Industry Insights

51. Closing The Loop: A Simple And Scalable Cell Processing Platform

    The transition from manual to automated cell processing is vital for therapeutic success. A versatile, single-use system simplifies operations, reduces variability, and ensures product quality throughout manufacturing.

52. Calculating The Right In-House/Outsource Mix For ADC Manufacturing 8/21/2025

    Antibody-drug conjugate innovators often question whether to outsource manufacturing activities or bring them in-house. Here are some key considerations.

53. Supply Chain Security: Focus On Raw Material Variability 3/26/2020

    Qualifying suppliers, increasing capacity, implementing a supplier scorecard, and surveying suppliers' number of production lines help guarantee supply, but close attention must be paid to raw materials.

54. Add Efficiency From Development To Validation With Design Of Experiments 3/10/2023

    A statistically-based design of experiments shortens development timelines while reducing product development and validation costs. This works by shrinking the total number of experiments required to evaluate parameters while strengthening analysis.

55. Are Single-Use Technologies Always The Answer? 1/9/2024

    It is clear that single-use technologies (SUTs) have won the war over reusable stainless steel. However, beneath the surface, there is a web of considerations that challenge the belief that SUTs are unequivocally cost-effective. Let's look at cost considerations as well as risk considerations.

56. Is The FDA About To Reclassify Your Drug Product As A Device? 9/27/2021

    Until Oct. 8, 2021, the FDA is seeking public comment on its plans to transition some drugs to device status. The agency's intended implementation will affect not only new products meeting both drug and device statutory definitions in connection with the approval process but also existing products on the market that may have been improperly classified as drugs.

57. Regulatory Considerations For First-Time Drug Developers 10/31/2024

    Navigate the challenging path from concept to clinical reality by partnering with an experienced CDMO that can provide the regulatory, clinical, and CMC expertise needed to move your therapeutic forward and bring it closer to patients in need.

58. Inline Buffer Dilution: An Agile System For Downstream Processes 3/15/2022

    This article will give an overview of the inline buffer dilution process and discuss its benefits compared to traditional formulation of buffer solutions.

59. 5 Strategic Advantages Of Manufacturing ADCs In-house 9/20/2024

    Outsourcing antibody-drug conjugate manufacturing is the status quo. This executive explains why her company chooses to do it themselves for reasons including quality control and cost management.

60. The Building Blocks Of A Robust Analytical Assay 8/1/2025

    Analytical assays aren't just important for quality control. Regulators expect them. These tips will help if you're just starting to build your analytical package.