03.21.25 -- Trends In FDA FY 2024 Inspection-Based Warning Letters

There's a need for continuous innovation to develop life-saving drugs and therapies. Explore the key outcomes of embracing Pharma 4.0 — and how they ladder up to drive critical business strategies.

A proactive approach to packaging development can ultimately ensure a smoother launch. Examine five key considerations when selecting components for your injectable drug product.

Gain insight into the role of vision inspection technologies in ensuring the quality of primary packaging in pharmaceutical manufacturing, common misconceptions when evaluating these systems, and more.

Discover how to reduce monoclonal antibody (mAb) manufacturing time and costs through process intensification as well as learn about continuous perfusion, ultrahigh cell density banks, and more.

Become equipped with the tools and strategies needed to strengthen your calibration efforts and better position your organization for success in regulatory audits.

To meet immediate vaccine demand, aseptic manufacturing capacity must increase quickly. This means environmental monitoring programs must adapt rapidly as well. Thoughtful planning can help.

Find out why testing for nitrosamines is essential in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and drug products to ensure safety and compliance.

The peptide manufacturing industry is evolving to meet the demands of efficiency, scalability, and sustainability. Uncover how the latest innovations are addressing these challenges.

Read about how softgels are poised to facilitate innovation in the pharmaceutical industry as well as ongoing advancements in optimizing drug bioavailability through nano formulations.

Watch the ways to design and de-risk molecules, streamlining the path to GMP manufacturing and clinical trials, and case studies that provide insight into key activities.

Phase-specific quality standards in biopharmaceuticals ensure GMP compliance, and maintain data integrity. See how experienced CDMOs help balance quality expectations.

Isolator technology can run continuously over several days, minimizing operator interaction and other opportunities to introduce contamination — ideal for high-volume, time-limited production runs.

Review how an integrated platform approach and innovative filtration strategies helped bring a novel therapeutic to Phase 1 clinical trials with reduced time and costs.

Single-use systems are critical to sustainable virus filtration. This checklist will guide you in selecting the right equipment and outline the best practices for implementation.