08.22.25 -- FDA Publishes 200+ CRLs For Increased Transparency

Here, we conduct a comprehensive analysis of diverse PROTAC (Proteolysis Targeting Chimeras) structures, evaluating their calculated physicochemical properties to identify key trends.

Effective small surface disinfection in cleanrooms requires adherence to detailed procedures and best practices. Learn about the critical steps, techniques, and validation needed to ensure product safety.

Choosing the right container closure system (CCS) format is crucial, so understanding the different parts involved, their functions, storage requirements, and how they impact administering the drug is essential.

Discover key strategies for contamination control in cleanrooms, as well as explore contaminant sources, behaviors, and best practices for cleaning and removal to ensure high standards of quality.

If you’re launching an international clinical trial, consider the noteworthy benefits of partnering with an in-country depot, including increased efficiency, reduced costs, and reliable access to raw materials.

Cleanroom systems are purposely designed to simplify the implementation of the aseptic manufacturing space that the industry needs to meet future sterile injectable capacity demand.

Unlock hidden cost savings in manufacturing. Find out how software-enabled manual visual inspection enhances efficiency, data integrity, and regulatory readiness without full automation's capital expense.

Unannounced FDA inspections are now the norm for foreign manufacturers. Read how this pivotal shift impacts global drug, biologic, and device companies and how to prepare.

Partnering with a leader in outsourced stability storage is revolutionizing the pharmaceutical and medical device industry by saving costs and resources, and ensuring product quality and compliance.

Overcome data integrity challenges in your bioanalytical lab. Uncover how a connected data strategy streamlines operations and enhances regulatory compliance.

Physiologically based pharmacokinetic (PBPK) modeling advancements are helping drug sponsors mitigate risk in preclinical and clinical studies through early identification of poor absorption properties.

To accelerate COVID-19 vaccine production, a leading biologics contract manufacturer sought high-speed labeling machines that could be rapidly deployed.