07.10.26 -- Essential CMC Elements For A Therapeutic Secretome

Through case studies and practical insights spanning complex drug substance and drug products like ADCs, learn more about navigating complexities with integrated regulatory services.

Global recalls demand more than fast action. See how differing requirements, documentation standards, and timelines shape recall outcomes, and why preparedness is critical to avoiding regulatory risk.

Explore how an alternative spiking strategy can streamline viral clearance studies, reduce material demands, and maintain compliance while addressing the challenges posed by MLV and MMV.

Discover how AI is revolutionizing biotech manufacturing as Toni and Christian reveal the story, strategy, and regulatory impact behind their innovative AI model validation cheat sheet.

In this presentation, Dr. Nigel Jackson, Principal Engineer in R&D, offers an in-depth discussion on regulatory guidance and recent updates pertaining to virus filtration.

True Annex 1 compliance requires a facility-wide contamination-control culture. Find out how rigorous risk awareness shapes behavior at every touchpoint across a manufacturing environment.

Tracking rare immune cells is no longer limited by conventional flow cytometry sensitivity. Uncover how integrated pre‑enrichment strategies enable reliable detection and improved quantification.

Microbial survival during gas decompression is a proven risk. Learn why point-of-use monitoring is essential for Annex 1 compliance and how to ensure process gas purity in sterile environments.

Examine single-vesicle profiling methods that reveal tissue-specific surface marker expression patterns invisible to bulk EV analysis, with molecular-level resolution across three MSC sources.

ADCs require integrated, early-stage analytics to manage complex interactions among components, enabling better characterization, reduced development risk, and faster, more reliable progression.

Gain insight into a connected approach to pharmaceutical development that links R&D, manufacturing, and supply chain operations to improve visibility, speed, and quality.

Observe a modern approach to adventitious virus detection that shows how targeted sequencing can achieve sensitive, comprehensive viral safety testing aligned with ICH MAP, RAP, and HAP expectations.

Paper-based records still shape many life sciences operations, but they bring hidden risks. Delve into how manual documentation impacts accuracy, efficiency, and compliance.

Different extraction methods produce dramatically different DNA sizes and qualities, directly affecting long‑read sequencing results. See how performing early QC can improve sequencing success.

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.

AI and MES can’t meet pharma’s visual inspection demands. Discover how purpose-built software ensures defect detection, compliance, and paperless quality for safer, more efficient operations.

In AAV manufacturing, long-term success depends not just on titers, but on maximizing the percentage of full capsids to ensure efficacy, safety, and scalability.

GMP compliance requires monitoring microbial contamination levels in cleanrooms and clean spaces. It is important to know the role active air samplers play in this process and parameters for evaluating them.