Biomarker is a “biological indicator” used to measure onset and progression of a disease or as a marker of drug safety such as body temperature, blood pressure and heart rate.
Compared with biochemical and histological biomarkers, imaging biomarkers have the advantage of remaining non-invasive and being spatially and temporally resolved. Imaging biomarkers play an increasing role in major medical areas and drug development as they can be used for early detection of diseases, patient stratification, and provide an objective assessment for the response to treatment.
At Invicro, we develop novel Imaging biomarkers (i-Biomarker) to:
- Determine if the candidate drug reaches and engages the target
- Quantify the relationship between administered dose and target engagement
- Investigate the relationship between target and disease
- Demonstrate dose-dependent functional effects of the drug candidate
- Define the ‘therapeutic window’ to optimise dose selection and minimise side effects
Invicro follows a structured and risk-management approach to i-biomarker development encompassing target/compound characterisation (e.g. Bmax, Kd determination), compound selection (in silico biomathematical model, bioanalysis of unlabelled compounds distribution), compound design (custom synthesis), radiolabelling with PET or SPECT isotope of suitable half-life, evaluation in preclinical species (e.g. rodents, non-human primate) and quick translation for clinical evaluation.
Invicro has developed and implemented several imaging biomarkers to Good Manufacturing Practice (GMP) standard. We have the capability and experience to help identify, evaluate, develop and implement biomarker candidates for use in both preclinical models and clinical (in humans) studies.
Invicro offers i-Biomarker development for key therapeutic areas including neuroscience, oncology, inflammation, cardiology and respiratory diseases. For a complete list of all i-Biomarker available from Invicro, please click here.
Reliable and sophisticated chemistry underlies successful radiotracer studies and is an essential part of discovery and translational imaging. Invicro’s chemistry team has expertise in radiolabeling a wide range of compounds to support nonclinical and translational research.
- small molecules
- antibodies and antibody derivatives
Invicro’s capabilities include:
- Strategy and method development for novel radiolabeling, including large array of labeling techniques, allowing rapid labeling validation for novel compounds
- Synthesis of PET and SPECT radiopharmaceuticals
- A dedicated state-of-the-art cyclotron facility for production of short-lived isotopes
- Quality control and immunoreactivity assays for tracer validation
- Cell and/or tissue binding and cell internalization assay method development
Click here to inquire about radiolabeling and related studies.
Experienced in projects with the following isotopes:
PET Isotope 11C 68Ga 18F 64Cu 89Zr 124I 52Mn Half-life 20.3 min 67.7 min 109.8 min 12.7 hours 78.4 hours 4.2 days 5.6 days
SPECT Isotope 99mTc 123I 188Re 203Pb 67Cu 201Tl 111ln 67Ga 186Re 177Lu 131I 125I 75Se Half-life 6.0 hours 13.2 hours 17 hours 51.9 hours 61.8 hours 72.9 hours 2.8 days 3.3 days 3.7 days 6.7 days 8.0 days 59.4 days 119.8 days
Other Isotopes 213Bi 90Y 225Ac 32P 3H 14C Half-life 45.6 min 64.1 hours 10.0 days 14.3 days 12.3 years 5730 years
In addition to the above isotopes, we also support conjugation with fluorophores as well as ‘cold’ radiolabeling with non-radioactive elements.
Invicro’s experience and expertise has been applied to over 70 radiotracer INDs and covers a broad range of targets including:
5HT2a 5HT2a Adenosine A2a CB1 Cholinergic transporter D2/D3 market for intrasynaptic dopamine (SPECT) DAT & SERT Dopamine D2/D3 (PET) GABA GlyT1 H3 M2 muscarinic receptor mGluR 5 antagonist NET Neuroinflammation PBR (TSPO) NK1 PDE10 SERT -amyloid protein Tau VMAT2 4β2 nicotinic agonist
Radiotracers are produced internally at three US sites and one UK site. Local distribution is available (please inquire for information/availability).
The Invicro chemistry team has extensive expertise in the production and distribution of radiopharmaceuticals in the US, following GMP, USP 823, and CFR part 212 regulations. We can produce multiple PET and SPECT tracers per day on the scale needed to satisfy clinical and non-clinical studies.
In addition to internal production, Invicro has expertise in the set up and management of radiotracer production sites in the United States, Europe and Australia. This includes:
- Technical site set up
- Production and quality control validations
- Trouble shooting assistance
- Batch record creation and review
Contact us for more information.