As current events around COVID-19 continue to evolve, we're committed to contribute where we can. As a specialist laboratory and assay manufacturer, we are working hard to help address the urgent public health concerns by expanding the number of available COVID-19 antibody test possibilities.
In a recent press release, Sanofi and Regeneron Pharmaceuticals, Inc announce that they have initiated a clinical program evaluating Kevzara® (sarilumab) in patients suffering from severe COVID-19. This drug is a monoclonal antibody that inhibits interleukin 6 (IL-6) by blocking its receptor. Preliminary data suggests that IL-6 may play an important role in driving acute respiratory distress syndrome (ARDS) in critically ill COVID-19 patients.
To Our Customers & Business Partners,
The COVID-19 outbreak is a serious health situation and we extend our sympathies to people who have lost loved ones, to patients and healthcare professionals around the world.
As concern is growing in our communities, businesses, and the world at-large; we want to ensure you of our commitment and ability to serve your business.
Our focus has always been on delivering the solutions needed to provide answers in drug discovery and clinical diagnostics, and on the impact this has on human lives.
The complement system plays a key role in the immune defense against infection. In addition, it participates in the clearance of damaged cells and tissues and helps prevent cancer. However, uncontrolled complement activation may lead to life-threatening disorders, such as systemic inflammation and shock, dysregulation of coagulation/fibrinolysis, auto-aggression and under certain conditions tumorigenesis.
The complement system is an integral part of the innate immune response. Given its important role in many human disorders, complement activation measurements are important in a wide range of applications.
The individual complement profile of a patient gives valuable information of the course and severity of a disease, and as a consequence, complement assays have evolved as essential tools not only in initial diagnosis but for following disease progression and monitoring complement-targeted therapies.
To determine whether deficiencies, overactivation and/or dysregulation in the complement system are causing, or contributing to, a person's disease or condition activity biomarkers can be used, and these types of tools have become increasingly available in routine clinical use.
Complement is an essential part of innate immunity. Disturbances in the complement system can lead to infections, inflammation and amplification of disease. Testing the functionality and activity of complement are powerful diagnostic tools and can also be used to verify the effect of treatment.
Biosimilars have revolutionized the biopharmaceutical industry since they first appeared a little over a decade ago. They are medical products that are highly similar to an already approved reference product. In order for a biosimilar to be approved, the developer needs to demonstrate similarity to the reference product in key areas, such as pharmacokinetics, pharmacodynamics and evaluate efficacy, safety and immunogenicity in clinical studies.
We are pleased to inform that, on February 21st 2020, Wieslab successfully received ISO 15189 accreditation by Swedac, replacing the previous ISO17025 accreditation held for over 20 years.
Biosimilars are biological medical products that are highly similar to already approved innovator drugs. In biosimilar development, the main goal is not to show safety and efficacy, but rather to demonstrate similarity to the innovator product in key areas, such as pharmacokinetics, pharmacodynamics and evaluation of efficacy, safety and immunogenicity in clinical studies.
The FDA and its European counterpart, the EMA, as well as the World Health Organization have released guidelines on the development of biosimilars. All regulating bodies acknowledge the difficulties of biosimilar development. Each candidate drug has unique aspects that will require a case-by-case drug development program. For approval in the US, the biosimilar must be shown to be similar to the innovator product released on the US market and similarly, EU-approved biosimilars must be similar to their approved counterparts on the EU market. However, in order to facilitate global development programs, some foreign products are allowed in comparative clinical studies provided there is a scientific rationale of doing so.
A biosimilar is a biological medical product that is highly similar to an already approved “innovator” product. Unlike generics, which are identical copies of the approved product, biosimilars have small differences compared to the innovator product.
The first biosimilar was approved in the EU in 2006 and since then a wide range of biosimilars have reached market. The FDA and its European counterpart, the EMA, have released strict guidelines on the development of biosimilars. Somewhat surprisingly, the main goal of a biosimilar clinical development program is not to show safety and efficacy, but rather to demonstrate similarity to the innovator product in key areas, such as pharmacokinetics, pharmacodynamics and evaluation of efficacy, safety and immunogenicity in clinical studies.
We’re proud to present our collaboration with CORVOS – the pan European PhD program on Complement in opportunistic infections.
Gene therapy holds great promise as an effective treatment of many diseases that have a genetic basis. There are currently thousands of ongoing clinical trials within gene therapy and FDA-approved drugs are available on the market.
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.
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).
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.
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.
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 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
During Christmas, New Year - and Twelfth Night, Wieslab Diagnostic Services Laboratory is open as usual.
• December 20, 2019 from 08:00 to 16:00
• December 23, 08:00 to 14:00
• 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
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.
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.
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.
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.
We can tailor projects specific to your needs, mechanism of action and target, developing a cell line that is ideally fit for purpose.