07.18.25 -- FDA Quietly Eases Nitrosamine Reporting Rules Ahead Of August Deadline

Hear from a 21 CFR Part 11 expert with nearly 20 years of experience supporting pharmaceutical, diagnostic, and medical device companies with implementing solutions and systems to ensure compliance.

All future submissions are expected to align with FDA's draft guidance that clarifies the agency's expectations for establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements.

Single-use technology suppliers must align with advanced therapy manufacturers to de-risk manufacturing processes and chemical composition requirements to maintain the safety and efficacy of new treatments.

A facility monitoring system is a process monitoring tool that collects data from sensors such as optical particle counters, differential pressure sensors, and temperature probes in realtime.

Ensure the potency and efficacy of your biologic products with a GMP-compliant potency bioassay, offering accurate real-time assessments for GMP release and stability testing.

Ensure biopharmaceutical safety with a validated RT-dPCR workflow for mycoplasma detection. Learn how Mycoplasma Standard CFU Kits support compliance and robust contamination testing across diverse sample types.

Pre-use, post-sterilization integrity testing (PUPSIT) is vital for contamination control to ensure the integrity of sterilized equipment before use. Learn how PUPSIT can enhance safety and quality in your protocols.

Whether modifying existing instrumentation or building a new tool from the ground up, a meticulous process is as critical as the functional result.

With extensive experience in managing assay transfers across diverse sources and development stages, we have identified five critical factors that can significantly impact the success of potency assay transfers.

Discover how to enhance your pharmaceutical production efficiency with an intelligent MBR design that offers tailored software, handling systems, and inspection machines.

Discover new innovative solutions for mRNA analysis, enhancing accuracy and efficiency in IVT mRNA workflows, including advanced technologies and methodologies to optimize your research and development processes.

Evaluating quality attributes of therapeutic proteins requires a strategic, regulation-compliant selection of analytical techniques that consider molecular characteristics and phase to ensure characterization.

In uncertain times, digital validation ensures compliance, data integrity, and operational resilience. Discover how modern solutions streamline processes, reduce risk, and drive measurable ROI.

Discover how an innovative technology enhances LC-MS analysis of GLP-1 receptor agonists by minimizing peptide loss and improving assay sensitivity and consistency.

Discover an Isothermal Titration Calorimetry tool that is precise for characterizing molecular interactions, which is crucial for drug discovery and lead optimization in pharmaceutical research.

Explore a novel HPLC-UV/MS method for analyzing GLP-1 analogs to address critical challenges in peptide separation, impurity detection, and performance for improved reproducibility.

Watch this presentation to gain a comprehensive overview of how to evaluate Fc-mediated functions — and why doing so is vital to the success of biologic therapies.

Pharma leaders face rising pressure to deliver personalized therapies faster and more efficiently. Discover how top companies are evolving operations to stay agile, compliant, and competitive in a changing landscape.

Gain insight into how a global pharmaceutical company successfully transferred their cell therapy assays across international locations.

Explore how synthetic biology and a "scale-out" biomanufacturing strategy can unlock "infinite diversity in infinite combinations," optimizing MSC functionality for superior outcomes.

Examine the development steps that lead to an mRNA construct optimized for your requirements and that meets future-proof cGMP manufacturing requirements, thereby de-risking the development.

Review a survey that reveals key industry challenges such as labor shortages, skills gaps, and safety risks, while also spotlighting AI adoption and rising investment in quality innovation.