RISE offers in vitro analysis to study interactions between the small intestine and substances or microbiota.

We offer the in vitro modell EpiIntestinal to study the small intestine:

EpiIntestinal (MatTek Corporations) is a in vitro model based on human primary cells from the small intestinel The model simulates a human small intestine which one can use to study uptake rate, uptake mechanisms, inflammatory responses, gene expression, cytokine production, toxcicity and interactions with microbiota and more. When studying bioavailability of potential drug substances or effect of probiotica this is a prefered model to choose to be able to screen many candidates fast to be able to choose the best ones earlier in the development phase. The model is more translatable to human situation and correlates better with human clinical absorption data than the older Caco2 model. We are happy to assist you when you deside upon parameters, study design and read outs. Everything can be adjusted according to your needs. 

By screening substances in vitro before going in vivo you will save both money and research animals by finding the best candidates in an earlier part of the development. By choosing the EpiIntestinal model could help translating the in vitro results into real utake in humans, since data from rodents not always are translatable to humans. It is also posible to investigate interactions with microbiota specific for humans. 

When ordered, the coosen model system are put into cultivation for that specific customer project making it important to have all aspects of the study design in place before cultivation starts. When the models are ready, 4 weeks later, they are usually exposed with the test substances for two hours. Samples are then taken from either the supernatant or the cells depending on parameters of interest for the customer. If the study aim to detect anti inflammatory effect in teh small intestine we can both look at cytokine secretion or gene expeession. To ensure that the membrane integrity is high, permeability is tested on each replicate with lucifer yellow as a marker or with TEER. This information will be included in the report together with the parameters of interest for the customer.

The customer is provided with a report including values for parameters of interest for their substances and quality assurance of the membranes. 

1,5 month after accepted tender. Since cultivation of the modelsystems takes 4 weeks we recommend you to discuss study design with one of the contact persons before putting an order ensuring that the right amount of replicatates are used. Exposure time also affects delivery time. Weekends or national holidays will affect the delivery time. 

Information regarding test subtstance need to be discussed before start of cultivation of the model systems. The test substances need to arrive one week befor test start.

All medical devices have to undergo a biological evaluation of biocompatibility to fulfill the requirements in the EU Medical Device Regulation (MDR). We can help you with everything from setting up a biological safety evaluation plan according to ISO 10993 and ISO 14971 to performing the required tests.

The aim of the biological safety evaluation is to ensure that possible negative effects on human health caused by the materials in the product shall be identified and managed. We are a dedicated collaboration partner with solid knowledge about current regulations, available test methods and good test strategies. We are also the only laboratory in Sweden to offer cell based test methods according to the quality system Good Laboratory Practice (GLP) to external customers.

In the EU and in the US, the legislative requirements for biocompatibility of materials in medical devices are similar. The standard series ISO 10993, describing test strategies and – methods to ensure biocompatibility, is combined with the standard ISO 14971, which concerns risk management for medical devices. These two standards form the framework for generating a biological safety evaluation plan.

Generating a biological safety evaluation plan is performed in several steps:

• Planning and executing a biocompatibility evaluation according to ISO 10993-1, choice of suitable methods and waiving of certain tests.
• Toxicological evaluation of included parts and chemical substances according to ISO 10993-17 and relevant regulations.
• Determination of leachables and/or extractables from ceramic, metallic or polymeric materials according to ISO 10993-18.
• Chemical characterisation of included materials with techniques such as FTIR, DSC, XRF, CHN, XRD, surface area determinations, polymer molecular weight determination, etc, according to ISO 10993-19.
• Determination of degradation products from materials according to ISO 10993-9, ISO 10993-13, ISO 10993-14, and ISO 10993-15.
• Biological testing of materials according to ISO 10993-1, such as cytotoxicity, skin sensitization and skin irritation.
• Risk evaluation and risk management plans for residual risk.

RISE has extensive personnel and instrumental resources available, to perform all steps up to a complete biological safety evaluation plan.

Results from testing or evaluation are presented in one or several reports in Swedish or in English as agreed with the customer. For tests performed according to GLP, a study plan is set up before the start of the test.

Stated in the tender and depends on the type of assignment.

In case testing shall be performed, information about the test item(s) is given in a sample submission form submitted to us at RISE together with the test item(s). It is the responsibility of the customer to characterise the test item(s) sufficiently to fulfill GLP requirements.

ISO 10993-series, ISO 14971, ISO/IEC 17025, OECD principles of Good Laboratory Practice

In vitro analyzes to study interactions between material/substances and marine microorganisms.

There are several reasons why it is important to know how marine microorganisms interact or are affected by a sample (chemicals or materials). The test samples could include ingredients to antifouling paint, surface modifications on static structures (to hinder the growth of fouler or biocorrosion), ballast water etc. Depending on the usage of the product different types of testing might be needed to collect the information requested. With our vast knowledge of microorganisms, in both bacteria and microalgae, we can adjust the evaluation according to the customer need. We constantly broaden our library of organisms and test methods. If the customer lacks the possibility to perform laboratory work, we assist in this process, but we can also take on a bigger role in your developmental journey.

Common methods could include toxicity, biofilm (static or flow), gene expression and morphological studies based on microscopy. We also assist with more unique questions involving proof of concept and mode of action. If you have a protocol or a new method, we are happy to assist with evaluation, troubleshooting and validation.

By putting your substances or materials through in vitro testing before going into the field you could have a better screening process and save both time and money by selecting the best candidate in an earlier stage of the development. Is it a new method you are developing, new doors open up if an independent laboratory could repeat and confirm the stability and transferability of the process.

Methods to be used depend on customer need. If you have specific questions related to marine microorganisms/anti fouling/bio corrosion in vitro you are welcome to contact us and set up a meeting to discuss how we can assist you. We are happy to assist in the discussion on which tests that are necessary for your questions and needs, experimental set up, performance, interpretation of results and report.

The customer obtains a report which contains all parameters of requests for their specific samples/methods.

Delivery time depend on the study or project of question. Please contact us for a more specific assessment. New organisms or methods, weekends and national holidays might affect the delivery time.  

Information regarding test substances/materials must be discussed before start of cultivation of microorganisms.

RISE offer in vitro-analyses to study interactions between material/subtances and cell lines.

Many are the reasons to study the effect of substances or materials on cells. It can be materials/substances to be used in or as medicinal products, wound dressing, future pharmaceuticals, supplements etc. Depending on what the product are to be used as, different evaluations are of interest. With vast knowledge in cell and molecular biology we will adjust the evaluation to the customers needs. We bring in new cell lines and methods on an ongoing basis. 

If the customer lacks the laborative resources we will assist with that, but we also have the ability to take on a bigger role in your developmental journey. 

Frequent methods may include but not be limited to; toxcicity, proliferation, gene expression, protein analysis and morphology studies based on microscopy. We will aslo help with more uniqe evaluation methods including proof of concept and mode of action. 

If the customer have a protocol or method, we gladly help you evaluate, troubleshoot and validate it. 

By studying your substances or materials in vitro before going in vivo you will save both money and research animals in the process by choosing the best candidates earlier in the testing. If your method is new, repetition and validation by an independet laboratory open up new posibilities for it. 

Method to be used is completely depending on the customers question. If you have questions regarding cell biology you are welcome to schedule a meeting to discuss your uniqe perspective. We can help with everything from questions, experimental design and performance to interpertation of results. Please contact us for more information regarding how we can help you. 

The customer get a report with parameters of choice. 

Deliverytime depends completely on methods used and whats to be studied. Generally it takes two weeks to start up cells from cryopreservation. In addition to that there is time needed to set up and performe studies of choice. The total time from tender acceptance is around six weeks. Contact us for more specifics. New cell lines, methods and national holidays will affect the delivery time. 

Contact one of the persons listed below for dicussion or price 

Information regarding test subtstance need to be discussed before start of cultivation of the model systems. The test substances need to arrive one week before test start.

RISE offer an in vitro model to study pro, anti and inflammatory attributes of subtances in the signal path of NF-kB.

Inflammatory responses in humens are mainly associated with the NF-kB signaling pathway. This response is triggered by substances from bacteria and virus but also by other types of stress like UV light or chemical substances. When a substance trigger a NF-kB response an inflamation is initiated in the body.

Sometimes when we are sick and have a high activation of NF-kB we want to ease the symptoms related to inflammation (eg. fever) by taking anti inflammatory pharmaceuticals (eg acetyl slicylic acid or paracetamol).

To introduce novel substances or food sources in our diet or local environment it is important to know if these can cause an infammation in persons exposed to them or if they can have the posibility to lower the inflammatory response.

We offer an simple model giving the posibility to study many samples at the same time in an in vitro model. This model can determine if a substance is pro, anti or neutral regarding an inflammatory respons in the NF-kB signaling pathway. 

By evaluating substances in vitro before going in vivo, both reseach animals and money can be saved by choosing the best candidate in an earlier stage of the development.

The model is based on GloResponse™ NF-κB-RE-luc2P HEK293. This is a transformed cell line expressing an enzyme (luciferace) under the NF-kB-promotor. When the NF-kB gene is activated, the enzyme will be expressed. One measures the activation by adding substrate (luciferin) for the enzyme and the end point is luminiscence.

If one is interested in inhibition of this signal patwhay one stimulates the cells with TNF-a to get an enhanced background level before trying to lower this activation with substances of choise. To eliminate false positive, were the effect seen is due to an toxic response leading to cell death instead of lowering readout, this version of the method is coupled with an toxcicity assay as controlls. 

The customer will get a report containing parameters of choice and qulity assurance data of the toxcicity of the substances.

It ususally takes two weeks to start up cells from cryopreservation. More over time for the specific test will add on making the total time of 4 weeks from acceptance of tender. Contact us for a more specific time frame.

Weekends or national holidays will affect the delivery time. 

Information regarding test subtstance need to be discussed before start of cultivation of the model systems. The test substances need to arrive one week before test start.

RISE offers an in vitro method to study the uptake of substances that are to be oraly administred.

We offer two different modells to study uptake in the small intestine:

- Caco2 is the classical in viitro method used to study uptake in small intestine. The modell uses cancer cells originating in the colon. These cells will spontaneously differentiate to someting similar to the small intestine. The membrane integrity are still similar to that of the colon.

- EpiIntestinal is a mor modern method using human primary cells originating from the small intestin. This modell correlate better with human clinical data than Caco2.

We will help you choose the modell fit for your experiments. Study design can be adjusted to fit your whishes regarding concentrations, controlls and exposure time. 

Evaluating substances in vitro befor moving into in vivo will save both research animals and money by eliminate unfit candidates at an earlier time in the development. Testing on EpiIntestinal might also help translate your data to expected uptake in human since the animals usually tested for uptake befor human is rodents. EpiIntestinal correlates better with the human clinical data than the rodents in some aspects.

When ordered, the coosen model system are put into cultivation for that specific customer project making it important to have all aspects of the study design in place before cultivation starts. When the models are ready, 4 weeks later, they are usually exposed with the test substances for two hours. Samples are then taken from  the original solution, lumen and blod side if the models and presented to the customers as Papp values. 

If the substance arent to be found in the lumen or blood side of the modell we will suggest adding on a analysis of the membrane to see if it is associated to the cells or the membrane or if it has been metabolized. 

To ensure that the membrane integrity is high, permeability is tested on each replicate with lucifer yellow as a marker or with TEER. This information will be included in the report together with the permeability of the substances (Papp values).

The customer will get a report including permeability (Papp) for the specific substances and quality controll of the membranes. 

1,5 month after accepted tender. Since cultivation of the modelsystems takes 4 weeks we recommend you to discuss study design with one of the contact persons before putting an order ensuring that the right amount of replicatates are used. Exposure time also affects delivery time. Weekends or national holidays will affect the delivery time. 

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Information regarding test subtstance need to be discussed before start of cultivation of the model systems. The test substances need to arrive one week before test start.

Analysis of endotoxin levels is a crucial part of quality control in biotech, medtech, and pharmaceutical industries. An accurate and precise analysis can help reduce the risk of adverse effects and ensure high quality and safety of biological products.

Endotoxins are components of the outer cell membranes in gram-negative bacteria and when released, can cause serious and sometimes deadly inflammatory reactions in humans and animals. Therefore, it is important to ensure that medical devices, biological and pharmaceutical products and materials are free from endotoxins before use.

At RISE, endotoxin levels are analyzed using a kinetic chromogenic Limulus amebocyte lysate (LAL) method according to Eur.Ph.2.6.14 (method D). The LAL test is based on the coagulation reaction of amebocytes from horseshoe crabs, which react with endotoxins. The test is sensitive and specific for endotoxins and can detect very small amounts.

For the analysis, the Endosafe® LAL-cartridge system from Charles River Laboratories, with FDA-licensed cartridges and the Endosafe® Nexgen PTS™ reader is used. The detection limit for the analysis is 0.005 EU/mL.

We can analyze both liquid solutions and solid materials, e.g. medical devices. Solid materials are extracted according to US Pharmacopoeia chapter 161.

The results are presented in a report with an overview of the detected levels in each sample.

Contact us for price information. Please find contact information below.

Both solid and liquid samples can be prepared and analysed.