Healthcare

WHITE PAPERS AND CASE STUDIES

• Digital Biomanufacturing, Now: From Digital Dreamer To Digital Doer

  Discover how digital biomanufacturing is revolutionizing drug production by exploring strategies for integrating digital technologies to enhance efficiency and innovation in bioprocessing workflows.

• Best Practices For Sterilization Validation In Medical Device Manufacturing

  Sterilization validation ensures medical device safety by confirming sterility through rigorous testing, method selection, and regulatory compliance, using both established and emerging sterilization technologies.

• Patient Diversity: Identifying Challenges, Opportunities, And Best Practices

  By listening to the voice of patient diversity and implementing FDA guidance measures, learn how stakeholders can improve trust, engagement, data reliability, patient outcomes, and promote public health.

• Democratize Batch Data Management For AAV Gene Therapies

  Explore a biotechnology company's process of choosing a data management solution that offered centralized batch data management, allowing the company to streamline its CMO data delivery process.

• Tackling Antimicrobial Resistance

  Learn how three companies collaborated to develop a new antibiotic to address the increasing development of antimicrobial resistance (AMR) that threatens the global health landscape.

• 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.

• Unveiling The Critical Role of Sleep In Clinical Studies

  Explore the critical role of sleep in clinical trials and its impact on health outcomes, emphasizing the need to address sleep disturbances for more effective and reliable research.

• Challenges In Developing Medical Devices From Animal-Based Biomaterials In China

  Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.

• MilliporeSigma's 97-Day Implementation Success Story

  Read how MilliporeSigma transformed validation processes with a digital validation system to achieve compliance in just 97 days, as well as learn key takeaways from their swift transition.

• 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.

• How A Pharma Company Improved Yield By 1.5% In Just Three Months

  A pharma company faced a 4% yield drop and variability at a manufacturing facility. Explore how they leveraged an AI-based platform to unify data, pinpoint inefficiencies, and enhance consistency in yields.

• If Data Integrity Matters, Paper Is Not An Option

  Ditch outdated paper assessments to ensure data integrity. Digital capture improves regulatory compliance, reduces administrative burden, and enhances the patient experience in clinical trials.