Biobank and Bio-Analysis Services
METABOLIC DISEASE RESEARCH
CellMade is a biopharmaceutical company focused on the development and commercialization of early diagnostic and prognostic tests and novel therapeutics to prevent development of Metabolic Disease and related co-morbidities.
The Company is dedicated to inflammation biology. Inflammation is a localized response to injury or infection characterized by the sequential release of inflammatory mediators and the recruitment of circulating leukocytes. Recruited leukocytes become activated at the site of inflammation and release further pro- and anti-inflammatory mediators. Sites of acute inflammation are characterized by the rapid recruitment of neutrophils. Sites of chronic inflammation and characterized by the continuing recruitment of monocytes that differentiate into macrophages.
Chronic inflammation can cause diseases including but not limited to Type II Diabetes (T2DM), Cardiovascular Diseases (CVD) and Chronic Obstructive Pulmonary Disease (COPD). Typically, patients-at-risk are also suffering from chronic overweight or Obesity. Non-Alcoholic Fatty Liver Disease (NAFLD) is a common factor in Overweight/Obese patients developing T2DM and/or CVD and/or COPD. NAFLD is generally considered as the hepatic outcome of the Metabolic Syndrome.
CellMade's lead product, CLM-101, co-developed along with diagnostic and prognostic biomarker signatures (CLM-BM-001 for T2DM; CLM-BM-002 for CVD and CLM-BM-003 for COPD), is evaluated for indications in the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD, NASH <5%), potentially overcoming later development of T2DM and/or CVD and/or COPD.
"I'm not obese, I'm just big boned". Is there truth to heavy weight because of big bones and big frame? Not really. Naturally, from a medical perspective, there is no such thing as being "big boned"; sadly, what is true is the endemic problem of overweight and Obesity. According to the OECD, 34.6% of the adult population in the EU 27 countries is overweight, and 15.5% is obese.
Even more startling is the noxious chain effect ignited by Obesity, which is correlated to the Metabolic Syndrome and its hepatic outcome, Non-Alcoholic Fatty Liver Disease (NAFLD), in turn associated with a broad spectrum of co-morbidities, including T2DM, CVD and COPD.
The scientific evidence on the looming pandemic of Obesity is now overwhelming. It is thought that the spreading of the disease is mediated via circulating inflammatory messengers. As in any degenerative disease, early diagnosis is the key to avoid harmful, and even deadly, effects.
There is high demand for a non-invasive, high-accuracy diagnostic and prognostic approach. CellMade identified and validated a set of atypical blood lipids that allow for discrimination between the various stages of NAFLD enabling to predict patient's risk profile and reactivity to treatment schedules.
To improve the sensitivity and specificity of the identified blood lipids, an algorithm integrating all independent and significantly altered variables was set-up within a single mathematical model to calculate a unified patient’s risk prediction. For disease staging, the presence of additional inflammatory components integrated other inflammatory variables into the analytical approach and the mathematical model.
The successful validation of the biomarker signatures represents a cornerstone advancement to address the societal challenges related to the Obesity pandemic and the development of associated comorbidities such as T2DM, CVD and COPD. Early diagnosis will overcome the costs issues affecting the current clinical scenario, as the disease development is still reversible and could be addressed therapeutically.
The Unmet Needs
The ever-increasing prevalence of Obesity affects millions of people worldwide. The Metabolic Syndrome and its hepatic manifestation, NAFLD-NASH is a key pathological condition triggered by the noxious biochemical pathways of Obesity. Obesity, Metabolic Syndrome and NAFLD-NASH are further related to downstream comorbidities such as T2DM, CVD and COPD. Despite the high unmet medical needs, there are currently no approved drugs for treating NAFLD-NASH. The current main recommendation is lifestyle modification, which is only partially effective.
We at CellMade believe in Open Innovation and therefore established a dedicated range of laboratory services, derived from our own research activities, that can help scientists in further developing tools for Metabolic Disease.
Recent but spectacular advances in –omics disciplines and in bioinformatics lead to yet another important next step for life sciences: Systems Biology (Or: Translational Medicine), targeting pathways, cells, organs and complete organisms by integrating experimental data with computational approaches. Systems biology combines concepts from different scientific and analytical disciplines to obtain an integral understanding of complex biological systems.
Better understanding of underlying mechanisms of life open immense perspectives for a better understanding of human disease. Translational Medicine will have a profound impact on medical research and allow for the development of new, innovative therapies.
Deeper Cellular Insight through Translational Medicine
Different patients with the same pathology do not respond to drugs in the same way. The industry is moving away from a one-size-fits-all approach to more personalized medicine, but to achieve that objective, a deeper insight into biological systems is necessary. CellMade develops Translational Medicine, building multi-disciplinary teams enabling more innovative biomarker and drug discovery.
How can Translational Medicine speed up drug discovery and development? The unique CellMade approach
CellMade has taken the Translational Medicine approach, which considers biology as a continuously communicating network of different cellular systems. If the communication within a cell or between different types of cells is disturbed at one or more levels, pathology can develop. The idea is that we should have a better understanding of the biological network and possibly on how biological networks communicate with each other, before adapting molecules to different patient groups. It is a move away from a one-size-fits-all approach towards more personalized medicine.
Within CellMade we have brought together a multi-disciplinary team from cell biologists, analytical chemists to bioinformatics specialists in an attempt to achieve a better understanding of biological systems. The data generated are entered into a logic-based mathematical model, thereby helping to understand the way the communication network is working, how it reacts and adapts to a defined perturbation, and how these effects could be counteracted. Ultimately, these experiments deliver a better insight into the mechanisms of action of new drug entities and simultaneously allow for identification of predictive biomarkers.
There has been growing recognition, by regulatory bodies, that in order to fully capitalize on the advances in genomics, and to accelerate the development of personalized diagnostics and therapeutics, high-quality biobanks are required. High-quality refers to (i) biological quality of obtained samples, (ii) quality of associated clinical data, and (iii) the ethical and legal status under which samples are obtained. Historically, many biobanks were created on an ad-hoc basis by interested researchers willing to fulfill a specific set of objectives and tissue collection. Storage conditions, Information Management Systems, Ethical and Legal policies varied depending on the purpose of the biobank. Many specimens are of limited use for modern research due to age of samples, method of fixation, absence of associated patient information and poor quality of tissue specimens. Similarly, the donor consent may be required to perform certain types of research on samples, but in some biobanks obtaining such information can be impossible as traceability was never assured. Furthermore, the extent of information collected with specimens can be limited and variable. The heterogeneity of biobanks limits the ability to pool and compare bio-specimens.
One of the greatest challenges facing biobanking is the fact that small variations in bio-specimen acquisition, handling, processing and storage can produce variations in the quality and the reproducibility of results. The standard operating procedures used by the bio-specimen collection network enables to pool samples acquired, handled, processed and stored in the same manner. Researchers will be able to measure genuine biological differences rather than sample-to-sample variability.
- CellMade created a bio-specimen collection network with standardized procedures for acquisition, preservation and storage of clinically annotated samples
- Best Practices for Bio-specimen Resources have been implemented including a sophisticated security and information technology infrastructure
The biobank contains demographic data, diagnosis, treatment and follow-up of patients. Our biobank also develops collections of matched, healthy samples. It is important to provide matched healthy control samples as the development of biomarkers depends on the diagnosis of disease knowing the scope of normal variation versus pathological deviation. Indeed, by understanding what is “normal”, it may be possible to identify biomarkers that can be used for early detection of inflammatory disease. Establishing a normal profile can be extremely complex. While obtaining blood samples from healthy patients may be relatively straightforward, the prospective and invasive collection of healthy tissue for research is far much challenging.
The biobank, is likely to deliver a first wave of personalized diagnosis and therapies and services through a greater understanding if individual risk profiles and variability to drug response as well as rates and occurrence of drug toxicity. The creation of the Biobank with collections of disease and matched healthy control samples leads to a better understanding of the scope of normal human variation which makes it possible to identify biomarkers that can be used for early detection of inflammatory disease. The main advantage of working with the disease-focused biobank is gaining access to defined disease and healthy control samples enabling rapid development of new biomarkers.
CellMade developed its Biobanking activities to create primary cell models, 3D and co-culture models, cell-based assays for target discovery and validation, screening of novel compounds, modelling of pharmacokinetic effects of new therapies as well as discovery and validation of biomarkers. The different products and services published on this website are all based upon the use of our Inflammation disease-focused biobank.
CellMade Disease-focused biobank – Valuable Biological Ressources for Discovery and Validation of Biomarkers in the field of Metabolic Diseases
- Healthy ("Normal") Samples
- Disease-focused Samples
- Obesity (+/- NAFLD-NASH) – Diabetes Type II
- Obesity (+/- NAFLD-NASH) – Cardiovascular Disease
- Obesity (+/- NAFLD-NASH) – Chronic Obstructive Pulmonary Disease