08.21.26 -- Navigating Extractables And Leachables Testing For 3D Single-Use Parts

Learn how containment strategy, process design, and early risk‑based decisions influence operator protection, compliance, and long‑term manufacturing success as potency levels continue to rise.

A proper test kit management program is no longer a “nice-to-have”—it’s a compliance necessity. Without a structured system, you risk inspector drift, failed audits, and errors in batch release.

Explore comprehensive analytics comparing MSC-EV quality attributes across tissue sources, donors, and scalable production platforms to identify critical manufacturing variables.

Modern lab equipment is essential to scientific research, but maintaining it is increasingly complex. Discover key challenges and strategies to futureproof your maintenance approach.

Gain insight into a whole-well fluorescence analysis that improves sensitivity and reproducibility in cell-based assays by accounting for uneven cell distribution.

ADC success depends on a continuous analytical strategy that connects early characterization to late-stage control, preventing variability, data gaps, and regulatory issues from compounding over time.

Advanced therapy production demands dedicated risk management. Align your facility monitoring framework with strict regulatory expectations for ATMP facility production.

As expectations for more physiologically relevant drug data rise, spheroids offer a practical path beyond 2D culture. Explore how to build reproducible 3D workflows and optimize key variables.

Immediate, quantifiable verification replaces seven-day incubation periods. Uncover how enzyme-based indicators optimize hydrogen peroxide decontamination.

A streamlined workflow enables confident mapping of lysine-linked conjugation sites in ADCs. See how integrated automation and high-resolution analysis simplify complex characterization challenges.

Monoclonal antibodies demand precise quality control. Modern molecular assays like qPCR deliver rapid impurity detection without compromising product integrity or compliance.

Hear from Dr. Fabio Luciani, Professor and Senior Researcher in Systems Immunology at the School of Medical Sciences and the Kirby Institute at UNSW Sydney about his recent research.

Simultaneous monitoring of over 30 bioprocess parameters in mammalian and microbial cultures stabilizes product quality while maximizing overall batch yields.

Transforming the pharma workforce requires strategic partnerships and a shift toward behavioral and operational readiness, moving beyond simple technical training to ensure performance and compliance.

Next-generation sequencing protocols streamline the identification of complex DNA rearrangements, bringing clarity and speed to gene-edited cell line characterization.

Selecting the right sample is vital for accurate HCP antibody coverage. Navigate the limitations of traditional methods and ensure your ELISA is truly fit for purpose.

Proactive compliance depends on automation. When asset data drives investigations, enforces change control, and reveals hidden failure patterns, compliance becomes an outcome of strong operations.

Achieving consistent 97% batch success requires unified quality management and proven regulatory expertise across clinical and commercial biologics manufacturing.

Creating a robust contamination control strategy is essential for pharmaceutical manufacturing. Learn to align risk management and technical controls to ensure lasting regulatory compliance.

This session highlights common late-stage risks and discusses how a stronger stability design can support confident IND, BLA, and long-term supply strategies.

EU GMP Annex 1 is driving meaningful changes in how teams behave inside cleanrooms. Understand what contamination awareness really means and how to build a culture where speaking up is standard.

For Indian biosimilar developers looking to capitalize on the upcoming patent cliff, it is vital to play to your strengths and identify strategies for breaking into competitive regulatory markets.