Advanced Therapies

GLP and GMP-certified quality control and bioanalysis of nucleic acids, viral vectors, and lipid nanoparticles.

Services

All Advanced Therapies Services

Oligo testing

Bioanalysis of Nucleic Acids

Quantification of nucleic acids as therapeutics, biomarkers or similar with standardized and reproducible methods according to GLP.

Qtof Viral Vectors

Viral Vector Characterization

GMP-certified characterization and definition of quality attributes of Adeno-associated virus (AAV), Adenovirus (AV), and Lentivirus (LT).

Analytisches CRO HPLCs

Batch Testing and Batch Release

Our laboratories are GMP certified and we have a partial manufacturer authorization for Quality Control purposes.

Climatic chambers for stabilty studies

Stability Studies

Full ICH studies and on-going stability programmes at different storage conditions.

Pharmakokinetic Evaluation

Pharmacokinetic Evaluation & Statistics

Pharmacokinetic calculations and statistics of bioanalytical data from preclinical and clinical studies with Phoenix WinNonlin®.

BSL2 testing room

Cell-Based and Potency Assays

We offer GLP Cell-based neutralizing antibody assays for biologics and GMP Cell-based potency assays for vaccines and other biologics.

extractables and leachables

Extractables and Leachables

Semi-quantitative screening for both volatile, semi-volatile and non-volatile organic compounds.

Test tube in laboratory

Method Development, Validation and Transfer

Development and validation of analytical methods for excipients, APIs, intermediate products and finished products.

SphereFlash automatic colony counter

Microbiology

Laboratory including cleanroom with airlock technology and HEPA filters for testing of sterile and non-sterile APIs and drug products.

Histopathology

Histopathology Services

GLP-certified histopathology evaluation and consultancy services through our strategic partner Patconsult in order to complement our preclinical bioanalytical offer.

Ready to accelerate your drug development?
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Ask our experts

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Yong Suk Yang

Global QC Operation Team Manager

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We are currently developing multiple new biosimilar projects and consider Kymos one of the best CROs in Europe for drug release and testing

Dr. Dino Mangion

Head of Malta Operations

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We were positively impressed when Kymos reacted to our needs by investing in their stability capabilities, and now, two years down the line, with projects in full-swing, I can safely say that we made the right choice. In Kymos we have found a reliable, committed, trustworthy and professional partner.

Dr. Marius Strunk

Senior Pharmaceutical Development Manager

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Back in 2017 there weren’t many analytical CROs able to carry out Franz cell assays and Kymos’ pioneering work was pivotal for the registration of our product.

Dr. Pablo Avilés

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Kymos offered superior historical expertise by being exposed to so many different clients, pharmacological compounds, and therapeutic areas. They addressed and anticipated very diverse problems.

Jaime Algorta

Medical Affairs Director

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I have had a long and fruitful experience with Kymos and have a huge interest in their participation owing to their reliability.

OMEICOS THERAPEUTICS

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Prolytic is our analytical partner throughout the entire drug development process. Such a long and complex process requires a laboratory you can trust. Professional yet flexible, Prolytic accompanies us through the preclinical and clinical phases.

Dr. Meike Saul

Research Group Leader

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Establishing robust miRNA methods for valuable results is tricky. The team at Prolytic have been a key collaboration partner. With their 30 years of experience in bioanalytics and broad know-how in different techniques, study types, and substance groups, we were able to quickly develop a reproducible and reliable analysis method for miRNAs

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