Biosimilar App Notes & Case Studies

31. Virus Retention Performance Under Diverse Processing Conditions 11/14/2025

    Virus filtration is robust across a wide range of process parameters, including high protein concentration and flow decay. Discover how retention relies on size exclusion to simplify risk assessment.

32. Non Animal Origin Squalene For High-Risk Applications 7/21/2025

    Explore an ethical and sustainable alternative to shark-derived squalene that is backed by robust data to deliver identical performance in vaccine formulations without environmental compromise.

33. Aseptic Filling Solution Enhances Sterility Assurance for Pharma Manufacturer 11/21/2024

    Emergent BioSolutions upgraded its Winnipeg site with the Cytiva SA25 aseptic filling workcell to improve sterility assurance, product flexibility, and regulatory compliance for CGT manufacturing.

34. Microbial Integrity Of Sampling Systems After Multiple Actuations 4/6/2026

    Repeated sampling doesn’t have to mean increased contamination risk. See how microbial ingress testing demonstrates sterility integrity after up to 50 sampling actuations.

35. Discover A System That Can Be Used With Various Cell Culture Media 6/19/2026

    Evolving CAR T cell therapies are raising the bar for manufacturing. Advances in cell expansion and the shift to serum-free media are redefining how scalable, future-ready processes are designed.

36. Enhanced Flow Kit Performance With Leak And PUPSIT Testing 1/13/2026

    Sterile drug filtration demands rigorous integrity testing to prevent contamination. Learn how PUPSIT and in situ leak testing strengthen compliance with EU GMP Annex 1 and ensure reliable manufacturing.

37. Evaluating Antibody Fragment Purification Using VH3 Resin 5/22/2026

    Explore how VH-domain targeting enables efficient purification of VH3 antibody fragments and bispecific formats, with strong recoveries and flexible wash conditions that support improved purity.

38. Microbial Recovery And Flow Performance With Membranes 2/25/2026

    Compare membrane materials and pore sizes to assess their impact on flow rate and microbial recovery. See how fast filtration and ≥90% organism recovery offer guidance for selecting reliable membranes.

39. CDMO Uses Robotic Gloveless Isolator For Advanced Therapeutics 4/28/2025

    CDMOs must innovate production architectures to meet the demands of advanced therapeutics to ensure a reliable supply and compliance. Discover how these approaches advance modern medicine and improve patient outcomes.

40. Optimized Product Recovery Using The Drug Product Filtration System 1/12/2026

    Explore strategies to maximize drug product recovery during sterile filtration, minimize hold-up volume, and reduce dilution after PUPSIT to ensure higher yield, improved efficiency, and less waste.