INSIGHTS ON QUALITY ASSURANCE

• Aiming For Success In Early mAb Process Development And Beyond

  Developing a monoclonal antibody (mAb) requires strict quality compliance. Building on a strong foundation from the start with a quality by design (QbD) approach is key for success and minimizing variability.

• Scientific Insights Into VHP Biodecontamination And BI Quality Management

  VHP biodecontamination ensures aseptic manufacturing, but BI variability challenges validation. Addressing rogue BIs and regulatory shifts strengthens contamination control and process reliability.

• Remote Measurements For Bulk Samples

  Remote Raman spectroscopy enables accurate material identification at long distances without complex focusing. Learn how pathlength, sample properties, and substrate choice impact signal quality.

• Accelerating Method Development And Manufacturing Of GLP-1 Analogs

  Explore a streamlined LC-UV/MS workflow that empowers labs to meet rising GLP-1 drug demand with faster, more informed decisions that enhance compliance and impurity detection efficiency.

• The Future Of Cleaning Validation

  7/23/2025

  Explore evolving cleaning validation strategies in life sciences, from regulatory foundations to digital innovations, and discover how agile, risk-based approaches can enhance compliance and efficiency.

• Biotech's Plastic Problem Meets Its Match

  8/8/2025

  Explore how a partnership with UW–Madison and Genentech developed a breakthrough recycling technology that is poised to reshape single-use bioprocessing sustainability.

• Ensuring AI Compliance In Life Sciences: 5 Critical Requirements

  7/24/2025

  Life sciences manufacturers face growing pressure to adopt AI while staying compliant. Discover five key areas to evaluate AI tools and how to simplify adoption with regulatory assurance.

• Cell And Gene Therapies: Insights For Faster Batch Release

  1/21/2026

  Cell and gene therapies are reshaping life sciences. Learn how quality can transition from a compliance role to a strategic partner, enabling innovation and growth during this transformative period.

• Aseptic Process Design And Simulation Under Annex 1 Guidelines

  1/9/2026

  Gain insight into how Annex 1 reshapes aseptic process validation, as well as into risk reduction by design and why isolators are redefining modern sterile manufacturing standards.