During the last decade, a number of advances have been made in the area of gene therapy. In December 2017, FDA approved the first gene therapy product for an inherited disease. This drug can be used to treat patient suffering from Leber congenital amaurosis type 2 (LCA2), a disease that has no effective treatment. Children born with LCA2 have poor eyesight which gets progressively worse, with most children losing their vision completely before adulthood. The disease is caused by loss-of-function mutations in the in the RPE65 gene, which the drug Luxturna can compensate for by introducing a functional copy of the gene administered through an adeno-associated virus (AAV)-based vector.

15 January 2020

Today, gene therapy is primarily available in research settings, but the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and China are all beginning to approve gene therapy products.

Every day there’s a new development and numerous research studies and clinical trials are under way to test gene therapy as a treatment for complex diseases (such as different types of cancer, genetic diseases, and infectious diseases).

8 January 2020

Gene therapy is a technique that works to modify a person’s gene(s) to treat or cure a disease. This technique may allow doctors to treat a disorder by inserting a gene into a patient’s cells to help fight a disease instead of using drugs or surgery. For gene therapy to be successful a safe delivery of genetic cargo is key. There are multiple viruses that can be used to deliver genes to cells and each virus has its advantages and disadvantages.

Emerging as the predominant vector

Gene therapy studies using Adeno-Associated Virus (AAV) vector have shown significant progress in human gene therapy and AAVs have emerged as the predominant vectors for delivering genes of interest to target tissues with improved specificity, efficiency, and safety.

AAV vectors are bioengineered tools that use a non-enveloped virus to transport modified genetic material safely into tissues and cells impacted by otherwise difficult-to-treat conditions. These vectors deliver their genetic cargo into tissues, after which the modified genes will create new instructions for those tissues and help treat disease. 

18 December 2019

At the highlight of the bioanalytical year, the 12th European Bioanalysis Forum - "A New Bioanalytical Earthrise", our bioanalytical expert, Anna Laurén, presented two presentations on behalf of the EBF.

The slides from these presentations are now available for download below and thru the official EBF website.

18 December 2019

Please note the opening hours during Christmas, New Year - and Twelfth Night holidays for the Svar Life Science offices and the Wieslab diagnostic services laboratory below. We wish you all the warmest of holiday cheer! 


Svar Life Science

Svar Life Science office hours (CET) during the Christmas, New Year- and Twelfth Night holiday season:

• December 23, 2019 office closed after 14:00pm

• December 24, 25 and 26, 2019 office closed

• December 31, 2019 office closed

• January 1, 2020 office closed

• January 6, 2020 office closed

Wieslab Diagnostic Services

During Christmas, New Year - and Twelfth Night, Wieslab Diagnostic Services Laboratory is open as usual.

Opening hours:

• December 20, 2019 from 08:00 to 16:00

• December 23, 08:00 to 14:00

  • 27 and 30, 2019 from 8:00 to 16:00

• January 2-3, 2020 from 8:00 to 16:00 

As we will have reduced workforce during the holiday season, our reporting times may be slightly longer than usual for certain analyses.

During this period, acute testing service will be of priority

12 December 2019

An important part of any gene therapy project is choosing a vector that can safely and reliably deliver the transgene to the target cells in the patient. Most commonly, this is accomplished through the use of viral vectors, although non-viral vectors are also used.

11 December 2019

Therapeutic antibodies are increasingly used to treat different types of cancer, including breast cancer, the second most commonly diagnosed cancer worldwide. Many of these therapeutic antibodies work, at least in part, by activating antibody-dependent cell-mediated cytotoxicity (ADCC). In ADCC, an effector cell actively lyses a target cell that is bound by a specific antibody.

Trastuzumab is an anti-HER2 therapeutic antibody commonly used for treating HER2 positive breast cancer patients. Svar has developed a sensitive and specific functional cell-based iLite® ADCC HER2 assay.

In this study, the authors have analyzed this assay for some of the most critical parameters included in clinical bioassay characterization: serum tolerance, cut-point determination, neutralizing antibody (NAb) assay sensitivity using different antibodies and drug tolerance evaluation at high NAb level.

From their preliminary results, they conclude that the iLite® ADCC HER2 assay can be used for clinical applications to analyze patient samples and determine the presence of NAbs in clinical samples.

Download the poster

5 December 2019

Gene therapy is a treatment technique that uses genes to treat or prevent disease. It presents the possibility to alter the genes inside, or outside, a patient’s cells, in an effort to treat and ultimately eliminate the disease instead of treating symptoms and diseases as done with traditional drugs and surgery.

4 December 2019

Join us as we explore the future of Gene Therapy 

Svar Life Science is in a unique position to offer assistance in any Gene Therapy project. We have extensive experience and knowledge within the field of cell-based assays, immunogenicity and potency through our diagnostic and bioanalytical services. With robust technologies and platforms suited for all phases of drug development, we are the ideal partner when venturing into this new and exciting area. We develop products and offer services to address the obstacles and analytical challenges involved in Gene Therapy.

Bringing the benefits of the iLite® technology to Gene Therapy

The Svar iLite® cell-based platform has a long track record of high reproducibility and ease-of-use. Our assay-ready cells provide fast and high-quality, biologically relevant results for a wide range of targets.

Off-the-shelf cell-based reporter gene assays

  • AAV responsive cell lines ideal for detecting antibodies against the viral vector in human serum
  • Robust in vitro assay for the measurement of therapeutic product potency
  • Measuring immunogenicity effects of therapeutic gene treatment (capsid, DNA cargo and protein)

Testing Services

  • Immunogenicity assessments
  • Potency / Batch release testing

Custom Development

We can tailor projects specific to your needs, mechanism of action and target, developing a cell line that is ideally fit for purpose.

We can help you realize the promise of Gene Therapy!

Read more

25 September 2019

Now you can order from us on the go – send you order directly online

We are delighted to announce the launch of our new online product database and integrated product pages on our new website.

 

20 September 2019

Dear industry professionals, partners and friends of Svar Life Science, Wieslab and Calpro,

We are pleased to announce our participation at the following globally leading industry exhibitions for the fall of 2019!

Contact sales@svarlifescience.com today to learn more on our innovative, rapid and streamlined solutions for your drug development, clinical diagnosis and gene therapy projects!

Follow us on LinkedIn for updates on our exiting presentations and launches!

 

DSGH Årsmöte (Calpro)
AUGUST 30-31 - NYBORG

Nordic Life Science Days (Wieslab)
BOOTH 8 – SEPTEMBER 10-12 - MALMÖ

EMCHD (Svar Life Science)
European Meeting on Complement in Human Disease 
BOOTH 6 – SEPTEMBER 14-17 - MADRID

BEBPA (Svar Life Science)
BioPharmaceutical Emerging Best Practices Association
SEPTEMBER 25-27 – PRAGUE

Immunogenicity Bioassay Summit (Svar Life Science)
BOOTH 13 – OCTOBER 15-18 - WASHINGTON

Festival of Biologics (Svar Life Science)
BOOTH 61 – OCTOBER 15-17 - BASEL

UEG Week (Calpro)
United European Gastroenterology
BOOTH 24 – OCTOBER 20-23 - BARCELONA

Bioagora (Wieslab)
NOVEMBER 19 – COPENHAGEN

EBF (Wieslab)
European Bioanalysis Forum
NOVEMBER 20-22 - BARCELONA

IBD Nordic Conference (Calpro)
NOVEMBER 28-29 - MALMÖ

Czech and Slovak Gastroenterological Congress (Calpro)
NOVEMBER 27-28 - PRAGUE

 

5-4

 

2 September 2019

During the summer months (June, July, August) Wieslab will be open as usual

Opening hours for Wieslab Diagnostic Services during the Summer of 2019:
Midsummer, June 21st, 2019 – CLOSED

During the summer months (June, July, August) Wieslab will be open as usual, weekdays (Mon-Fri) 08:00-16:00 CEST (GMT+2 hours).

As we will have reduced workforce due to summer vacation (week 26-32), the reporting times during these period may be slightly longer than usual for certain analyses.

If it is very urgent to get a certain result, you are always welcome contact the laboratory staff directly on telephone +46 40 53 76 60.

Emergency testing

Acute testing (neurology) on suspicion of acute autoimmune encephalitis and/or acute paraneoplastic syndromes will be carried out during normal working hours when the laboratory is staffed, i.e. weekdays 08:00-16:00 CEST (GMT+2 hours).

Samples that arrive before 10 am will be analyzed the same day - see request form for more information.

Please call +46 40 53 76 60 to notify that acute samples for neurological symptoms are on the way to the Laboratory.

We wish you a great summer!

Wieslab AB

 

FOR MORE INFORMATION, PLEASE CONTACT:

Diagnostic.services@svarlifescience.com
Lab Manager, Rita Martins Olofsson: 040 - 643 44 12
Key Account Manager, Monica Blixt: 0708 - 86 28 10
Laboratory: 040 - 53 76 60

Click on the links for more information on:
Sampling instructions
Request Forms
Opening hours
Terms & Conditions

19 June 2019

iLite® IL-23 - offering significant benefits compared to conventional IL-23 assays

Targeting of IL-23 or the IL-23 receptor is a potential therapeutic approach for autoimmune diseases including psoriasis, inflammatory bowel disease, rheumatoid arthritis and multiple sclerosis.

IL-23 is a pro-inflammatory cytokine that shares traits with IL-12. Both cytokines contain the p40 subunit which binds to the receptor chain IL-12Rβ1. However, the two cytokines exert distinct non-redundant biological functions. Emerging data demonstrate that IL-23 is a key participant in central regulation of the cellular mechanisms involved in inflammation and therapeutic agents targeting both IL-23 and IL-12 cytokines are currently used to treat psoriasis and psoriatic arthritis. In addition, related agents are in clinical testing for a variety of inflammatory disorders.


The iLite® IL-23 Assay Ready Cells is derived from a highly specific reporter gene cell line that can discriminate on a subunit level between the sometime cross reactive IL-23 and IL-12 and subsequently be used for quantifying IL-23 activity, IL-23 inhibitor activity, e.g. Ustekinumab and the activity of neutralizing antibodies against the latter.

iLite® Cell-Based Assays
Valuable tools during the whole drug development continuum

iLite® cell lines can be developed for any biopharmaceutical target,  and assays for drug potency, i.e. drug activity, and neutralizing antibodies (NAbs) can easily be set-up using the same cell line. The iLite® technology eliminates many of the limitations of conventional cell-based assays as the cells are delivered as assay ready frozen cells, allowing cell-based assays to be carried out without the need for cell culture or the maintenance of cells continuously in the laboratory.

This allows for significant cost reductions and increases the applicability of cell-based assays to routine use as potency or neutralization assays.

For more information about our iLite® Assay Ready Cells - please click here.

3 April 2019

Colony-stimulating factors (CSF:s) activate and cause the cells to proliferate and differentiate into a specific kind of blood cell, usually white blood cells. There are different types of CSF:s and they have unique biological roles, indicating therapeutic benefits for a number of disease treatments ranging from different cancer forms, viral infections, and autoimmune diseases and as a result, many clinical trials targeting colony-stimulating factors are now well on their way.

Colony-stimulating factors (CSF:s) are secreted glycoproteins that bind to receptor proteins on the surfaces of hematopoietic stem cells, thereby activating intracellular signaling pathways that can cause the cells to proliferate and differentiate into a specific kind of blood cell, usually white blood cells. They play a part in the hosts´ response to injury and infection, and although they were originally defined as hematopoietic cell growth factors, CSF:s have been shown to have additional unique biological functions, suggesting that they could be used to target specific conditions. 

There is a great interest in targeting CSF:s in inflammatory and autoimmune disorders, as well as in cancer. Most CSF compounds of today are pharmaceutical analogs of CSF:s, where Filgrastim, a recombinant form of G-CSF, is the most well known. These therapies can be expensive and require cumbersome administration. New CSF analogues are represented primarily by biosimilars where the originator drug has gone off patent.

Click to learn more about the CSF family, their mechanism of actions, role as pharmaceutical targets and how the novel iLite® growth factor targets enable the study and targeting of human growth factor proteins and their receptors. 

Read more

1 March 2019

MALMÖ, Sweden– February 27, 2019

Following on from the successful launch of IL-2 and IL-6, two new interleukin cell lines, Svar Life Science now introduces another new cell line for use in the growth factor segment - iLite® Assay Ready Cells for G-CSF. 

Granulocyte Colony-Stimulating Factor (G-CSF) is a type of growth factor that impacts the treatment and survival of patients and is used after chemotherapy to help white blood cells recover after treatment or before and after a stem cell transplant.

Designed to be highly specific, with simple and quick protocols, the iLite G-CSF Assay Ready Cells offer a large signal to noise ratio, high matrix tolerance and have high reproducibility.

The world market for G-CSFs is growing rapidly and a major force is the development of G-CSF biosimilars - due to the expiry of existing patents there is considerable interest from many companies to enter the marketplace. A number of biosimilar compounds of traditional G-CSF drugs are in clinical development and the iLite® Platform offers cell-based assays that enable the study and targeting of human growth factor proteins and their receptors. With the advantage of a biologically relevant assay system offering functional and quantitative read-outs, the iLite cell-based assay enables broad usage in applications such as functional screening, functional characterization, QC lot release (potency) assays and neutralizing antibody studies.

The assays are designed as Assay Ready Cells, giving you instant access to your assay. These cell-based assays can also be set up by our in-house GLP and GCP compliant laboratory Wieslab, offering bioanalytical services within (PK/PD), immunogenicity (ADA/NAb) and potency.

“We are delighted to announce several new cell lines during 2019 within our key focus areas. These additions to our cell-based portfolio will support extensions of use for already established products and reflect our continuing investment in the iLite cell-based solution platform” says Therese Segerstein, Product Manager Cell-based Solutions.

Learn more about "Colony Stimulating Factors - their unique biological roles and therapeutic benefits" in our blog post.

View Product Launch Update 

27 February 2019

MALMÖ, Sweden,– February 18, 2019

Svar Life Science, today announced the launch new interleukin cell lines adding to the iLite® portfolio of call-based solutions. These two new products are designed to be highly specific, with simple and quick protocols, large signal to noise ratio, high matrix tolerance and have high reproducibility.

”We are strengthening the cell-based interleukin portfolio with the addition of the iLite® IL-2 and IL- 6. These cell lines broaden our offering within interleukin related disease areas, and they nicely complement our other assay solutions already appreciated by pharmaceutical clients” says Therese Segerstein, Product Manager Cell-based Solutions.

Interleukins have shown to have a pivotal role in the mediation of physiological response to infection and as they contribute significantly to the functional changes that accompany a particular disease or disorder, it has become evident that they represent a group of proteins with potential importance as therapeutic targets.

The iLite® Platform offers cell-based assays that enable the study and targeting of human interleukin proteins and their receptors, while addressing these issues. The assays are designed as Assay Ready Cells and the cell-based assays can also be set up by our in-house laboratory Wieslab offering bioanalytical services in compliance with GLP and GCP.

This enables their broad usage in applications such as functional screening, functional characterization, QC lot release (potency) assays and neutralizing antibody studies. 

“We are always ready to assist clients in accelerating their drug discovery and development programs in the most efficient way by supporting with unique reporter gene assays and tailored laboratory service solutions” adds Therese Segerstein.

 

Learn more about "Why are interleukins interesting targets in biological drug compounds" in our blog post.

View Product Launch Update 

18 February 2019

Interleukins have a pivotal role in the mediation of the physiological response to infection, immune response and contribute significantly to the functional changes that accompany a particular disease or a wide range of disorders. They are a group of naturally occurring proteins that mediate communication between cells and therefore have great potential as therapeutic targets. 

Several interleukins have already become successful treatment targets and many more are in early development or in different stages of clinical trials. These therapies are an increasingly important class of drugs in the treatment and management of many diseases and the main message is that interleukin therapeutics is a rapidly growing field with major pharmaceutical impact.

Click to learn more about the function and signaling of interleukins, potential therapeutic applications and the novel iLite® interleukin targets. 

Read more

 

14 February 2019

iLite® FGF21 Responsive Reporter Gene Cell Line With Improved Sensitivity

FGF21 holds promise to become a powerful drug in the treatment of a wide array of chronic human diseases, demonstrating that novel and potentially better medicines are within reach.

Fibroblast growth factor 21 (FGF21) is a hot target within the diabetes and obesity research and drug discovery. Known to function as an endocrine hormone with documented beneficial metabolic effects, FGF21 has been established as a viable, and excellent drug candidate molecule for therapeutic treatment of diabetes and cardiovascular disease associated with obesity.

The iLite® FGF21 Assay Ready Cells are genetically engineered reporter gene cells responsive to FGF21 by specific and proportional expression of Firefly Luciferase. As transmembrane protein β-Klotho has been identified as the necessary co-receptor able to permit FGF21 mediated activation of FGFRs in vitro and promote FGF21 action in vivo, the receptor chain FGFR1c in this new and improved cell line is overexpressed on the surface together with the co-factor β-Klotho which has been genetically optimized to enhance sensitivity.

FGF21 holds promise to eventually become a powerful drug in the treatment of a wide array of chronic human diseases, demonstrating that novel and potentially better medicines are within the reach.

iLite® Cell-Based Assays
Valuable tools during the whole drug development continuum

iLite® cell lines can be developed for any biopharmaceutical target,  and assays for drug potency, i.e. drug activity, and neutralizing antibodies (NAbs) can easily be set-up using the same cell line. The iLite® technology eliminates many of the limitations of conventional cell-based assays as the cells are delivered as assay ready frozen cells, allowing cell-based assays to be carried out without the need for cell culture or the maintenance of cells continuously in the laboratory.

This allows for significant cost reductions and increases the applicability of cell-based assays to routine use as potency or neutralization assays.

For more information about our iLite® Assay Ready Cells - please click here.

6 February 2019

We´re extending our complement portfolio

Our new activity marker, Complement TCC, is an excellent biomarker for complement studies in basic and translational research, clinical evaluation of treatment, safety studies of medical device and drugs.

Activity markers are used to determine whether deficiencies, overactivation or dysregulation in the complement system are causing, or contributing to, a person's disease or condition.

The Svar Complement activity markers give valuable intelligence in several situations where one might suspect that complement activation plays a role in the disorder. The Svar assays for complement activity markers are developed to target the unique neoepitopes only presented at the complement component or complex when activated.

Just like the Svar Complement C4d, launched in 2018, the Complement TCC is a flexible and easy to use enzyme immunoassay with ready to use reagents and short incubation times leading to reduced hands-on-time for the user.

TCC is suitable for all situations where determination of complement activity is wanted. Increased TCC levels can be detected in both acute injury (trauma, sepsis, myocardial infarction) and in chronic inflammation diseases  (SLE, RA, aHUS) and can be used successfully to rule out if a drug is toxic or if an adverse reaction is due to other related issues such as “infusion reactions”.

TCC is also well suited for studies of all medical devices in contact with blood, i.e. biological safety testing and part of the recommended tests for assessing complement activation according to ISO standard 10993-4 for hemocompatibility testing.

TCC is also well suited for studies of all medical devices in contact with blood, i.e. biological safety testing and part of the recommended tests for assessing complement activation according to ISO standard 10993-4 for hemocompatibility testing.

Benefits of Complement TCC:

  • A versatile marker with broad application area
  • Easy to Use for quick assessment
  • Reliable method with proven trackrecord
  • Help accelerate the drug development process
  • Improve patient safety

For more information about our activity markers - TCC and C4d - please click here.

28 January 2019