Interview with Lluïsa García, director-general of the spanish branch of KYMOS: “ with the support of CDTI Innovation and european funds MRR we lead the development of a technological platform to accelerate new treatments of gene therapy ”

In a context of increasing complexity and customization of treatments, the development of new medicines requires a high degree of technical expertise and regulatory rigour. That is why members, experts in the analysis and quality control has become essential for companies biofarmacéuticas. Founded for almost 25 years to respond to the growing need to outsource critical processes of I + D + i in the pharmaceutical sector, Kymos has been consolidated as one CRO (Contract Research Organization) is an international benchmark, specializing in comprehensive analytical services pharma, biotechnology and veterinarian.

The experience of its founders in the development of the anti-inflammatory Enantyum gave them a deep knowledge of the main demands of outsourcing in the pharmaceutical industry in the time. That marked a milestone in its position as a strategic partner in the sector. Since then, has expanded its to Key areas as organic products and biosimilares — monoclonal antibodies, recombinant proteins and vaccines — as well as the analytical development of innovative medicines, generic and veterinarians. All this in strict compliance with international standards of quality in europe (EMA) and the united states (FDA).

According to Lluïsa García, director-general of Kymos Spain: “ We Offer comprehensive analytical services covering all stages of development of a drug: since the initial investigation and characterization of active principles, through the design of analytical methods in the development of formulations, until bioanálisis in pre-stages and clinics. We also took the necessary studies to validate processes, ensuring stability and control the quality of medicines, etc. What differentiates us is to provide full analytical solutions adapted to each case. And, in addition, he adds: “ Our main mission is to accelerate the development of medicines, whether synthetic pharmaceuticals, biological, innovative, generic or biosimilares, through competitive services and high-quality, provided their own resources or in collaboration with centres of excellence ”.

Kymos laboratory, develop and validate analytical methods for advanced therapies

First analytical platform for adenoasociados virus in spain

In recent years, gene therapy has been consolidated as one of the major medical revolutions of the twenty-first century. This therapeutic strategy, to introduce genetic material in the cells of patients to correct mutations responsible for serious diseases, being allowed to move towards more effective treatments, customized and, in some cases even curative. However, the development of this kind of medicines is highly complex and requires specific tools to analyse its quality, safety and effectiveness of a rigorous.

In this context, Kymos, with the support of the CDTI and Innovation of european funds of the mechanism for the recovery and Resilience, is leading a pioneering project in Spain to create the first test technology platform for the characterization of virus adenoasociados (VPAS), one of the most used vector in gene therapy. Currently, the project is in an advanced stage, they are developed and qualified around 20 analytical methods, and the company has begun to spread awareness of the platform, at both national and international levels.

One of the pillars of the project is that analytic characterisation. “ The beijing platform for Kymos analyses some 20 viral vector attributes and components — the cápside proteica and transgén monocatenario dna techniques such as — by capillary electrophoresis, mass spectrometry, PCR (traditional and digital), essays phones, immunological, scan and sequence NGS. These tools are assured that the medicine include dna is right in the right dose and without impurities that endanger their safety or effectiveness ”, explains the director general of the spanish branch.

Although many of these therapies are directed at minority diseases — which means that clinical trials are conducted with few patients —, it was hoped that its use will be extended progressively most prevalent diseases. This represents an increase in the regulatory requirements, as has already happened with monoclonal antibodies. Hence the need for platforms to assess and validate these products with quality standards required by health authorities.

“ currently, there are few companies, and most outside spain, offering advanced analytical services policy and for these products ”, ensures García. “ This project we want to create a complete platform to provide quality control, optimize times and expedite patients' access to these therapies. This platform can be very beneficial for patients with rare genetic diseases or no treatment in two main ways ”, add.

Comprehensive Control of impurities

Another key aspect of the project is to detect impurities arising from the production process, which may pose a risk if not eliminated.

As the viral vectors generated within host cells, can be explosive phones or chemicals after purifying. “ it is crucial to eliminate completely all the residue, ” says García.

To that end, they are used techniques as a mass spectrometry and ELISA for residual proteins, quantitative PCR for dna, ELISA to enzymes as nucleasas, and conventional methods to detect additives such as antibiotics.

Collaboration público-privada high-level

This ambitious project is being developed in collaboration with the unit of production of Viral Vectors (UPV), belonging to VHIR, and in turn linked to the UAB. Collaboration público-privada is an essential pillar to combine scientific, technological and operational.

“ the UPV-UAB-VHIR — states García, with a strong record in the production and application of viral vectors, it has undertaken activities relating to the early stages of development, including the establishment of a universal cell test, and of serotype transgén of vpas, to assess its potency. For its part, Kymos, as a firm devoted to provide technological facilities, has dedicated its efforts in the development of methods that provide a direct and efficient transfer of technology to its clients ”.

According to the director-general, in addition, this platform will provide analytical support to organizations that develop génicas therapies, whether private companies, research centres or hospitals to carry out this kind of treatments internally.

International projection and positioning on personalized medicine

The development of this new technology platform not only is a step forward for Kymos, but also a strategic opportunity for the whole of spanish biomedical ecosystem. According To the director-general, its implementation will enable domestic enterprises to access specialized services without the need for international laboratories, saving time and resources. “ we believe that this platform will have a positive impact on the spanish biomedical ecosystem, which is already playing an important role in the area of advanced therapies, ” says.

In this context, the director general of the spanish branch stresses the role of Barcelona as one of the most dynamic poles of biomedical research in europe, with hospitals and centres of reference, both public and private.

For the coming years, the vision of the company is clear: to become an international modal also in the field of medicine and advanced therapies, as has already made in the field of biosimilares. “ it is between 5 and 10 years, we are relying on the biosimilares, also with the support of CDTI, and today we are working with large companies, mainly in asia. With génicas therapies anticipating a similar growth might not be as broad as that of biosimilares, but it will be exponentially. Kymos will be ready to accompany this growth from a position of leadership, "concludes García.

Outside of Kymos facilities

CDTI Innovation

The centre for technological development and innovation, CDTI E.P.E. is a public company under the ministry of Science, innovation and universities, whose goal is the promotion of technological innovation in business. The CDTI mission is to ensure that the business fabric english generates and transform knowledge into growth científico-técnico globally competitive, sustainable and inclusive. By 2024, within the framework of a new strategic plan, the CDTI provided more than $2.3 billion euros of support for business startups and spain.

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