12.04.25 -- Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots

Outdated quality systems delay product release. Discover how manufacturers can harness real-time data, operationalize QbD, and enhance compliance, efficiency, and supply chain continuity.

Regulators are increasingly favoring in vitro methods to prove bioequivalence, though differing guidelines and a new focus on matching reference product structures pose challenges.

Annex 1 sets EU regulatory standards for sterile manufacturing, which emphasize contamination control, quality management, and risk prevention to enhance patient safety and regulatory compliance globally.

Examine key strategies for reversed-phase isolation of biotherapeutic peptides, as well as learn about method development, scale-up techniques, and RP/MS analysis to enhance purification workflows.

Is your cleaning validation process truly aligned with current regulatory expectations? This checklist helps you implement a risk-based approach, focusing resources to effectively mitigate risk areas.

Sterility in injectable drug manufacturing is vital for patient safety. Read how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence.

The 2023 revision of EU GMP Annex 1 resets the global standard for sterile manufacturing. Learn what’s changed and how PIC/S alignment extends these requirements to many non-EU markets.

High shear mixers are essential tools for creating high-quality cannabis-infused products. Find out how they can be used in a variety of ways to create cannabis-infused products.

Focus on documentation quality, process consistency, and validation are required to transition from development to commercial scale, including capturing tacit knowledge and proactive risk management.

Explore headspace method development and validation for complex pharmaceutical systems, with insights into EU GMP Annex 1 compliance, container closure integrity, and ultracold transport validation.

As we look forward to the future of drug development, a panel comprising industry consultants and early development experts discussed examining new short- and long-term CDMO and supply chain strategies.

CDMOs are facing pressure to speed up their timelines and reduce costs. Consider the challenges facing developers and how integrated approaches can help advance molecules to IND.

Micronization is an incredibly important step in the process of transitioning a compound from initial discovery into the clinic. Uncover more about the key benefits of micronization.

The journey of a novel bioconjugate into clinic is complex and uncertain. Discover the particular challenges when moving a bioconjugate candidate from early development into clinic.

Teligent produces a range of generic prescription topical and injectable pharmaceuticals. To automate inspection on their high-throughput tube line, they turned to a dual-lane checkweigher.

See how a streamlined, EAD-based middle-down workflow can achieve consistent high sequence coverages of mAb subunits and confident PTM analysis in a single injection.

Understand more about a collaboration that has enabled BioIVT to enhance efficiency and responsiveness to its biopharmaceutical clients.