal Antiviral Activity in Young Healthy Women Vaccinated with HIV-1 Gp41 P1 Peptide on Virosomes




"The Power of Sample Dilution"

Limited Sample Volume

While microsampling had been a topic mostly discussed in pre-clinical studies with small animals or rare matrices, nowadays many people have experienced microsampling themselves - for example when they had to do a Covid-19 test.

Specimen collected may be

  • Nasopharyngeal or oropharyngeal mucus
  • Nasal wash or aspirate
  • Saliva

Other rare matrices often require even more invasive procedures:

  • Cerebrospinal fluid                       -        Lumbar punction
  • Aqueous humor                            -        Syringe injection
  • Bronchoalveolar lavage fluid      -      Tracheal washes

Overcoming challenges

 

Using our AnySource® Dilution Technology, we can make more out of small sample volumes. Even from volumes down to 1 µl, we can run multiple assays whilst keeping ultra sensitive detection by exponential signal amplification via Imperacer®.

 

 




 

"GLP / GCP Bioanalytical Service"

 

 

 

Biomarker

 

 

 

Premium German service provider

We support
       ♦  non-regulated studies - e.g. discovery phase 
       ♦  GLP-regulated studies - e.g. TOX
       ♦  GCP-regulated studies - e.g. clinical phase I-IV
We work in accordance with regulatory requirements and guidance documents.

 

Pharmacokinetik

Pharmacodynamic

ADA/ Immunogenicity

 

Overcoming challenges

Working with rare matrices or invasive methods requires microsampling - we can work with sample volumes down to 1 µl.
Discover our AnySource® Dilution Technology. We can make more out of small sample volumes, while keeping ultra sensitive detection by exponential signal amplification via Imperacer®.
 

 

 




 

"Cytokine Storm Biomarkers"

 

Inflammatory biomarkers

Several studies investigating severe COVID-19 cases, cite a hyperactivation of the inflammatory response, leading to a cytokine release syndrom, also called cytokine storm.
Many reports show elevated levels of IL-1, IL-6 , TNF-α and C-reactive protein (CRP), additionally, a protective effect for blood type 0 is discussed.
Read more in the following studies.

 

Furthermore, we provide exquisite bioanalytical biomarker services on different platforms.
Find suited Imperacer®, Simoa®, MSD™ or ELISA biomaker kits or request your custom-designed assay here.

 

Levi, M. et al. (2020)  Coagulation abnormalities and thrombosis in patients with COVID-19. Lancet Haematol. 7(6): e438–e440.

Kermali, M. et al. (2020)  The role of biomarkers in diagnosis of COVID-19 – A systematic review. Life Sci 117788.

Chen, L. et al. (2020) Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Chinese J Tuberculosis Respir Dis 43(0):E005

Guan, W. et al. (2020) Clinical Characteristics of Coronavirus Disease 2019 in China. NEJM. 382: 18

Wang, W. et al. (2020)  The definition and risks of Cytokine Release Syndrome-Like in 11 COVID-19-Infected Pneumonia critically ill patients: Disease Characteristics and Retrospective Analysis. medRxiv

 




 

"20 Years Immunoassay Expertise"

 

Chimera Biotec Celebrates!

Starting in 2000, with our proprietary Immuno-PCR platform Imperacer®, Chimera has specialized in ultra sensitive GLP/GCP bioanalytical support for all phases of drug discovery.

Get your assay! Get excellence!

                    ♦  GLP / GCP test facility
                    ♦  Non-regulated, preclinical & clinical support
                    ♦  Compliant with FDA & EMA guidances
                    ♦  Ultra sensitive immunoassay platforms
                    ♦  Assay feasibility
                    ♦  Full assay devevlopment services
                    ♦  Kit-based services

 

 

 

Ever wondered how
companies come up
with their names?

This is our story:

 

A Chimera is a mixed being in Greek mythology:

“She was of divine stock, not of men, in the fore part a lion, in the hinder a serpent, and in the midst a goat, breathing forth in terrible wise the might of blazing fire.” (Homer, Iliad 6,180 ff.)

Our Chimera is the Immuno-PCR platform Imperacer®, in which antibody-DNA conjugates combine ELISA-type immunoassay setup with exponential PCR read-out:

“She was of ultra sensitivity, in the fore part antibody, in the hinder DNA, enabling forth in outstanding sensitive wise the might of groundbreaking science.”

 

Bring together Imperacer®, AnySource® and Chimera´s 20 years of experience in beyond ELISA sensitive immunoassays, combining ultra sensitivity, broad assay range and minimal sample volume requirement.

That´s why Chimera Biotec: We provide optimal assay development for your target and bioanalysis under GLP/GCP regulations.

 




 

"Bispecific T Cell Engager - Their Role in Immuno-Oncology"

 

 

Here, Ma et al. (2020) describe T cell engagers (TCEs) binding to the tumor marker CEA (serum carcinoembryonic antigen) on cancer cells
and CD3 on T cells in the tumor compartment to form bivalent TCE ternary complex (biTTC).

They use a quantitative systems pharmacology (QPS) model to explore TCE efficiency, identify potential biomarkers
and can even predict patient-specific response to TCE treatment.

 

 

 

 

We routinely develop and validate ultra sensitive PK assays for GLP/GCP regulated bioanalytical sample testing support of bispecific antibody-based therapies, such as TCRs, for treatment of various malignancies.



Chimera´s AnySource® sample dilution minimizes matrix effects, enabling therapeutic antibodies target detection in the presence of ~ 1,000,000-fold excess of endogenous antibodies.

 

We offer complete service packages (PK/PD, Immunogenicity, Biomarker) across multiple platforms.

 




 

"Neurodegenerative Diseases - Bioanalytical Solutions"

 

 

Here, Yoo et al. (2020) suggest soluble Aβ*56 and AβO as potential biomarkers for AD in nasal discharge.

While increased levels in Aβ*56 alone can indicate mild AD, additionally increased AβO levels give hint to a moderate stage.

This suggests soluble Aβ*56 and AβO as potential biomarkers for AD in nasal discharge.

 

 

To address the low oral bioavailability and side effects of levodopa, Arisoy et al. (2020) used nano-sized drug carriers for nose to brain delivery.

The levodopa-coated biocompatible nanoparticles prolonged release up to 9h and improved locomotor activity in Parkinson´s Diesease model in mice.

 

 


 

Please feel free to contact Chimera Biotec’s team of dedicated scientists for more in-depth information. We are looking forward to provide you with the immunoassay to exceed your highest expectations.