09.10.26 -- FDA Issues New Guidance On Therapeutic Equivalence

Find out why it is critical that OEMs see and understand the benefits of taking time to build a mold or create automation more robustly to achieve long-term savings and higher annual production.

Bioprocess control relies on clear insight into cell health. Automated tracking cuts risk, saves time, boosts yield, and helps scale up fast to ensure smooth, top quality batch production runs daily.

Human intervention is the top contamination risk in ATMP manufacturing. Robotic gloveless isolators address that risk through full automation and real-time monitoring during aseptic filling.

Solid-form screening and PBPK modeling can accelerate timelines in early-phase drug development. Gain insight into formulation maps for ASDs and key criteria for salt screening.

Watch to discover transformative opportunities in the Life Sciences industry as well as explore trends and learn how to unify digital quality and manufacturing processes to stay ahead in this dynamic field.

Electrochemistry is helping pharma reduce hazardous materials, lower waste, and improve efficiency while building more sustainable production pathways.

Review the challenges and intricacies of effectively delivering drugs to the lung and the advantages of using nanoparticles and gentle particle processing techniques to enable delivery of sensitive drugs.

See how advances in capsule checkweighing technology enable more precise mass inspection, helping improve quality control, reduce variability, and meet increasingly stringent production requirements.

What does the BATH-O-CARD acronym represent, and how can it help you during your aqueous cleaning process?

EU GMP Annex 1 now defines clear expectations for glove integrity testing. Examine how reliability, efficiency, and equipment usability are becoming essential factors for maintaining compliance.

Outlined here are the benefits of PFS and how they relate to the delivery of drugs, how SARS-CoV-2 could be fueling an explosive increase in PFS demand, and how a partnership is the key to success.

Reliable drug delivery requires precision. Maintaining a robust seal throughout a product’s shelf life is essential to preserve sterility and ensure patient safety during self-administration.

Reveal how one pharmaceutical facility overcame strict cross-contamination rules and space limits without costly building modifications to ensure operational continuity.

Establish robust visual inspection rotations by separating planned dates from compliance expirations and using standardized templates to prevent scheduling bottlenecks.

Stay ahead of FDA QMSR, EU GMP, and AI regulations by adopting continuous audit readiness, ALCOA++ data integrity, and closed-loop workflows for global compliance.