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Analysis of protein, enzyme and biological pharmaceuticals

Analysis of protein, enzyme and biologic
bottles in labratory

RISE specialize in a broad range of protein analytical testing techniques to facilitate and speed up the development of future medicines.

Are you working with research on or production of proteins, enzymes, or biological pharmaceuticals? We offer advanced, strategic, and experimental analysis support for you to fully understand your protein. We support projects in both early and late preclinical phases, as well as in the clinic, and can support you with protein analysis either within a single analysis context, to meet specific analytical needs, or as analytical support through process development.

When working with biological pharmaceutical products, early characterisation of the selected pharmacological target has been identified as one of the most important success factors, resulting in reduction of both project time and costs.  The ability to rapidly identify stability issues, detect modifications and identify contaminants at an early stage of product development, are all key to effective process development of biological products, where toxic, unstable or inactive substances can be deselected at an early stage. At RISE, we are specialized in numerous protein analysis techniques such as high resolution mass spectrometry (LC-MS, LM-MS/MS), chromatography (LC-UV, SEC, RP, IEX), electrophoresis (SDS-PAGE) and spectrophotometric methods and ELISA. With our help, you can rapidly gain insight into:

  • What molecular weight does the target protein and other protein related substances have? Is it in line with what is expected?
  • Is the protein intact?
  • Is the protein truncated?
  • What is the purity grade in the sample?
  • Is the amino acid sequence correct? A peptide map, where the protein is degraded with one or more enzymes followed by LC-MS/MS analysis could give the answer.
  • Is the protein active?
  • Is the protein stable?
  • Does the protein aggregate?
  • What charge profile does the protein possess?
  • Are there post translational modifications (for example glycosylation, phosphorylation, oxidation, deamidation) and, if so, where and what kind are they?
  • Is the protein homogenous or heterogenous?
  • What other protein species are present in the sample, apart from the target protein?

If you have a protein analytical challenge, we will help you find the best strategy and methods to provide the right data to answer your question. In doing this, RISE can offer advice and support to meet quality and regulatory requirements from authorities such as FDA and EMA. Do not hesitate to contact us if you wish to discuss your project further.

Jenny Blomqvist

Försöksledare/Projektledare
+46 10 516 62 50 Read more about Jenny
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Division (OLD): Division Bioeconomy Offer-pages: End-to-end CDMO services for biologics Division: Division Bioeconomy Drug development

Effect on permeability, membrane integrity, toxcicity, inflamation, gene expression and microbiota in small intestine

Name of service (page headline, shown in promos – maximum of 70 characters incl. spaces): EpiIntestinal In vitro modell Lead (include SEO-words and the main benefits for your target groups. Stick to one paragraph, maximum 2-3 sentences):

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

Purpose/Benefit:

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. 

Method (what/which methods are used to perform the service):

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.

Delivery (what does the client get after performed service – e.g. a report, certificate etc.):

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

Delivery time:

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. 

Area:
Chemical and biological analysis
Pharmaceuticals
Medical devices
Preventive healthcare
Field measurements: No Price type: 1 Division: Division Materials and Industry Preparation: Description of preparation Preparation information:

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.

Certification and marking: Not applicable Type of service: Testing / Analysis / Evaluation Instrument: Not applicable General area: Not applicable Order information: Please contact one of the persons listed at the bottom for ordering or discussions. Divison (OLD): Division Materials and Industry Delivery level: Not applicable
lovisa.bodin@ri.se
/en/about-rise/operations/mission-governance/policy-documents/privacy-policy
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Drug development Sekundär områdes navigation:
Biotechnology
Food
Tjänstetyp tagg: Provning

PLATINEA: Platform for Innovation of Existing Antibiotics

PLATINEA
Platinea workshop 2025

PLATINEA is a multisectoral collaboration platform with the aim to preserve and enhance the value of existing antibiotics. PLATINEA consists of 23 partners from academia, authorities, industry and healthcare. The common goal is to ensure that antibiotics available today are used in the best way and to ensure accessibility to important antibiotics.

Workpackages 1 and 4
Completed
Infection control Pharmaceuticals
Until September 2026
99,107,836 SEK
Division: Do not use - Division Built Environment

The project is structured in six work-packages:

  1. Knowledge gaps and requisites. Purpose: To identify knowledge gaps and map the need of various antibiotics in the Swedish context.
  2. Optimization Studies. Purpose: To generate new knowledge to inform rational and individualized use of antibiotics.
  3. Application of Knowledge. Purpose: To conduct intervention studies and implement new methods for rational antibiotic use, and establish a national collaboration for clinical studies.
  4. Value and Availability. Purpose: To increase the availability of antibiotics in Sweden through analyses of costs related to shortages, mapping of delivery chains and support to implementations of measures against shortages.
  5. Precision Health through AI. Purpose: To create solutions that enables data driven precision medicine for antibiotic stewardship.
  6. Project Management & Coordination. Purpose: To manage and administer the project, as well as to coordinate activities within the other work packages and communicate with external parties.

 

Denny Mahlin

Forskare
+46 10 722 33 25 Read more about Denny
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Francisco Salva Serra

Forskare
+46 73 023 87 91 Read more about Francisco
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3. Good health and well-being
10. Reduced inequalities
12. Responsible consumption and production
Cortexa Life Science TAMRO / Swedish Association of Pharmaceutical Distributors (LDF)
Projekt logo: PLATINEA Project end date: Drug development Sekundär områdes navigation:
Artificial intelligence
Data Science
Innovation management

Anti inflammatory attributes in the NF-kB signaling path

Name of service (page headline, shown in promos – maximum of 70 characters incl. spaces): Anti inflammatory attributes Lead (include SEO-words and the main benefits for your target groups. Stick to one paragraph, maximum 2-3 sentences):

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

Purpose/Benefit:

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.

Method (what/which methods are used to perform the service):

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. 

Delivery (what does the client get after performed service – e.g. a report, certificate etc.):

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

Delivery time:

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. 

Area:
Chemical and biological analysis
Pharmaceuticals
Medical devices
Preventive healthcare
Anti Inflammatory properties
Field measurements: No Price type: 1 Division: Division Materials and Industry Preparation: Description of preparation Preparation information:

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.

Certification and marking: Not applicable Type of service: Testing / Analysis / Evaluation Instrument: Not applicable General area: Not applicable Order information: Please contact one of the persons listed at the bottom for ordering or discussions Divison (OLD): Division Materials and Industry Delivery level: Not applicable
lovisa.bodin@ri.se
/en/node/9710
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Drug development Sekundär områdes navigation:
Biotechnology
Food
Tjänstetyp tagg: Provning

In vitro-permeability in the small intestine evaluated by Caco2 or EpiIntestinal

Name of service (page headline, shown in promos – maximum of 70 characters incl. spaces): In vitro-permeability Lead (include SEO-words and the main benefits for your target groups. Stick to one paragraph, maximum 2-3 sentences):

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

Purpose/Benefit:

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.

Method (what/which methods are used to perform the service):

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).

Delivery (what does the client get after performed service – e.g. a report, certificate etc.):

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

Delivery time:

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. 

Area:
Chemical and biological analysis
Pharmaceuticals
Medical devices
Preventive healthcare
Healthcare and social care
In vitro-permeability
Field measurements: No Price type: 1 Priceinformation:

Kontakta någon av personerna nedan för prisuppgift

Division: Division Materials and Industry Preparation: Description of preparation Preparation information:

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.

Certification and marking: Not applicable Type of service: Testing / Analysis / Evaluation Instrument: Not applicable General area: Not applicable Order information: Please contact one of the persons listed at the bottom for ordering or discussions Divison (OLD): Division Materials and Industry Delivery level: Not applicable
lovisa.bodin@ri.se
/en/node/9710
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Drug development Sekundär områdes navigation:
Metrology
Biotechnology
Tjänstetyp tagg: Provning

Can nanoparticles kill bacteria?

FORMAMP
Nanoparticles of lipids -Cubosomes

Many infection-causing bacteria have developed a strong resistance against commercial available antibiotics and there is a great need for novel innovative treatments. In a sub-project of FORMAMP, antimicrobial peptides were loaded into lipid nanoparticles for protection and delivery of these sensitive bio-molecules.

Project participant and project coordination
Completed
Formulated products Infection control
Not applicable
5 yrs
Division: Division Bioeconomy

Aim

In this project the use of lipid nanoparticles were investigated for delivery and protection of antimicrobial peptides.

Challenge

Due to decades of exposing pathogenic bacteria to non-lethal doses of antibiotics, they have developed a strong resistance against these drug molecules. There is a great need for new and efficient antibacterial drugs and the need will most likely increase in the future.

Solution

The bacterial killing efficiency of the peptide loaded nanoparticles were investigated using in vitro and ex vivo models, as well as the bacterial killing mechanism. Results showed that the nanostructure of the particles strongly affected their bacterial killing efficiency. Particles with a cubic nanostructure (“cubosomes”) were found to be most effective. They protected a protease sensitive antimicrobial peptide (LL-37) from enzymatic degradation, resulting in a significant improved bacterial killing after enzyme exposure, compared to pure peptide.

Effect

A new drug delivery system were designed for antimicrobial peptides, made of lipid nanoparticles, which protected them from enzymatic degradation, resulting in more efficient killing of pathogenic bacteria.

Ulla Elofsson

Assoc. Professor
+46 10 516 60 40 Read more about Ulla
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3. Good health and well-being
Project end date: Medtech Sekundär områdes navigation:
Drug development
Composites
Biotechnology

FORMAMP - Innovativ Nanoformulering av Antimikrobiella Peptider

FORMAMP

Kraftiga användning av antibiotika under de senaste årtiondena har lett till att bakterier har utvecklat resistens vilket har orsakat spridning av livshotande sjukdomar. Inom FORMAMP har nanoteknologi i kombination med antimikrobiella peptider ytnytttjats för att utveckla innovativa läkemedelsformuleringar för lokal behandling av infektioner.

Koordinator och forskningspartner
Completed
Formulerade produkter Läkemedel Medicinteknik
Ej tillämpbart
4 år
10.5 MEuro
Division: Division Bioekonomi

Syfte och mål

Det långsiktiga målet för FORMAMP-projektet är att förändra behandlingsstrategierna för infektionssjukdomar och minska spridning av multi-resistenta bakterier.  

Utmaning

Antibiotikaresistens

Lösning

De specifika målen med projektet var att utveckla nya och innovativa formuleringsstrategier för lokal administrering, baserade på kombinationen av nanoteknologiska bärarsystem och antimikrobiella peptider, för behandling av infektionssjukdomar orsakade av bakerier såsom Pseudomonas aeruginosa, MRSA (Methicillin-resistant Staphylococcus aureus) och MTB (Mycobacterium tuberculosis). De kliniska indikationer som har adresserats är hudinfektioner och infektioner i brännsår samt infektioner i lunga såsom cystisk fibros och tuberkulos. Flera av dessa indikationer involverar bildandet av biofilmer, vilket drastiskt försämrar effekten hos tillgängliga behandlingsalternativ. Ett viktigt mål för projektet var därför att utveckla behandlingsstrategier som också tar hänsyn till den problematik som dessa biofilmer orsaker.  

Effekt

Minska spridningen av resistenta bakterier

Ulla Elofsson

Assoc. Professor
+46 10 516 60 40 Read more about Ulla
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3.Hälsa och välbefinnande
Project end date: Läkemedelsutveckling Sekundär områdes navigation:
Bioteknik
Komposit
Kemiska processer och produkter

3D-Bioprinting and additive manufacturing

3D-Bioprinting
3d bioprinting

Through 3D-printing it is possible to build biological structures by combining a biological, or synthetic material, with living cells. 3D-printing can e.g. be used to evaluate biological responses to pharmaceuticals or chemicals and can also be used in the development of future human spare parts. Within the manufacturing process, RISE develops competence and studies the characteristics and functions of 3D-Bioprinting systems.

Laboratory testbeds (LT)
Västra Götaland Region

Patrik Stenlund

Forskare
+46 10 516 58 30 Read more about Patrik
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Off
Division: Division Bioeconomy

The 3D-printing technology, also known as additive manufacturing, are used to build structures or components layer by layer. When it comes to 3D-Bioprinting, living cells and support materials are combined to build structures similar to living tissues. An interesting aspect is that the printed structures can be used as systems for testing different biological effects, e.g. those of not fully developed pharmaceuticals, and chemicals in general. In the long term it is believed that 3D-Bioprinting may advance the development of transplants that can replace damaged or failing tissues and organs.

At RISE we perform research on new materials and implementations of 3D-Bioprinting within e.g. cancer research. The research projects are done in collaboration with medical industries and clinical research groups. Apart from 3D-Bioprinting, the establishment includes research and development of 3D-printing of a broad variety of materials, with a focus on health technical implementations, where surface modification, material characteristics, modeling, and geometry assurance hold great value.

We offer development of methods and printable materials and functionalize them to suit the specific application. We have a large infrastructure of different printing technologies within the institute. Lastly, we also offer characterization and evaluation in vitro and in vivo.

Health and Life Sciences
Additive manufacturing Life Science Pharmaceuticals
Not applicable
2019
Division (OLD): Division Bioeconomy Medtech Sekundär områdes navigation:
Additive manufacturing
Medtech
Biotechnology
Biobased materials
Drug development

New drug could help with neurologic conditions

Drug development

When a drug is going to be developed, not only does an active substance have to be developed - it must also be an effective drug preparation, so that the substance can be properly absorbed by the body. RISE is collaborating with the pharmaceutical company Umecrine Cognition, which is developing an effective new drug, which can help patients who have hitherto received inadequate treatment.

The pharmaceutical company Umecrine Cognition develops drugs for neurological disorders of the central nervous system, such as the disease hepatic encephalopathy. It is a serious neurological and psychiatric condition associated with liver disease, which in the worst case can lead to death. There is currently no approved treatment for these neurological disorders.

How can we help you?

RISE offers expertise and support along the entire drug development process. Fill out the form and we will be in touch!

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Problem solving through lipids

But there are more challenges than that – the substances you work with in pharmaceutical products are, in many cases, sparingly soluble. This problem has been solved by developing a dosage form with significantly better solubility, thanks to the addition of lipids which have been shown to produce better results than other types of formulations previously tested.

"The lipids give us amazing opportunities to dissolve sparingly soluble substances. At the same time they are taken care of by our physiological digestive system for the absorption of fats", says Nicolaas Schipper.

Nicolaas Schipper

Head of manufacture
+46 70 217 78 20 Read more about Nicolaas
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Drug development