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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.

• Owen Mumford Slashes Audit Findings, CAPAs, And NCRs

  Gain insights into how Owen Mumford, a global medical device leader, enhanced their compliance and efficiency with software to reduce audit findings and improve quality management.

• Formulation Development Of Enterically Protected Spray Dried Dispersions

  Adrulipase spray-dried dispersions were evaluated to create an orally delivered, enteric-protected enzyme. The lead formulation provided the best acid protection, rapid release, and stability.

• ProPharma Supports A Contract Manufacturer's Form 483 Response

  Learn how a small contract manufacturer navigated a complex FDA 483 Observation notice and implemented effective remediation strategies that addressed multiple system-wide concerns.

• How Digitized Protocols Are Accelerating Clinical Research

  Digitized protocols, enhanced by artificial intelligence (AI), are transforming clinical trial operations by accelerating document generation, system integration, and trial optimization.

• A Review Of The Changing Trends And Use Of eCOA In Clinical Trials

  Delve into how electronic clinical outcome assessments are being transformed through new technologies, the maturation of digital organizations, and increased endorsement from regulatory bodies.

• 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.

• Development And Optimization Of Suspension-Adapted 293T Cell Line

  Learn how an adapted cell line can reduce costs and improve scalability in the production of lentiviral vectors for CGTs and examine its potential to produce GMP-grade lentiviral vectors.

• Biopharma In Non-Footprint Countries Gets Support

  Uncover how this tailored solution helped a multinational pharmaceutical and biotechnology firm to develop an in-country presence and expertise, which was critical to meeting their study timelines.

• Achieving Excellence In Clinical Research And Quality Management

  Lotus Clinical Research, founded in 2001, leverages regulatory expertise and digitalization to enhance quality, automate processes, and improve compliance in biopharmaceutical clinical trials.

• Overcoming HCP Co-Elution Issues Using Cell Line Engineering

  Product quality assessments revealed that a customer’s therapeutic protein had a range of hydrophobic HCPs. Review a solution that took an alternative approach by utilizing cell line engineering.

• The Effect Of Mixing Homogeneity In Retentate Vessel

  Discover a novel analytical method enhancing TFF diafiltration insights that deliver superior mixing, reliable scale-up, and breakthrough interpretation of diavolume performance.