03.07.24 -- Trends In FDA FY2023 Inspection-Based Warning Letters

It's essential to understand how scaling up affects your aseptic filling operations. Here are four topics to consider to help ensure your drug product will be taken care of and ready for production.

Experts discuss the best time to start thinking about patient centricity, the steps developers can take to achieve patient-centric drug design, and how formulation and dosage forms can make a difference.

Watch to gain a comprehensive understanding of water activity testing as well as how to effectively use nondestructive headspace analysis to generate dependable water activity data.

As demand for high-potency active pharmaceutical ingredients (HPAPIs) rises, ensuring your company utilizes specialized facilities with HPAPI handling capabilities is crucial.

The productivity of drug development has sharply declined over the past seven decades. Discover how improving preclinical models holds the key to solving the challenge at the heart of drug development.

Gain insight into the proper timeline for process validation, the importance of linking the user requirements specification (URS) to each step of validation to ensure complete compliance, and more.

Requirements to maintain a GxP environment mean researchers must conduct software validation on any updated software so that it continues to meet users’ needs.

Learn how you can simplify mixer selection for a particular capsule shell formulation by considering the formulation's viscosity and the appropriate level of shear.

See a quick visual summary of findings from an early feasibility clinical study featuring a 2-5 mL wearable injector with a viscous placebo.

Gain insights into how medical polyurethanes are enhancing medical devices, improving patient outcomes, and driving innovation in the healthcare industry.

Examine several important factors needed to effectively support oral solid dosage therapeutic manufacturing and overcome the complexities involved.

Single-use downstream applications including chromatography, filtration, and purification create difficult environments for supplier components due to the presence of chemicals across a wide pH range. 

Watch this webinar to hear about a collaboration that helped optimize their new filling line with single-use needles and reduced downtime.

When drug and API manufacturers decide to make the shift to bring production back to the U.S., they should be prepared with a well-designed quality system and a thorough tech transfer process.

Learn about three of the best methods for cleaning proteins, RNA, and DNA from laboratory equipment.

Explore an integrated service package designed to simplify and accelerate the development pathway, even for APIs with challenging properties such as low aqueous solubility and poor bioavailability.