BioAssays in vivo

Today’s rapid developments in biologics – including proteins, peptides, therapeutic antibodies, and immunotherapeutics – have resulted in new drug development challenges that require an extensive and in-depth understanding of bioanalysis and immunology and development of GLP, GCLP and GMP compliant assays.
Texcell laboratories expertise provides you with a wide panel of assays for bioanalysis and evaluation of the immune response for biologicals under GLP, GCLP and GMP conditions.


Texcell has developed study plans to detect viruses, vectors or specific gene sequences by qPCR in a variety of different samples and fluids (see list below).

  • Bones, muscles and joints
  • Nerves, spinal cord, pia mater
  • Aerial tract
  • Gastrointestinal tract
  • Urinary tract
  • Reproductive system
  • Blood, lymph, lymph nodes, heart and vessels
  • Adrenal system

For a comprehensive list of tissues, please visit vivo Science, a Texcell company.


Texcell has validated and implemented standardized immunotoxicity tests which are in full compliance with international guidelines and recommendations.

Our portfolio includes large panels of test for assessment of

  • cytokine release
  • drug allergenicity
  • anaphylactic shock
  • cross-priming of auto-immune responses
  • alterations of pharmacokinetics and pharmacodynamics
  • alterations of biological activities

Anti-drug antibody assays (ADA assay) can additionally be performed to exclude undesirable side effects, especially in biotechnology-derived pharmaceuticals such as therapeutic antibodies and growth factors.

Potency Assay

“Determining the biological activity of cell-based immunotherapy products is not easy since the active ingredient is usually composed of whole cells and the activity of these products can generally not be attributed to one specific cell characteristic. The potency (i.e., the quantitative measure of biological activity) of cell-based products can be measured using in vivo or in vitro tests. An appropriately validated potency assay should be based on a defined biological effect as close as possible to the mechanism(s) of action/clinical response.” (EMA/CHMP/BWP/271475/2006 rev.1)

Texcell is developing or transferring custom bioassays with several readout possibilities:

  • In vivo on small animals
  • In vitro in cell lines or primary cells

Results are computed according to the parallel line method (US/European Pharmacopoeia).

Bioassays are used for various purposes, such as:

  • Proof of concept
  • Neutralizing potential of unwanted antibodies against biologicals (ADA);
  • Potency assays for batch release and stability testing


Toxicokinetics/Pharmacokinetics (TK/PK) measures drug concentrations in body fluids during clinical trials (Phases I to III), except viral or DNA vaccines or Gene Therapy (see Biodistribution section). Texcell offers validation of TK/PK assays according to the bioanalytical validation guidelines (ICHQ2(R1), EMA, FDA).

Sample testing is performed under GLP or GCLP (including multisite GLP).

Main Guidelines:

ICH S3A: Note for Guidance on Toxicokinetics: Assessment of Systemic Exposure in Toxicity Studies
ICH S6(R1) Addendum and ICH S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
EMA (2007). “Guideline on the Clinical Investigation of the Pharmacokinetics of Therapeutic Proteins” EMEA/CHMP/EWP/89249/2004.


Tumorigenicity is the tendency for cultured cells to give rise to either benign or malignant growing tumors when infected to in immunologically nonresponsive animals. Assessing and managing the tumorigenicity of all final products is essential in order to prevent ectopic tissue formation, tumor development or malignant transformation elicited by residual pluripotent stem cells after implantation (Kuroda T et al., Biol Pharm Bull. 2013;36(2):189-92.)

Texcell has developed a full range of in vivo assays to assess the tumorigenicity cells monitoring the development of possible tumors in immunosuppressed animals or in in vitro test systems.

Please visit vivo Science, a Texcell company, for more information or for additional tests.


Toxicology studies are performed for the safety evaluation of drugs, chemicals and medical devices and help to identify possible and undesired toxic effects on organs. For this reason, vivo Science GmbH offers a diverse portfolio from single dose to repeated dose and developmental and reproductive toxicology (DART) studies.
Along with the toxicology studies, biodistribution studies can be provided for a closer investigation of a possible accumulation of test substance in organs.
For the assessment of possible tumor formation, tumorigenicity and cancerogenicity studies can additionally be performed and customized according to the needs of our clients.

Medical Devices

Medical devices that are supposed to be contact with the human body are required to be tested on possible interactions and potential undesirable side effects by regulatory authorities. Therefore, medical devices are assigned to different categories dependent on the kind of contact and the contact time to the human body.
Texcell offers in-vitro and in-vivo testing of biomaterials according to ISO 10993 for your medical device of either class I, class IIa/IIb or class III in full compliance with the principles of Good Laboratory Practice (GLP).