All about CMC - Kymos Group

Endotoxin Testing: A Complete Approach at Kymos Group

At Kymos Group, we continuously expand our analytical capabilities to support and match the needs of the pharmaceutical and biotech industries with state-of-the-art quality control solutions. Endotoxin testing is crucial when dealing with the safety of injectables, biologics, and medical devices, and we have updated our catalog of services to offer the full range (...)

By Sandra Magdaleno|2025-04-10T11:24:28+02:00April 10th, 2025|CMC, Service|Comments Off

Extractables & Leachables: Analysis, Study Design and ICH Q3E Guideline

When developing and releasing pharmaceutical products to the market, ensuring their safety and efficacy is of critical importance. Determining the impurity profile is a must, and a vital part of it is the analysis and assessment of the extractables and leachables (E&L) resulting from the interaction of the pharmaceutical products and the packaging (container-closure systems, (...)

By Carles Celma|2024-08-30T11:56:51+02:00July 8th, 2024|CMC|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

Stability Testing: What’s to come in 2024

Stability testing is an essential part of drug development as it ensures the efficacy and safety of the medicinal product throughout its shelf life. It allows the evaluation of APIs and drug product stability under the influence of various environmental factors that will enable us to determine their behavior and changes over time. Being such (...)

By Carles Celma|2024-08-14T11:14:38+02:00April 5th, 2024|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

Impurity Profiling: Characterization of unknown impurities in pharmaceuticals

Characterization of unknown impurities found in pharmaceutical substances and pharmaceutical products is a vital part of the regulatory approval process. According to ICH guidelines, if the estimation indicates an impurity content higher than 0.1%, it must be identified and characterized ensuring compliance with all regulatory requirements. This process is also known as impurity profiling. The (...)

By Carles Celma|2024-08-29T11:46:18+02:00January 23rd, 2024|CMC|Comments Off

U-Shape and Lean Lab: Improving productivity in the laboratory

The landscape of the life sciences ecosystem is ever-changing, and laboratory operations continually adapt to meet market demands, with efficiency and productivity crucial to the industry's evolution. Among the key drivers of this transformation are the adoption of methodologies like the Lean Lab principles and U-shape layout methodologies. These philosophies and strategies stand as vital (...)

By Carles Celma|2024-08-14T11:15:41+02:00November 21st, 2023|CMC, Kymos Group|Comments Off

FDA New Guidance: NDSRIs Recommended Acceptable Intake Limits

The US Food and Drug Administration (FDA) has taken a significant step to address the mutagenic and carcinogenic risk associated with Nitrosamine Drug Substance-Related Impurities (NDSRIs). This past August, the FDA introduced a final guidance framework that not only predicts the risks but also sets recommended acceptable intake (AI) limits for NDSRIs in drug products (...)

By Carles Celma|2024-08-14T10:46:23+02:00September 14th, 2023|CMC|Comments Off

VICH GL18 (R2): Changes in Residual Solvents for Veterinary Products

As stated by the EMA (European Medicines Agency), residual solvents are organic volatile chemicals used or produced during the manufacture of active substances or excipients, as well as in the preparation of veterinary medicinal products. These solvents are not completely removed by standard manufacturing techniques and can pose risks to the target animal and consumers (...)

By Carles Celma|2024-08-14T11:16:23+02:00August 10th, 2023|CMC|Comments Off

Diethylene Glycol (DEG) and Ethylene Glycol (EG) testing on high-risk drug components

Following several global incidents involving contaminated drug products specifically designed for children, the U.S. Food and Drug Administration (FDA) released a guidance document to address the potential danger of diethylene glycol (DEG) and ethylene glycol (EG) contamination in different pharmaceutical components. These incidents occurred across seven countries between 2022 and 2023 and have raised the (...)

By Carles Celma|2024-08-29T11:22:47+02:00July 20th, 2023|CMC, News|Comments Off