Industry Insights

51. Here's How USP mAb Standards Support Fast-Evolving Platform Approaches 5/24/2023

    Industry-accepted reference materials give drug manufacturers a competitive edge. Data shows that first-in-class mAbs hold a market lead over later entrants. This article discusses the benefits of using well-characterized reference materials instead of spending time and resources to develop them from scratch. 

52. Navigating The Road To Reality For Allogeneic Cell Therapies 11/9/2022

    Allogeneic cell therapies offer great clinical promise, but they also pose unique challenges. Here, we highlight tips to make the translational journey easier.

53. Vaccine Manufacturing: Harnessing Lab Deviations 9/8/2021

    For National Immunization Awareness Month, we're highlighting timely vaccine manufacturing-centric content such as this from Tunnell Consulting's Bob Johnson. The presence of deviations may seem inevitable, yet COVID has brought to light the question of how vaccine manufacturing sites can manufacture more vaccines, more efficiently. This article explains how.

54. The Upper Nasal Space: Drug Delivery's Next Frontier 11/9/2022

    Oral formulations of drugs account for up to 75% of prescriptions. However, many diseases require therapies to provide a maximal benefit as quickly as possible, and oral delivery may result in slow absorption. Enter drug delivery via the upper nasal space, which has the potential to provide a more rapid onset of activity, avoid degradation in the GI tract, and more benefits.

55. AI/ML In Drug Discovery & Development: Potential And Challenges 1/11/2023

    Selecting the wrong target molecule or focusing on the wrong area of investigation can cause major delays and waste valuable time and resources. Artificial intelligence (AI) and machine learning (ML) can help drug discovery researchers minimize these missteps in a few key ways.

56. Safe Handling Of Monoclonal Antibodies: Best Practices 3/7/2024

    Explore safety measures for handling mAbs in production in order to meet strict requirements that prevent contamination, product loss and exposure to cytotoxic agents or radioisotopes.

57. 5 Recommendations To Maximize CSV/CSA Outcomes 7/17/2024

    The computer system validation (CSV)/computer system assurance (CSA) process is correlated with other departments besides IT and quality. Accordingly, all stakeholders must think ahead and define what they need.

58. Supply Chain Resilience 4/9/2024

    Ensure a stable and reliable supply of essential medications for patients by proactively addressing pharmaceutical supply chain challenges and embracing innovative risk management strategies.

59. Remote Auditing Best Practices For GMP Compliance 3/25/2020

    Every organization that is regulated by the FDA has been adversely affected by the coronavirus (COVID-19) pandemic. This article will focus on remote auditing for good manufacturing practice (GMP) compliance, with a focus on the challenges, opportunities, and best practices for performing remote internal and external audits.

60. A Guide To Analytical Characterization Of Complex Molecular Formats 8/12/2025

    A thorough and adaptable analytical strategy is essential for navigating the complex mAb market. This approach boosts the likelihood of market approval and unlocks the full potential of these therapies.