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Cell Biology Products

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.

Value Proposition

"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.

OPEN INNOVATION

We at CellMade believe in Open Innovation and therefore established a dedicated range of products,  derived from our own research activities, that can help scientists in further developing tools  for Metabolic Disease. 

HUMAN-ORIGIN CELL MODELS FOR METABOLIC DISEASE RESEARCH

Introduction

The establishment of biologically relevant in vitro approaches is becoming increasingly important as objections to animal experimentation continue to rise. Normal and Diseased Human Primary cells are a good alternative to animal experimentation and can be used as a basis to develop more complex cell models. However, obtaining viable primary cultures from a tissue sample and maintaining it for experimental purposes is a major challenge. Based on our proven laboratory protocols and extensive practical experience from many years of primary cell culture, our products facilitate your human tissue research.

Quality Control

Normal Human Primary Cells test negative for HIV-1, Hepatitis B&C, mycoplasma, bacteria, yeast and fungi. All products are performance tested. A certificate of analysis is delivered with each product purchased. Cells performance is guaranteed as indicated, only when used in combination with the appropriate media & reagent systems. All products are for RESEARCH USE ONLY.

Functionally Characterized

Standard Quality Control tests for the presence of cell specific markers, such as the presence of the von Willebrand factor and Dil-AC-LDL uptake, typically performed when isolating endothelial cells proof the purity of the isolated lot of cells but no specific biological functionality of the lot. Within the functionally characterized lots of cell isolations, this standard quality control is complemented with a screen to measure reactivity of the isolated lot of cells to important cellular signaling pathways. The functionally characterized lots are proven to be biologically functional cells, and give an additional guarantee for more meaningful results when using primary cell models.

Primary Cells – Principle(s) and Advantage(s):

Because of the difficulties and high costs associated with obtaining human tissue and cell samples for drug research purposes, pharmaceutical R&D has come to rely on non-human biology-based testing and computational prediction methods for drug target research, and safety and efficacy screening of potential new therapies. This has led to significant unreliability in predicting drug behavior in man, contributing to high failure rates in clinical development. For this reason, we offer drug discovery researchers to gain easy access to human primary cells and co-culture systems, and to use these systems to identify biomarkers that could be reliable indicators of drug behavior in vivo.

By generating data from human primary cells in early drug discovery, we enable better candidate selection decisions, improve the design of preclinical studies and help to de-risk clinical development stages. Human primary cells are aimed at improving the safety and efficacy screening of new medicines. Typically, drug R&D teams can use our cell products for target validation, biomarker and companion diagnostics discovery in addition to drug safety and efficacy screening in order to obtain reliable data that accurately reflects the human in vivo situation. Human primary cell models “humanize” drug discovery.

Primary cells are freshly isolated from tissues of interest and better represent human biology. Limitation of lot-to-lot variability is guaranteed via functional characterization of isolated cells. Functional characterization guarantees maintenance of in vitro biological activity. The quality of biological activity of cells depends on control of tissue acquisition procedures such as time of collection, method of transport and others all highly influencing the final quality of primary cells. In other words, quality needs to be expressed in biological functionality.

Suggested reading:

  1. Robert A. Coleman, “Human Tissue in the Evaluation of Safety and Efficacy of New Medicines: A Viable Alternative to Animal Models?ISRN Pharmaceutics, vol. 2011, Article ID 806789, 8 pages, 201 doi:10.5402/2011/806789

CELL CULTURE MEDIA AND REAGENTS

Basal Media and Cell Culture Reagents

MCDB media were designed for low-protein or serum-free growth of specific cell types using hormones, growth factors, trace elements and in some cases low levels of charcoal stripped and dialyzed fetal bovine serum; Each medium was formulated to provide defined and optimal growth and nutritional environment selectively promoting growth of specific cell types. It is highly recommended to review literature for further information concerning cell culture media, supplementation, type of culture and degree of chemical definition required.

All cell culture media and reagents are For Research Use Only.

Addition of growth supplements to yield completed growth medium should be performed just before starting cell culture. The nature of the supplement(s) strongly affects storage conditions and shelf life of the medium.

Quality Control

Cell Culture Media test negative for mycoplasma, bacteria, yeast and fungi. All products are performance tested. A certificate of analysis is delivered with each product purchased.

 

WArranty, SPECIFICATIONS, HANDLING AND SAFETY CLAIMS

Warranty

CellMade warrants to the original purchaser, the performance of its products as stated on the product sheet only when using the appropriate CellMade Culture Media, Reagents and the specific protocols delivered with each product. Our obligation under this warranty is limited to, at our option, replace defective products. CellMade takes no responsibility for damage to merchandise in transit. All such claims must be submitted to the carrier. This warranty shall not apply to misuse, negligence, accidents, modifications, or any unauthorized use. In addition, CellMade shall not be responsible to the original purchaser or any other party or parties for bodily or property loss, damages, or injuries of any kind or nature through either direct or indirect use of the product. This warranty is made expressly in lieu of any and all other warranties, expressed or implied, or statutory as to the merchantability, fitness for purpose sold, description, quality, or any other matter. All other such warranties are specifically excluded. 

Product Specifications

CellMade makes every effort to provide accurate product specifications. However, our continuous efforts of product improvements may change listed specifications. Thus, specifications are subject to change without notice.

Handling and Safety claims

All presented products are for RESEARCH USE ONLY. Not approved for human or veterinary use, for application to humans or animals, or for use in vitro diagnostics or clinical procedures.

WARNING: PRODUCTS contain human origin material, treat as potentially infectious. Each cell product is tested for the absence of HIV-1, HIV-2, Hepatitis B Virus and Hepatitis C Virus using Polymerase Chain Reaction (PCR). Testing cannot offer complete assurance that HIV-1, HIV-2, Hepatitis B Virus and Hepatitis C Virus are absent. All human origin material should be handled at a Biological Safety Level 2 to minimize exposure of potentially infectious products, as recommended in the CDC-NIH Manual, Biosafety in Microbiological and Biomedical Laboratories, 1999. For further information, please contact your Site Safety Manager, or our Technical Services.