CMC Analysis & Quality Control ·

GMP-certified and EMA & FDA inspected

Reliable solutions for CMC and quality control, delivered by GMP-certified and FDA & EMA & ANVISA inspected labs.

Services

All CMC Services & Quality Control Services

Bioequivalence studies

Quality Control of Biologics and Biosimilars

Complex characterization projects for innovative biologics and comparison of biosimilars.

Sample preparation MS

Quality Control of Small Molecules

Analytical tests for APIs, excipients, intermediate products, finished products, packaging materials and process environment samples.

Qtof Viral Vectors

Viral Vector Characterization

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

Test tube in laboratory

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.

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).

extractables and leachables

Extractables and Leachables

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

nitrosamines GC-MS

Elemental, Nitrosamines & Other Impurity Testing

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

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.

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.

image of dissolution test equipment for transdermal testing

Transdermal Testing

GMP and GLP-certified studies for transdermal patches during the whole life cycle of these products: from formulation and development to routine analysis.

PHARMAPROGRESS_Laboratory_OINPD_NGI_5-scaled

Orally Inhaled and Nasal Drug Products (Oindps) Testing

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

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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