Lyophilized drug products, also known as freeze-dried pharmaceuticals, require specialized containers and administration devices to ensure their...
Over the past few decades, the scrutiny applied by EMEA and FDA regulators to extractables and leachables...
In this webinar, we will share the latest trends in feedback received from the FDA concerning extractables...
The practice of Organic Chromatographic Screening, aimed at discovering, identifying, and (semi-)quantifying organic compounds in extracts from...
Stability testing is an essential component of product development, conducted throughout the entire lifecycle of a biotherapeutic...
In response to the heightened focus on chemical characterization outlined in ISO 10993-1:2018, a significant revision of...
When selecting and qualifying the primary packaging for lyophilized drug products, an essential question arises: How comprehensive...
Ensuring the safety and efficacy of pharmaceutical products requires the accurate identification of organic extractables and leachables....
Ensuring the safety and efficacy of pharmaceutical products requires the accurate identification of organic extractables and leachables....
The world of physics is grounded in beautiful universal constants that seamlessly integrate into the equations governing...
Navigating Design Challenges, Sterilization Solutions, Lab Testing & Regulatory Compliance for Market Success
