03.06.25 -- GDUFA And Facility Readiness: A New Era for Generic Drug Approvals

Physiologically based pharmacokinetic modeling is a powerful tool for clinical trial design that can be leveraged alongside early development experiments to reduce costs and accelerate timelines.

Life sciences startups must integrate compliance early to ensure regulatory approval and trust. Discover how prioritizing compliance streamlines processes and enables long-term success.

Watch media fill experts provide an overview of what to consider when selecting media for aseptic process simulations, particularly regarding regulatory requirements and user requirement specification.

Life science professionals hail from diverse backgrounds, educations, and work experiences. Explore how different mentorship models serve varied development needs and learning styles.

Find out why it is critical that OEMs see and understand the benefits of taking time to build a mold or create automation more robustly to achieve long-term savings and higher annual production.

Contamination Control Strategies (CCS) have long been a main concept, but advancing requirements and regulatory expectations create a challenge. Learn how to be effective and compliant with your CCS.

Examine the results of two, two-year studies that indicate good container closure integrity performance that can be achieved with stoppers of a given elastomer, independent of configuration.

Polyester amides (PEAs) bring several desired and differentiating properties to drug-eluting stent (DES) applications for treating coronary artery disease (CAD).

Discover how a Quality by Design approach can streamline the development of new sterile product filling lines, featuring a real-life example illustrating its effectiveness.

As APIs increase in potency and become more hazardous, delve into different containment methods and determine which would be most beneficial for your first (or next) containment device.

Unlock the potential of antibody-drug conjugates (ADCs) by exploring novel payloads, designed for easy access and evaluation, to accelerate your ADC drug development with proven efficacy and safety.

Digitalization has become crucial in the industry. Gain insight into how your manufacturing process can transition from paper to digital operations and aid in accelerating batch releases.