All about Bioanalysis

New FDA Guideline for Oligonucleotide Therapeutics

In June 2024, the FDA published the final version of the guideline titled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics Guidance for Industry”. This document replaces the draft from 2022 and provides recommendations to assist the industry in the development of oligonucleotide therapeutics, but it also poses new challenges for developers and (...)

By Carles Celma|2024-11-29T13:17:54+01:00November 29th, 2024|Bioanalysis|Comments Off

New EMA Guideline on Topical Products: Impact on IVRT and IVPT

The European Medicines Agency (EMA) announced in October 2024 the adoption of the long-awaited guideline on the Quality and Equivalence of Topical Products. The final document was drafted back in 2018 and will be coming into effect in April 2025 with the official title “Guideline on quality and equivalence of locally applied, locally acting cutaneous (...)

By Carles Celma|2024-11-15T11:57:54+01:00November 15th, 2024|Bioanalysis|Comments Off

miRNA Analysis: From Fundamental Research to Product Innovation

The Nobel Prize in Medicine for 2024 brings long-awaited recognition to a once-overlooked molecule: microRNA, or miRNA. This year, the prize is awarded to scientists and researchers Victor Ambros and Gary Ruvkun for the discovery and characterization of microRNAs and their role in regulating gene expression. For decades, miRNA was dismissed as a “biological waste”, (...)

By Carles Celma|2024-10-15T12:25:49+02:00October 15th, 2024|Bioanalysis|Comments Off

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

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