All about Bioanalysis

ICH M10 Comparison with EMA and FDA Past Guidelines on Bioanalytical Method Validation

Although the ICH has published recommendations for the validation of analytical methods used in the evaluation of the quality of drugs and active substances (ICH Q2) for more than 25 years, it was not until recently (2022-2023) that we got a harmonized guideline that comprehends validation and analysis of drugs and analytes in biological matrices. (...)

By Carles Celma|2024-09-04T14:20:34+02:00September 4th, 2024|Bioanalysis|Comments Off

Transdermal Testing: Analysis and Quality Control of Transdermal Patches

Transdermal patches, or Transdermal Drug Delivery Systems (TDDS), are designed to deliver active substances through the skin directly into the bloodstream at a prolonged and constant rate. Due to their unique attributes, they present different challenges when controlling their quality, efficacy, and safety. In this article, we explore the mechanism in which they work, their (...)

By Carles Celma|2024-08-14T11:15:23+02:00May 31st, 2024|Bioanalysis, CMC|Comments Off

Liraglutide & Semaglutide: Exploring Biosimilar Studies for GLP-1 receptor agonists

Liraglutide and Semaglutide have become key players in the pharmaceutical and healthcare industry as they are both being used and have been approved not only as an anti-diabetic medication but also as an obesity and weight loss treatment. In combination with the huge growth of the biosimilar market in recent years and their patent expiry (...)

By Carles Celma|2024-08-14T10:52:27+02:00February 20th, 2024|Bioanalysis, CMC, Service|Comments Off

Advanced Therapy Medicinal Products: First platform for adeno-associated viruses in gene therapy

In a significant step towards enhancing the field of gene therapy, Kymos has joined forces with the VIRAL VECTOR PRODUCTION UNIT—a collaboration between the Autonomous University of Barcelona and the Vall d'Hebron Research Institute. Together, we are embarking on a project to study and develop a state-of-the-art technological platform for gene therapy assays, focusing specifically (...)

By Carles Celma|2024-08-14T10:31:57+02:00June 19th, 2023|Bioanalysis, CMC|Comments Off

One LC-MS/MS method for four Cannabinoids

Cannabis and its medicinal use have long been discussed among the medical community and have been repeatedly called for by patient associations. However, cannabis was illegal in many countries and classified as an abuse drug. In recent years, the perspective on cannabis has changed and in 2015 the FDA eased the regulatory requirements to allow (...)

By Carles Celma|2024-08-14T11:11:57+02:00February 9th, 2023|Bioanalysis|Comments Off

New FDA Draft Guideline for Oligonucleotide Therapeutics

In June 2022 the FDA published a draft version of a new guideline about “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics”. The guideline provides recommendations to assist the industry in the development of oligonucleotide therapeutics. This poses new challenges for oligonucleotide therapeutics developers and manufacturers. Maria Fauth, Department Manager Oligonucleotides at Kymos, explains (...)

By Carles Celma|2024-08-30T11:59:18+02:00October 28th, 2022|Bioanalysis, CMC|Comments Off

Bioequivalence studies in Europe

Bioequivalence studies are designed to show that two drugs are equivalent and substitutable. - But even though the medicines are replaceable, the providers of bioequivalence studies are not. Digna Tost, Department Manager of Bioanalysis of Small Molecules at Kymos, resumes why Kymos is the right partner for bioequivalence projects: "Our clients are looking for (...)

By Joan Puig de Dou|2024-08-14T10:39:03+02:00June 22nd, 2022|Bioanalysis|Comments Off

Quantifying Active Enzymes – A bioanalytical challenge

Lisa Hentschel, Master of Molecular Biosciences, started her career at Prolytic eight years ago as a technician in the ELISA team. Since 2017, she now leads the Biology Department and is a recognized expert in large molecule bioanalysis, ADA determination and enzyme activity measurement. Together with Dr Busch, COO at Eleva, she shares her (...)

By Carles Celma|2024-08-14T11:13:58+02:00February 22nd, 2022|Bioanalysis|Comments Off

Nucleic Acids: From Biological Underdog to Biotech Top Dog

The bioanalysis of nucleic acids, especially in biological matrices, is one of the newest services offered by the Kymos Group and carried out at its German subsidiary Prolytic. Maria Fauth, Head of the Oligonucleotides Department, has dedicated her entire academic and corporate career to the research and analysis of nucleic acids. She and Dr. (...)

By Joan Puig de Dou|2024-08-14T11:11:37+02:00February 3rd, 2022|Bioanalysis|Comments Off

Percutaneous Absorption: Like a Second Skin

An important function of the skin is to protect the body from the environment, and it is normally a very effective barrier against external substances. In some cases, however, penetration of active substances (API) into the skin is desired to provide a therapeutic effect. Hence, manufacturers of pharmaceutical topical products must test how well (...)

By Carles Celma|2024-08-30T11:58:00+02:00July 16th, 2021|Bioanalysis, Kymos Group|Comments Off

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