Biologics and Biosimilars

Ensure regulatory compliance and faster time-to-market for your biologics with our bioanalysis and CMC solutions.

Biologics and biosimilars are transforming modern medicine, but their complex structures demand rigorous analytical and regulatory support. At Kymos, we specialize in tailored bioanalysis and CMC services for biologics and biosimilars, helping pharmaceutical and biotech companies navigate development and commercialization with speed, precision, and compliance.

Our experienced scientific teams and specialized facilities, operating under GMP and GLP compliance and successfully inspected by the EMA and FDA, deliver reliable results that keep your biologics programs moving forward.

Pharmaceutical Laboratory

Services

Our Biologics and Biosimilars Portfolio

Sample preparation biology bioanalytics

Bioanalysis of Biologics and Biosimilars

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

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.

Sample preparation MS

Determination of Enzyme Activity

Determination of active enzymes and enzymatic biomarkers in biological and formulation samples according to GLP.

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).

Climatic chambers for stabilty studies

Stability Studies

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

Qtof Viral Vectors

Viral Vector Characterization

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

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.

Analytisches CRO HPLCs

Batch Testing and Batch Release

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

Test tube in laboratory

Method Development, Validation and Transfer

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

Biomarker Analysis

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

Pharmakokinetic Evaluation

Pharmacokinetic Evaluation & Statistics

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

extractables and leachables

Extractables and Leachables

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

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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Orally Inhaled and Nasal Drug Products (Oindps) Testing

GMP-certified OINDPs testing for a broad range of delivery services including inhalers, nebulizers and nasal.

Histopathology

Histopathology Services

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

OUR EXPERIENCE

Biologics & Biosimilars we work with:

Our CMC & Quality Control, and Bioanalysis teams have experience with a wide range of biological drugs such as:

  • Monoclonal Antibodies (mAbs)
  • Therapeutic Proteins / Recombinant Proteins
  • Vaccines

  • Antibody Drug Conjugates (ADC)

  • Hormones and Trophic/Growth Factors
  • Enzymes

  • Heparins and Glycosaminoglycans

  • Biosimilars

Services

Our Biologics & Biosimilars Services Include:

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Preclinical & Clinical Studies:

  • Pharmacokinetic levels determination
  • Toxicokinetic determination
  • Efficacy and safety (pharmacodynamic determinations, metabolite identification, and biomarkers)
  • Immunogenicity (ADA & NAb)
  • Drug-drug interaction

CMC & Quality Control:

  • Physical-chemical parameters
  • Potency assays (bioassays)
  • Purity and aggregation
  • Impurities (related substances, residual solvents, nitrosamines, elemental impurities)
  • Protein interaction and protein binding
  • Characterization studies
  • Microbiological control (pathogen identification, sterility, endotoxins)
  • Stability studies
  • Comparability studies for biosimilars
  • Batch testing and batch release
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Team Discussion

Why partner with Kymos for your Biologics?

  • Regulatory Excellence:

    • FDA, EMA, and ANVISA inspected, GMP & GLP-certified, and GCP-compliant.

  • State-of-the-art equipment and techniques

    • Our laboratories are equipped with advanced platforms and instrumentation, and we employ a broad range of analytical techniques for complex biologics analysis.

  • Speed to Market:

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

  • Extensive Expertise:

    • Our multidisciplinary teams combine scientific know-how with deep regulatory understanding to guide your biologics and biosimilars through all stages of development.

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

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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