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WHITE PAPERS AND CASE STUDIES

• 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.

• High-Quality Serum to Improve Performance And Supply Stability

  A consultative partnership brought valuable solutions to a global CDMO that was experiencing performance issues with their fetal bovine serum, and needed a new product source of superior quality fast.

• A Strategic Guide For Biotech And Biopharma Leaders

  Securing drug approval is a complex, high-stakes process, and outdated review workflows hinder progress. Explore modern solutions that accelerate timelines without compromising compliance or quality.

• Bringing Clinical Testing To New Heights In New Jersey

  Explore how clinical testing was transformed with a pioneering BSL-2 mobile laboratory on a Sprinter Van platform to enhance safety and portability for advanced biosafety requirements.

• AAV-Based Gene Editing For Huntington's Disease

  LETI-101 uses AAV5 to deliver a compact CRISPR system for allele-selective editing of mutant HTT, showing promise as a one-time treatment for Huntington’s disease with strong preclinical safety and efficacy.

• A Partnership To Deliver Excellence In Antibody Discovery And Production

  Explore the partnership that assisted FairJourney Biologics in methodically handling 30 to 40 different production projects concurrently.

• Expand Bandwidth With A Trusted Regulatory Writing Partner

  Find out how a mid-size biotech lacking the bandwidth, expertise, and resources to independently handle its regulatory writing requirements overcame this challenge.

• From Phase I In Australia To A Global Phase III

  With some help, see how one California-based biotech company was able to get its patients on treatment by the end of the fiscal year and identify additional opportunities to streamline processes and leverage document/process standards.

• Random And Semi-Targeted Integration In Cell Line Development

  While semi-targeted approaches may offer precision, uncover how they may fall short in overall efficiency and productivity, especially in late-stage manufacturing.

• AI Predictive Maintenance Prevents Batch Loss And Production Shutdown

  AI-powered predictive maintenance with wireless vibration sensors prevented costly batch loss and production shutdowns in pharma manufacturing by detecting and fixing equipment issues before failures occurred.

• Physiologix™ Serum Replacement Performance On Mesenchymal Stem Cells

  Learn about the effectiveness of a xeno-free serum replacement in mesenchymal stem cell (MSC) culture and its potential to enhance cell growth and reduce variability compared to fetal bovine serum.

• How To Unlock The Secret To Repeatable, Scalable Low Turnover

  Here, we explore the evolution of a 10-year partnership and extrapolate the principles that create cohesive teams and minimize turnover.