06.26.26 -- What To Do About Process Drift In Your Biosimilar's Reference Product

Advance potent drug manufacturing through tighter containment, thoughtful process engineering, and closed handling that protects workers while improving efficiency and scale.

This presentation explores the implications of the FDA Modernization Act 2.0, the significance of predictive validity in drug discovery, the efficacy of a human Liver-Chip, and more.

Digital PCR offers a precise, scalable approach to lentiviral vector characterization, enabling reliable genome titer, vector copy number, and RCL detection while reducing variability.

Transition from periodic sampling to continuous monitoring. Learn to establish risk-based alert limits and use N:M trending to maintain a true state of control in critical cleanroom zones.

New alternative phosphitylating reagents reduce the safety hazards associated with BCDP, enabling a safer and effective synthesis of key oligonucleotide sequences.

Read about how a global biopharmaceutical leader halved transcription errors and integrated over 350 instruments to accelerate the development of high-quality, clinically proven biosimilars.

Rheology connects formulation science to manufacturing reality. By tracking how drugs flow and respond to stress, teams can prevent batch variability and protect dosage performance.

Accurately identifying low‑level adapter dimers is key. Compare electrophoresis methods to show how different kits detect and resolve small fragments, helping researchers choose the best QC approach.

Active HEPA filtration protects cell cultures by restoring air quality within minutes. Delve into how continuous purification reduces contamination risks and ensures reliable, reproducible research.

Uncover the hurdles of APOE-targeted development and the precision tools—including target proteins and pre-formed fibrils—required to bridge the gap from risk identification to commercial success.

Discover how holistic training and validation services help manufacturers navigate complex regulatory demands and achieve operational readiness faster.

Achieving top performance in life sciences requires a continuous journey from Operational Readiness (OR) to sustained Operational Excellence (OE), ensuring safe startup and long-term efficiency.

Gain insight into critical lessons from FDA 483 observations and Warning Letters to proactively address common GMP cleanroom compliance failures and build an inspection-ready facility.

Find out how early identification of CQAs can streamline mRNA drug product development, reduce risk, and align with evolving regulatory expectations.

Observe how spatial profiling and advanced imaging tools are transforming drug discovery, featuring Wayne Stallaert’s lab’s work on cell cycle mapping and biomarker insights in cancer research.

Antibody-drug conjugates (ADCs) combine antibody targeting with potent cytotoxic payloads to treat resistant cancers, but their complexity requires phase-appropriate analytical strategies.

See how multi-parameter bioprocess analyzers support monitoring of 30+ bioprocess parameters across mammalian and microbial systems to optimize yield and product quality.

True validation requires documented proof that inspectors and methods consistently catch defects. Move beyond static SOPs to a state of continuous, data-backed compliance and audit readiness.

This overview outlines regulatory guidelines for sampling, examines the limitations of conventional methods, and emphasizes the advantages of aseptic, single-use approaches in achieving compliance.

Explore how to elevate Contamination Control Strategies from static documents to inspection-ready, lifecycle tools, as well as practical approaches to Annex 1 compliance and risk-based CCS development.

Demonstrating residual reagent clearance is a critical regulatory requirement in AAV manufacturing. Delve into how specialized assays and strategic partnerships streamline compliance.

ATMPs challenge existing E&L practices in single-use manufacturing. Gain expert insight into regulatory gaps, risk management needs, and the urgency for tailored approaches.