Innovate

Ensuring the safety and efficacy of active pharmaceutical ingredients (APIs) is of paramount importance. A critical aspect of this process involves the identification and mitigation of potentially mutagenic impurities, like nitrosamines. In this blog, we will explore the significance of risk mitigation at the early stages of API development and introduce a cutting-edge solution, Zeneth, […]

Did you know that organosilicon compounds have a multitude of benefits within the health care industry? They are often used in prosthetics and artificial joints, as coatings on syringes and hypodermic needles, and as materials for implantable medical devices such as pacemakers and insulin pumps. With a unique set of performance properties, such as being

At Lhasa, our commitment to fostering talent extends to the wider community. You may have read in our latest blog, Harnessing Purpose: The rise of Tech for Good, that Leeds is gaining recognition as the fastest growing tech hub in the UK. This was on full display at our Leeds Digital Festival 2023 event. The

Have you read our collaborative paper, published with the National Institute of Health Sciences (NIHS) of Japan? The paper is based on our shared project to improve in silico developmental and reproductive toxicity (DART) predictions, to safely move towards replacing traditional animal testing for chemical safety assessments. “The outcome of this collaborative and innovation project

Unreported changes to synthetic processes lead to the surprise presence of nitrosamine impurities in marketed drug products. This discovery resulted in the recall of several hypertension, heartburn, and diabetes medications. The nitrosamines crisis While many impurities are introduced directly as reagents, potentially mutagenic impurities (PMIs) arising during manufacture can be harder to identify as they

Traditional methods for evaluating the immunotoxic potential of pharmaceuticals typically involve animal testing, which is time-consuming, costly, and raises ethical concerns. In response to these challenges, regulatory agencies, including the Food and Drug Administration (FDA), are actively encouraging the development and acceptance of alternative methods. FDA’s new guidance on dermal sensitisation The FDA has recently

Veterinary medicines are commonly used by veterinarians, farmers and pet owners to treat and prevent animal diseases. Like what is already in place for pharmaceutical products within ICH M7, a guideline is also available for veterinary medicinal products to ensure appropriate control of mutagenic impurities. The guideline provides a practical framework that is applicable to