About Carles Celma

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So far Carles Celma has created 31 blog entries.

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 (...)

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By |2024-02-21T14:58:42+01:00febrer 20th, 2024|Noticies|Comentaris tancats a Liraglutide & Semaglutide: Exploring Biosimilar Studies for GLP-1 receptor agonists

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 |2024-02-07T14:27:58+01:00gener 23rd, 2024|Noticies|Comentaris tancats a 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 |2024-01-03T08:46:49+01:00novembre 21st, 2023|Noticies|Comentaris tancats a 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 |2024-01-03T08:52:46+01:00setembre 14th, 2023|Noticies|Comentaris tancats a 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+01:00agost 10th, 2023|Noticies|Comentaris tancats a 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 |2024-01-03T08:52:29+01:00juliol 20th, 2023|Noticies|Comentaris tancats a 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 |2024-01-03T08:52:20+01:00juny 19th, 2023|Noticies|Comentaris tancats a Advanced Therapy Medicinal Products: First platform for adeno-associated viruses in gene therapy