Now more than ever, immunology is a hot topic as we face the numerous challenges of the COVID19 pandemic. The world is patiently awaiting new therapies and vaccines to combat this disease in hopes of returning some sense of normalcy to our lives. 

KYMOS’ immunology expert, Dr. Carles Morte, shares his outlook on the future of promising new gene- and cell-based therapies and monoclonal antibodies developed against viral and other diseases. We talk to him about the technical evaluation required as the therapeutic target turns to the ever-so-complex immune system.

“In the years to come we will see the development of new biological therapies, where immunogenicity plays a major role. Our team has the expertise and extensive experience to face these new challenges”

Current challenges in monitoring and analysis of new pharmaceutical biologics and gene and cell therapies
The immune system is a highly complicated and extremely important part of our defense against disease. As such, there are several complexities to consider in the development of new gene and cell therapies.

  • Working with cellular systems or in vivo responses
  • Immune system imbalance through multiple triggers (from the drug itself and the vector)
  • Patient-specific pre-existing immunogenicity
  • Cellular (T cell-mediated) and innate responses

Carles leads a team with extensive immunology background in academia, the pharmaceutical industry and CROs. This expertise give them the unique know-how to overcome the most challenging technical projects using a range of analytical techniques such as ELISA, Electrochemiluminescence, Flow cytometry, ELISPOT or cell-based assays.

What differentiates Carles and his team from other CROs
Dr. Morte’s expert team has a depth of experience measuring the presence of antibodies and neutralizing antibodies against various drugs, from small peptides to large proteins, like toxins and hormones.

The team usually works on international projects requiring a high level of expertise, such as their work done on potency assays for biological drugs for multiple clients in China and South Korea. The department also works with cellular systems to determine the neutralizing effect of antibodies that requires the use of more complex analytical platforms:

“KYMOS can offer a full analysis of biologic drugs all centralized in our HQ lab; from physicochemical characterization to batch release into the market. Our flexibility and understanding of client’s needs are crucial to meet and exceed expectations”. 

How can we expect the global biologics market to evolve in the future?
In the wake of the COVID19 pandemic, people are more informed than ever on how the immune system works to protect against viruses and other diseases. We can expect to see even more medicines targeting the immune system, such us cytokine-neutralizing monoclonal antibodies to block viral effects, new vaccines as well as other biosimilar alternatives.

Diagnostic systems that measure immunogenicity and immune mediated reactions are essential and require developing, testing and validating that only highly specialized laboratories with a high level of expertise and experience, like KYMOS, can provide.

“This is not the last new infectious disease we will have to face, but together we can work toward effectively preparing for the next one”.

KYMOS is a GLP/GMP-certified, GCP-compliant, EMA and FDA-inspected European contract laboratory organization specializing in Bioanalysis of Large Molecules. Here you can view more information about KYMOS’ Bioanalysis and Immunogenicity of Biologics and Biosimilars and Cell-based services or contact us on commercial@kymos.com.