Automation

WHITE PAPERS AND CASE STUDIES

• Seizing Market Share Pre-Patent Expiry: The Evolution Of A CDMO Partnership In Navigating A Paragraph IV ANDA Submission

  The dynamic pharmaceutical landscape demands agility and strategic foresight. Explore how leveraging a key partnership helped to overcome a looming patent expiry for a second-generation acne medication.

• Enhancing Novel Developability Through Automated MS Analytics

  Growing biotherapeutic complexity demands MS workflows that can unify diverse datasets. Learn how automated approaches enhance data quality, streamline analysis, and support faster development.

• A Guide To Process Transparency In Custom Lab Automation Development

  Discover a practical guide to building custom automation systems with clarity and confidence, as well as how transparent processes reduce risk, prevent misalignment, and support reliable testing.

• Cell Line Development For Bispecific Antibodies

  See how the recently described cell line development paradigm shift, enabled by the Leap-In transposon platform, can extend to the development of bispecific monoclonal antibody-producing cell substrates.

• The City Of Fayetteville's Flood Resiliency In The Face Of Climate Change: Mapping 15 Watersheds

  The city of Fayetteville, North Carolina has always had flooding issues, but it’s been getting worse as weather patterns have been changing. They were hit four years in a row by storms Matthew (2016), Irma (2017), Florence (2018), and Dorian (2019). 

• A New Era Of ADC Development Demands A New Kind Of Partner

  Explore how to navigate the evolution of antibody-drug conjugates by mastering AI-driven selection, dose optimization, and new regulatory strategies for earlier-line clinical success.

• Flexible Fill/Finish Solutions To Bridge The Clinical-To-Commercial Gap

  As biopharma complexity grows, flexible CDMOs are essential for navigating evolving fill/finish needs, accelerated timelines, and regulatory uncertainty with agility and expertise.

• From Paper To Digital Study Management In Large Patient Registries

  Uncover how this sponsor was able to independently design and oversee its clinical study, minimizing external assistance, and easing the workload for their sites through mobile app accessibility.

• Contamination Control Of Particulate And Shuttle Blow-Fill-Seal Compliance

  Does shuttle blow-fill-seal truly meet Annex 1’s stricter contamination standards? New particle burden data challenges industry assumptions and reveals what manufacturers need to know.

• Preclinical Immuno-Oncology Models For CAR T-Cell Therapy Development

  The following preclinical IND-enabling oncology studies conducted by scientists at Aragen over the past 10 years highlight the role of robust preclinical models in advancing the fight against cancer.

• How To Get Products To Patients Faster With A Connected QMS

  BioBridge Global faced challenges with paper-heavy processes that risked errors and delays. Discover how digital solutions streamlined their operations and improved regulatory efficiency.

• The Complexities Of Effective Patient Retention In Clinical Trials

  Identifying and enrolling the right-fit patients from the outset is essential, but so is implementing comprehensive retention strategies that prioritize patient comfort, trust, and ongoing engagement.