OP White Papers - random

31. Assessing A Targeted Molecular Method Against Traditional In Vitro Testing For Adventitious Virus Detection 10/3/2024

    Discover a CHO AOF panel that provides rapid detection of relevant adventitious viral contaminants in bulk harvest material, and explore data showing equivalent sensitivity to the in vitro assay.

32. White Paper: Nasal Delivery Of Spray Dried Biologics: Opportunities And Challenges 10/16/2024

    Explore the potential of spray-dried nasal formulations for biologics to achieve excellent stability and targeted delivery, paving the way for innovative and effective therapeutic solutions.

33. CHO Cell Lines For Recombinant Protein Production 6/2/2025

    Discover how new strategies in CHO cell line development are driving innovation and transforming the future of biologics manufacturing, from enhanced productivity to improved therapeutic quality.

34. Metabolite And Nutrient Analysis As Crucial Components For Optimal Upstream Process 2/8/2024

    Discover how insights into cell metabolism can further enable the development of efficient cell culture processes through tailored nutrient supplementation and monitoring.

35. White Paper: Spray Drying Biologics: An Alternative To Freeze Drying 10/16/2024

    Explore how innovative drying technologies can enhance the stability and efficacy of biologics, ensuring successful outcomes in this rapidly growing sector of the pharmaceutical industry.

36. The Key To Viral Vector Success 11/11/2024

    Establishing a robust and scalable viral vector process requires a multidisciplinary approach that incorporates expertise in foundational science, analytics, and biomanufacturing.

37. Vial Breakage During Lyophilization: Root Causes And Mitigation 10/16/2024

    Learn how controlling freezing rates, using specialized vials, and employing optimized stoppering techniques can reduce the risk of vial breakage during lyophilization and ensure high product quality.

38. Three-Dimensional Linkage Analysis With Digital PCR For Genome Integrity 2/14/2025

    A cost-effective approach with a comprehensive AAV analytical package holds the potential to advance the application of rAAV in cell and gene therapy for the treatment of human diseases.

39. Challenges And Solutions In Lyophilization Development For ADCs 12/10/2025

    Successful ADC lyophilization requires a robust, individualized process driven by thermal characterization using DSC and FDM to define the critical parameters for stability and efficient manufacturing.

40. Control Strategies And Method Development For Nitrosamines In APIs And Drug Products 4/15/2025

    Explore regulatory insights, analytical strategies, and real-world case studies for effective nitrosamine control in APIs and drug products.