White Papers

31. Best Practices In Commissioning And Qualification 7/5/2024

    An integrated approach to C&Q ensures coordination and synchronization between commissioning and qualification activities, enhancing both regulatory compliance and product safety.

32. Rapid, Seamless Upstream Process Development And Scale-Up For CHO-K1 Cells 6/28/2024

    Accelerate your biotech company's scale-up process while delivering consistent and strong cell growth, productivity, and product quality.

33. Mitigating Nitrosamine Risks In Pharmaceuticals 6/25/2024

    Nitrosamines can come from a range of sources, including raw materials, manufacturing processes, and even water sources. Detecting them requires sensitive analytical methods.

34. A New Framework For Identifying Nitrosamine Risks And Efficiently Derisking Products 6/18/2024

    Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.

35. 20 Years Of Biosimilars: Are We On The Right Track? 6/17/2024

    Explore the transformative journey of biosimilars, 20 years in. Through industry expert insights collected from a recent panel discussion, explore regulatory hurdles, market shifts, and the path ahead.

36. Microbial Challenge In-Use Studies 6/13/2024

    Learn more about how a partner with expertise can help you navigate the complex landscape of microbial challenge in-use studies and ensure the highest standards of patient care.

37. Revolutionizing Drug Discovery From "Undruggables" To AI 6/10/2024

    Explore four current trends in drug discovery, how each trend addresses some of the most crucial challenges in drug discovery, and the obstacles to their widespread adoption.

38. Considerations For Developing The Recirculation/Perfusion Process 6/6/2024

    Learn about the recirculation and perfusion processes made possible by single-use, fixed-bed bioreactors designed for scaling up adherent cell culture processes.

39. A Checklist For Efficient And Reliable Gene Therapy Manufacturing 6/3/2024

    Gain insight into how to design and execute an efficient upstream AAV production process, and follow the checklist within to ensure all appropriate factors are considered at each phase of drug development.

40. Optimizing Aliquoting For Robust Cell And Gene Therapy Processes 6/3/2024

    Explore the challenges of liquid handling in cell and gene therapy processes as well as innovative solutions to simplify aliquoting in modern bioprocesses.