04.15.25 -- Struggling With GxP Systems? There's A DAP For That

Container Closure Integrity Testing (CCIT) ensures drug sterility, evolving with regulatory updates like USP <1207>. Deterministic methods are preferred over probabilistic ones to maintain product integrity.

In Best Practices for Outsourcing Process Development, a panel of experts discussed four themes that may help drive the best outcomes when vetting process development service providers.

Explore aqueous detergent selection criteria as it fits into three broad categories: function and efficacy, health and safety, and environmental.

With increased pressure on CMC development to support shortened BLA submission timelines, mass spectrometry (MS) can be leveraged to accelerate and de-risk product and process development.

Review the implementation of a holistic Contamination Control Strategy (CCS). Discover four key considerations for assessing component readiness: product, process, protection, and proof.

Find solutions to five key challenges of quality assurance and information to help you identify which product inspection products can best support your application.

What if a formulation that removed the need for cold chain distribution was possible? Explore the formulation of vaccines and manufacturing considerations for dry powder inhaled vaccines.

Collaborating with an experienced CDMO can provide the expertise and facilities needed to navigate oral solid dose formulation complexities and ensure compliance with regulatory frameworks.

Uncover the challenges presented by the residues left behind by disinfectant solutions in cleanrooms as well as effective strategies for their management.

Learn how payloads and advanced payload intermediates can expedite drug development and elevate ADC therapies, and explore ADC payloads, payload intermediates, and solubility-enhancing technology.

Examine how Owen Mumford, a global medical device leader, enhanced their compliance and efficiency with software to reduce audit findings and improve quality management.

Providing personnel protection when working with highly potent active pharmaceutical ingredients is very tricky. See how a containment solution was designed for a benchtop vacuum oven process.

Gain deep insights and practical guidance for data by exploring how an industrial DataOps hub offers data contextualization and standardization, driven by evolving customer needs to leverage data models.