Document Migration

WHITE PAPERS AND CASE STUDIES

• Standardizing Content Management Across The Life Sciences Industry

  Explore a quality reference model that aims to foster further standardization within the life sciences industry, and discover the advantages of leveraging the standardized best practices within.

• Containment Solutions To Help Emerging Biologic Companies

  Set up your small company for long-term success using packaging containment offerings and services to help mitigate risks and speed up your time to market.

• Advancing Cell And Gene Therapy Clinical Development In 2023

  Examine considerations on bringing together the CMC and clinical teams early in the development process, promoting transparency and communication with regulators, and increasing patient access and diversity in clinical trials.

• Reducing Risk And Timelines In Cell Line Development

  Accelerate your biologic development by adopting faster, more reliable clone selection methods that reduce time and resources while improving the likelihood of identifying stable, high-producing cell lines.

• The GxP Digital Maturity Model

  Explore how the GMP Digital Maturity Model guides life sciences companies through five stages to improve compliance, efficiency, and profitability with strategic digital adoption.

• Optimizing Growth And Efficiency: The Impact Of Economic And Technological Trends On Businesses With Field Service Operations

  This white paper report presents the results of a survey conducted by Blumberg Advisory Group, a leading research and consulting firm to the Field Service Industry, analyzing the current economic and technological trends impacting businesses, with a specific focus on service businesses.

• Manufacturing Of Cytotoxic And Non-Cytotoxic Drugs In A Multiproduct Facility

  The experience and expertise of the CMO is crucial to avoid the risk of cross-contamination of the drug product, as failures or weaknesses in this process can pose risk to the end-user.

• Ensuring Reliability And Patient Safety With XiltriX

  Protect the integrity of your therapies and ensure patient safety by investing in reliable, real-time environmental monitoring systems that proactively address operational vulnerabilities.

• How To Adopt CSA For Streamlined Computer System Validation

  Discover how the FDA’s Computer Software Assurance guidance modernizes validation by reducing compliance burdens and fostering innovation through a streamlined approach to system validation.

• Vial Fogging: Practical Considerations For Vial Selection

  Vial fogging is a common phenomenon observed in lyophilized biologic drug products. This document presents two case studies that explore critical factors contributing to vial fogging and inform vial selection decisions.

• Catalent's Journey Of Continuous Improvement For CSV Excellence

  Learn how organizations must continuously reassess validation processes and digital tools to ensure compliance, enhance efficiency, and support global scalability amidst evolving regulatory expectations.

• CDMO Accelerates Contract Manufacturing With Electronic Batch Records

  A prominent CDMO sought a specialized software solution to streamline and accelerate its manufacturing processes, enabling the efficient production of complex, customized products in record time.