09.12.25 -- FDA Report Details FY24 Inspections, Shows Big Uptick In Key Countries

Learn how EU GMP Annex 1 (2022) redefines cleanroom air monitoring standards and emphasizes continuous viable sampling in Grade A and B environments to ensure aseptic integrity and compliance.

Explore the regulatory and technical elements involved in changing biopharmaceutical manufacturing processes, particularly in regard to the use of different chromatography resins

PUPSIT and other integrity testing methods are crucial for manufacturers to reduce contamination risks and ensure drug product safety. Learn how your company can adhere to updated regulatory guidelines.

Explore core elements of the ISA-95 specification and how life sciences manufacturers can apply them within an integration solution designed for industrial data modeling, delivery, and governance.

Stringent QC release testing throughout biologic production, as mandated by health authorities, ensures product safety and quality through evaluations of identity, purity, potency, and critical quality attributes.

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.

Technological advancements are driving significant change in biomanufacturing. An industry expert highlights three pivotal areas: data science, advanced automation, and process analytical technologies.

Real-time viable particle monitoring instruments have been available for over a decade. Learn in detail about this technology and how it is used to detect viable particles in real time.

Find out how asset performance management boosts reliability, compliance, and efficiency in life sciences, which guides organizations from reactive fixes to predictive optimization.

The global market for injectable drugs will reach $69.13 billion by 2028. Examine the vital role of laminar airflow technology in meeting sterile integrity standards and minimizing contamination risks.

Explore how Process Analytical Technology accelerates novel conjugate development and how PAT is integrated with an ADC platform to enhance efficiency, data quality, and product consistency.

The industry faces rising R&D demands as many drug candidates fail in clinical trials. Explore cost-effective technologies that improve drug screening accuracy and accelerate successful drug development.

Discover the essentials of data integrity and its importance that helps empower organizations to uphold quality and regulatory standards confidently.

Unlock the power of blended operator training and learn how combining digital tools with hands-on instruction reduces errors, boosts retention, and empowers your workforce for real-world production success.

This study compares the accuracy, precision, and cost-effectiveness of three different analytical methods for quantifying recombinant human antibodies produced in a CHO cell line.

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

Learn more about issued guidelines on Critical Quality Attributes for IVT mRNA vaccines and biotherapeutics to focus on drug substance and LNP-encapsulated drug product assessment using an analyzer system.