04.11.25 -- Risk Management Planning: Be Prepared When Disaster Strikes

Navigating the inherent conflicts between GMP and biocontainment regulations is critical when designing specialized cleanrooms for advanced therapy manufacturing.

Dissect the reasons for capacity bottlenecks stemming from process development scope, downstream chromatography, and equipment constraints, and delve into the potential solutions associated with each.

Review a commercially-ready process capable of reproducing spray-dried dispersions with less manufacturing complexity and environmental impact, which out-designs and outperforms spray drying.

Listen to experts as they examine how the right combination of advanced technology and specialized expertise can leverage micronization to address the challenges often faced by small-molecule drugs.

Explore how laser-based headspace provides an alternative approach for detecting microbial contamination in sterile products, which allows for quicker, more accurate test results.

Discover how a vendor that offers integrated drug substance, drug product, and clinical testing activities under one organization facilitates improved communication and a more agile approach to development.

SMC experts discuss best practices and tips across a range of topics, which include program management, automation, and secondary services.

The pharmaceutical production of sterile powders presents unique hurdles. Examine the core principles and advanced techniques vital for aseptic filling, from containment to precise dosage control.

In the CCIT space, one single inspection technology cannot be used for every type of pharmaceutical product. You should always weigh the various factors to determine the ideal inspection methodology.

At Interphex, Todd and Todd interview Chuck Reed, VP of Weiler Engineering, to discuss blow-fill-seal packaging technology. Find out how the FDA is focused on patient safety.

Read about the transformative journey of a leading CDMO company and how they adopted an innovative platform to enhance data analytics and drive manufacturing advancements.

See how a study was designed to prove the suitability of ICR Swabs and lockable TSA w. LTHThio contact plates to detect low numbers of different bacterial test strains from Neoprene® gloves.

Uncover an integrated service package designed to simplify and accelerate the development pathway, even for APIs with challenging properties, such as low aqueous solubility and poor bioavailability.