Cell and Gene Regulatory

31. Optimizing Syringe Performance For Reliable Drug Delivery 2/4/2026

    Reliable drug delivery requires precision. Maintaining a robust seal throughout a product’s shelf life is essential to preserve sterility and ensure patient safety during self-administration.

32. Maintaining Sterility Through Precise Component Design And Manufacture 2/4/2026

    Prioritizing high-quality component design and manufacturing excellence can mitigate risks, ensure long-term container closure integrity, and avoid the costly delays associated with non-compliance.

33. Extractables And Leachables: A Critical Part Of CCS Under EU GMP Annex 1 2/4/2026

    Managing chemical migration from packaging and process equipment is essential to protect patient safety, maintain drug stability, and ensure regulatory compliance.

34. FAQs On The Revised EU GMP Annex 1: Volume 7 2/4/2026

    Modernize your sterile manufacturing approach. Explore essential insights on contamination control strategies, risk management, and barrier technologies to ensure full regulatory alignment.

35. FAQs On The Revised EU GMP Annex 1: Volume 8 2/4/2026

    Successfully implementing a site-wide CCS requires prioritizing barrier technologies, integrating primary packaging into risk assessments, and adopting a data-driven approach to environmental monitoring.

36. Application Of A Dual Spiking Strategy In Viral Clearance Studies 2/3/2026

    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.

37. Engineering Reliability In Cell Therapy Manufacturing 2/3/2026

    A cell therapy manufacturing model built on precision planning, digital execution, lifecycle‑ready CMC systems, and transparent collaboration to achieve high reliability and reduce variability across programs.

38. A Year Of Separation: Which Advanced Modalities Are Built For Commercial Scale In 2026? 1/30/2026

    In 2026, advanced therapies diverge: winners pair proven biology with scalable manufacturing, delivery, and workflow fit, while others advance more slowly under operational and economic limits.

39. How Can Data Translation Challenges In CRO Partnerships Be Overcome? 1/29/2026

    Biopharma–CRO partnerships often struggle with fragmented communication. Gain insight into how streamlined, automated workflows improve transparency, data quality, and operational speed.

40. Enhancing Biopharma ROI With In-House Long-Read Sequencing 1/29/2026

    Long-read sequencing is redefining research by enabling clearer insights into complex genetic regions. Learn how this technology strengthens data confidence and accelerates modern R&D workflows.