TIDES: Oligonucleotides & Peptides

Accelerate your TIDES programs with our integrated CMC and bioanalytical solutions.

TIDES, encompassing therapeutic oligonucleotides and peptides, represent one of the most dynamic areas in modern drug development and require analytical strategies tailored to their structure and chemistry. At Kymos Group, we have practical experience working with GLP-1 peptides such as liraglutide and semaglutide, as well as with antisense oligonucleotides (ASOs) such as nusinersen.

At Kymos Group, we support peptide and oligonucleotide developers through every stage of the drug development cycle with GMP- and GLP-compliant services and our CMC and bioanalytical solutions. Our multidisciplinary teams combine decades of experience working with complex molecule types with regulatory compliance to accelerate your TIDES to market.

Pharmaceutical Laboratory

OUR EXPERIENCE

Oligos and Peptides we work with:

Our scientists have extensive experience developing and validating analytical methods for a broad spectrum of peptide and oligonucleotide-based drugs, including:

Peptides

  • Synthetic peptides

  • Peptidomimetics and conjugates

  • Peptide APIs and formulated products

Oligonucleotides

  • Antisense oligonucleotides (ASOs)
  • siRNA and miRNA
  • Aptamers
  • mRNA fragments and plasmid-derived oligos

Services

Our TIDES Services Include:

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Preclinical & Clinical Studies:

  • Quantification of peptides and oligonucleotides in biological matrices (LC-MS/MS, hybridization-based assays)
  • Pharmacokinetic and toxicokinetic studies
  • Biomarker analysis and metabolite identification
  • Immunogenicity (ADA & NAb) for conjugates and peptides

CMC & Quality Control:

  • Physico-chemical characterization (purity, identity, potency)
  • Sequence confirmation and structural analysis
  • Impurity profiling and degradation studies
  • Residual solvent and elemental impurity testing
  • Microbiological control (sterility, endotoxins, bioburden)
  • Stability studies under ICH conditions
  • Batch release and comparability testing
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Team Discussion

Why partner with Kymos for your TIDES?

  • Regulatory Excellence:

    • EMA and FDA-inspected laboratories operating under GMP, GLP, and GCP compliance ensure reliable data for global submissions.

  • State-of-the-art equipment and techniques

    • State-of-the-art LC-MS/MS, UHPLC, and oligo/peptide characterization technologies provide robust analytical solutions for complex TIDES.

  • Speed to Market:

    • We’re known for rapid turnaround times, helping you accelerate development timelines, crucial in the competitive TIDES landscape.

  • Extensive Expertise:

    • Our combined experience in small molecules, biologics, and advanced therapies uniquely positions us to handle hybrid modalities like TIDES with precision and scientific depth.

Services

Our TIDES Portfolio

Analytisches CRO HPLCs

Batch Testing and Batch Release

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

Capillary Electrophoresis Beckman PA800S

Biosimilar Comparability Studies

Testing lab for biosimilar products – GMP inspected by U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Bioequivalence studies

Quality Control of Biologics and Biosimilars

Complex characterization projects for innovative biologics and comparison of biosimilars.

Oligo testing

Bioanalysis of Nucleic Acids

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

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Method Development, Validation and Transfer

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

Climatic chambers for stabilty studies

Stability Studies

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

Sample preparation biology bioanalytics

Bioanalysis of Biologics and Biosimilars

Method development and validation and sample measurement of biologics and biosimilars.

Pharmakokinetic Evaluation

Pharmacokinetic Evaluation & Statistics

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

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.

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Extractables and Leachables

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

Biomarker Analysis

Biomarker analysis services across various therapeutic areas aided by our state-of-the-art equipment and multiplexing techniques.

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.

Ready to accelerate your drug development?
Let’s tailor the perfect solution for you!

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.

Samuel Salot

Chief Operating Officer

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Partnering with Kymos Group on our preclinical program for our first asset has been invaluable. Their team brought deep analytical expertise and ensured that biodistribution and histology assessments were conducted to the highest scientific and regulatory standards. Thanks to their responsiveness and commitment, we generated high-quality data that strengthened our preclinical package. We look forward to continuing our collaboration as we advance this innovative therapy into the clinic.

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.

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