03.27.26 -- SUS Interchangeability Assessment And Qualification Best Practices

Explore the differences between liquid nitrogen and mechanical cryogenic freezers, as well as how each method supports scientific, medical, and industrial storage needs.

Discover key considerations for qualifying GMP raw materials in biologics manufacturing, emphasizing QC, supplier selection, and regulatory compliance to ensure therapeutic safety and efficacy.

Discover four common applications of cryopreservation and the science behind selecting the appropriate materials to build single-use solutions that enable cryogenic storage for cell and gene applications.

Drug manufacturers seek packaging that maintains integrity during processing and freezing, scales up to larger volumes easily, and remains robust throughout the temperature-controlled supply chain.

Examine the pivotal advancements in ADCs that focus on high-DAR, multispecific designs, and novel payloads, while addressing challenges in scalability, regulatory acceptance, and commercial viability.

Read about how engineered microbial hosts enable extracellular protein secretion, bypassing lysis to deliver cleaner starting material and faster recovery across multiple therapeutic modalities.

Learn how one family defied the odds — bringing a lifesaving gene therapy from idea to treatment in just 14 months after a devastating rare disease diagnosis.

Outdated quality systems delay product release.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

Potency assays for ATMPs demand precision. See how a matrix approach, regulatory alignment, and advanced technologies can overcome variability and ensure safety throughout the product lifecycle.

Understand more about the five key factors for advancing targeted in vivo LNP programs, from formulation and targeting strategies to bioanalytical readiness and scalability.

The ISABEL trap, which deploys interferometric scattering as a highly sensitive, fluorophore-label-free detection scheme, enables precise interpretation of the actions of complex biomolecular nanoparticles.

Review how AI can be safely and effectively deployed in regulated pharma environments, with practical guidance on risk, governance, and lifecycle management rooted in GAMP 5 principles.

Strategically optimize your upstream and downstream processes and decrease the timeline from optimization to commercial manufacturing.

Conversion of cellulose to bioethanol has huge potential to positively impact the global energy crisis, helping enable a shift away from fossil fuel dependency.

Gain insight into the key differences between traditional DOE and Functional DOE as Seongjin Kim demonstrates how the latter enhances bioprocess optimization through a fed-batch cell culture example.

Uncover how to determine the linear range for western blot quantification using total protein stains or housekeeping proteins to ensure accurate normalization and avoid saturation effects.