Svar Life Science

April 27, 2021

Assistance in development of new innovative therapies

With new technologies come new challenges in drug development - to ensure safety and efficacy of new drugs novel assays are needed

April 27, 2021

Assistance in development of new innovative therapies

With new technologies come new challenges in drug development - to ensure safety and efficacy of new drugs novel assays are needed

We are entering a new era in medicine where the “one drug fits all” of old is being replaced by custom-made personalized medicine and new ultra-sensitive non-invasive diagnostics. Instead of just treating the symptoms, advances in cell and molecular biology have yielded therapies that can be used to treat the root cause of the problem.  

In gene therapy, a functional copy of a gene can be introduced into the cells of the patient to compensate for a dysfunctional gene. Biological drugs based on monoclonal antibodies can be used to target specific molecules with great precision. New innovations within this field have led to a new generation of immune-based therapies, such as CAR-T cell therapy and bispecific antibody-based therapies. For these therapies, genetic engineering is used to improve the effectiveness of the drugs against some of the most devastating diseases. 

However, with these new technologies come new challenges in drug development. Novel assays are needed to ensure the safety and efficacy of these drugs. Find out how we at Svar Life Science can take on some of these challenges using our unique product and GLP, GCP and soon-to-be GMP compliant service portfolio. We will also address some of the improvements in diagnostic tools that allow non-invasive monitoring of biomarkers at previously non-detectable levels. 

Advance your drug discovery and development with cell-based potency assays

CASE STUDY: Learn how to design MOA reflective cell-based potency assays 
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How to Design Potency Assays for Gene Therapy Projects

In this downloadable case study, learn how Svar Life Sciences' iLite® cell-based reporter gene assays can help meet the analytical challenges of creating bioassays for gene therapy projects.

How can we at Svar Life Science assist in the development of these new innovative therapies? 

 

GENE THERAPY SOLUTIONS

What they are?

The principle of gene therapy is straightforward: deliver a functional gene to target cells in the patient to restore normal gene function. This is most commonly achieved using a recombinant Adeno-Associated Virus (AAV) vector where some of the viral genetic material has been replaced by a therapeutic cargo. Once the virus has infected the target cell, it uses the cell’s molecular machinery to produce the therapeutic protein. 

How can we help?
Svar Life Science combines robust analytical platforms with the knowledge and experience of our diagnostic and bioanalytical services, to meet the challenges of creating bioassays for gene therapy projects. We are working with major clients to create cell-based reporter-gene assays for immunogenicity and potency testing tailored to their projects. Upon completion, our bioanalytical services stand ready to provide further services adapted to the needs and requirements of the client.’s molecular machinery to produce the therapeutic protein. 

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CELL THERAPY CAR-T  THERAPEUTICS

What is it?   

Chimeric Antigen Receptor T-cell (CAR-T) therapy is a promising cancer immunotherapy in which a patient’s T-cells are genetically modified in the laboratory to recognize and destroy cancer cells. It has emerged as a promising therapy for the treatment of hematologic malignancies and additional tumor-associated antigens, such as PSMA, mesothelin, GD2, HER2, and epidermal growth factor receptors. 

How can we help?

We offer customer-specific cell-based iLite® reporter-gene assays for consistent and reliable quantification of T-cell activation. These assays reflect the Mechanism of Action (MoA) of therapies, such as CAR-T, that function by activating T-cells to recognize and destroy cancer cells.


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Join us as we explore the future of Gene Therapy

Join us as we explore the future of Gene Therapy

Watch the video to find out how the iLite® Technology can help move the promise of gene therapy to reality.

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BISPECIFIC & TRI-SPECIFIC ANTIBODIES 

What is it? 

Bispecific antibodies (bsAbs) are artificially engineered antibodies that can bind two different epitopes or antigens simultaneously. This property can be used to improve existing therapies or create entirely new therapeutic applications. For example, this technique can be used to create bsAbs that can bind both a tumor cell and a T-cell simultaneously, thereby directing the immune system to specific diseased target cells. Bispecific antibodies are also potential pharmaceuticals for the treatment of other diseases such as autoimmunity, bleeding disorders and infections.

Trispecific antibodies are similar to bsAbs but, as the name implies, can bind to three epitopes at once, further extending the usability of bsAbs.   

How can we help? 

We offer customer-specific cell-based iLite® reporter-gene assays for the quantification of T-cell activation. These assays reflect the Mechanism of Action (MoA) of therapies that function by activating T-cells to recognize and destroy target cells, and provide consistent and reliable measurement of potency of pathway activation for anti-CD3 bispecific antibodies.

Furthermore, we can design custom iLite® reporter-gene cell lines that are specific for the targets of trispecific drugs, where both targets can be monitored individually with a high level of sensitivity.

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SIMOA® TECHNOLOGY - DETECTING THE UNDETECTABLE IN RECORD TIME

What is it?
 
Single Molecular Array – Simoa® – Technology is an ultra-sensitive immunoassay technology that allows the detection of proteins and nucleic acids at the lowest possible levels. Being able to detect proteins and disease indicators at low levels, means that providers can be mindful of at-risk patients significantly earlier in their disease progression while also giving insights that are necessary to more precisely provide information and treatment options that can decrease the probability of future flares.  

Simoa® Technology has been used to detect early indicators of potential adverse cardiovascular outcomes for example and can be a vital tool in monitoring previously non-detectable protein biomarkers in serum for early cancer detection, as well as having great potential as a non-invasive platform for the monitoring of early stage cancer. 

How can we help? 
Wieslab Diagnostic Services was the first diagnostic laboratory in Scandinavia to offer NFL testing in blood and serum using the Simoa Technology. Measurement of NfL levels is of interest in disease activity, treatment response and prognosis in patients with neurodegenerative diseases. What makes NfL especially interesting is that it appears to be a general marker of neurological damage and is not disease specific. This means that NfL markers can be used in neurological disorders where no good markers exist today. Another advantage of using NfL is its flexibility, as it can be used as a biomarker for both disease state, prognosis and response to treatment.  

With the newest addition to our technology platform, the SIMOA HD-X Analyzer™, we are able to use a single molecule array digital ELISA to evaluate many markers of recent, ongoing, and future disease activity and tissue damage in patients.

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COMPLEMENT ACTIVATION  

What is it?   

As an essential part of the innate immune response, the complement pathway plays a vital role in the defense against pathogens. It is an indiscriminatory first response against any foreign structures in our body, and it is therefore not a surprise that since 2007 when the first Complement targeting drug was launched, numerous others have been marketed. An important field of development in new drug therapies, the Complement target has been linked to many different conditions and diseases across the range, and as more details are revealed about the pathway, new potential treatments are being discovered.  

 

How can we help? 

Svar has great knowledge and experience in Complement related assays through our Wieslab Complement assays, used for functional assessment of each “arm” of the pathway – each of the three activating pathways, as well as the terminal pathway. These assays as well known around the world, where a few of them do not have any competitor equivalents at all. In addition to this, we also have target specific assays for C4d and C5a, and many other and unique assays in our pipeline.  

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