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, (...)

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By |2024-07-08T10:18:09+02:00July 8th, 2024|Allgemein|Comments Off on Extractables & Leachables: Analysis, Study Design and ICH Q3E Guideline

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 (...)

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By |2024-05-31T11:20:00+02:00May 31st, 2024|Allgemein|Comments Off on Transdermal Testing: Analysis and Quality Control of Transdermal Patches

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 (...)

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By |2024-07-08T10:43:32+02:00April 5th, 2024|Allgemein|Comments Off on Stability Testing: What’s to come in 2024

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 (...)

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By |2024-04-17T11:24:56+02:00January 23rd, 2024|Allgemein|Comments Off on Impurity Profiling: Characterization of unknown impurities in pharmaceuticals

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 (...)

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By |2024-07-08T10:43:55+02:00November 21st, 2023|Allgemein|Comments Off on U-Shape and Lean Lab: Improving productivity in the laboratory

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 (...)

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By |2024-07-08T10:09:22+02:00September 14th, 2023|Allgemein|Comments Off on FDA New Guidance: NDSRIs Recommended Acceptable Intake Limits

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 (...)

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By |2024-01-03T08:52:38+01:00August 10th, 2023|Allgemein|Comments Off on VICH GL18 (R2): Changes in Residual Solvents for Veterinary Products

Diethylene Glycol and Ethylene Glycol 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 in May 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 (...)

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By |2024-07-08T10:09:55+02:00July 20th, 2023|Allgemein|Comments Off on Diethylene Glycol and Ethylene Glycol testing on high-risk drug components

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 (...)

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By |2024-07-08T10:10:45+02:00June 19th, 2023|Allgemein|Comments Off on Advanced Therapy Medicinal Products: First platform for adeno-associated viruses in gene therapy

ICH M10 Guideline: Bioanalytical Method Validation and Study Sample Analysis

ICH M10 is the new guide for the validation of bioanalytical methods which was adopted by ICH last year and has been implemented by EMA in January 2023. Our Bioanalysis department, working with the Quality Assurance Unit, has adapted their LC-MS/MS methods to the new guide, and starting from that date, their validation studies and (...)

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By |2024-07-08T10:11:17+02:00April 20th, 2023|Allgemein|Comments Off on ICH M10 Guideline: Bioanalytical Method Validation and Study Sample Analysis