Insights On Enterprise Solutions

31. Navigating Regulatory Expectations For Injectable Packaging 12/4/2025

    Explore insights on extractables, focusing on how they relate to the revised EU GMP Annex 1, new and evolved expectations under USP <382>, and the use of VHP decontamination in aseptic environments.

32. CDMO Media And Buffer Outsourcing: A Strategic Advantage 12/4/2025

    Learn how outsourcing cell culture media and buffers removes bottlenecks, freeing specialized CDMO resources. Ensure consistency, accelerate timelines, and streamline GMP readiness for client success.

33. Critical Path For Gene Therapy: AAV Analytical Lifecycle Considerations 12/2/2025

    Explore considerations for phase-appropriate AAV characterization and release activities from pre-clinical to late-phase products. Review validation challenges and paths for maturation of analytics.

34. Raising The Bar In Gene Therapy 12/1/2025

    Learn how a science-driven and digitally structured approach reduced onboarding timelines for gene therapy from 12 months to just 3, setting a new benchmark in technology transfers.

35. Framework To Deliver Standardized, Reliable Biomanufacturing Facilities 11/25/2025

    Standardized, continuously optimized facility design enables scalable, efficient, and reliable biomanufacturing that improves quality, accelerates timelines, and ensures consistent performance across sites.

36. Production Site Brno (CZ) Clinical/Commercial Syringe Line 11/24/2025

    Gain access to specialized sterile injectable manufacturing. Expertise covers vials and modern pre-filled syringe capacity, supported by single-use systems and decades of proven quality for global markets.

37. Controlled Nucleation Offers Homogeneity And Batch Consistency 11/24/2025

    Controlled nucleation standardizes freezing across all vials, leading to uniform ice crystals and improved lyo cake quality. This critical step reduces variability and supports robust product scale-up.

38. How To Choose The Right CDMO Partner For Fill & Finish 11/24/2025

    CDMO selection requires evaluating experience, quality standards, and flexibility. Assess technical transfer skills, supply chain security, and collaborative approach for a reliable, long-term project fit.

39. Flexible And Scalable Capacity That Grows With You 11/24/2025

    Explore flexible, globally compliant aseptic fill/finish services spanning clinical to commercial scales. Learn about handling various molecule types and dosage forms, supported by integrated development and regulatory services.

40. Human Performance In Pharma: Strengthening The Biotech Workforce 11/24/2025

    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.