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WHITE PAPERS AND CASE STUDIES

• How Early-Stage Planning Strategies Are Optimizing Drug Development

  Early integration of a target product profile (TPP) into early-stage planning is pivotal for steering drug development toward both regulatory success and commercial impact.

• 5 Steps To Design A Microbiological Performance Qualification For Facilities Explore five steps to design an EMPQ for sterile manufacturing: classification, protocol drafting, cleaning evaluation, disinfectant efficacy testing, and continuous improvement.
• UV Disinfection And Dechlorination At Cottonseed Processing Facility In Texas, US

  The Archer Daniels Midland Company (ADM) requires full-scale nonchemical disinfection and dechlorination treatment of RO feedwater to the boiler which supports their cottonseed processing facility in Lubbock, Texas.

• Pioneering Cancer Research Meets Unparalleled Veeva Vault Integration

  A biotech company revolutionizing cancer treatment faced delays due to a complex, error-prone document review process. Discover how integrating an innovative strategy transformed their workflow.

• Overcoming The Top 3 Challenges In Setting Up And Managing Clinical Trials

  Navigating the intricacies of clinical trials demands adept handling of document management, regulatory compliance, and financial forecasting. Learn key strategies for overcoming these hurdles.

• Reducing Complexity In Data Center Cooling Temperature Measurements

  Endress+Hauser’s iTHERM SurfaceLine TM611 non-invasive temperature measurement performs comparably to traditional industrial thermometers with an elegant mechanical innovation.

• 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.

• Performance Of A Customizable DMSO-Free Cryopreservation Media Formulation

  Cryopreservation enables cell therapy by storing cells long-term. A DMSO-free formula preserves cell viability and health, minimizing toxicities linked with traditional cryoprotectants.

• Next Generation Sequencing In Viral Safety Testing

  Next Generation Sequencing (NGS) offers a sensitive, high-throughput solution for detecting adventitious viral agents (AVAs), improving biopharmaceutical safety and accelerating regulatory-compliant product development.

• A Biosafety Cabinet For Virology Studies And Disease Surveillance

  Discover how Germfree tackled a unique challenge from the Public Health Agency of Canada by designing a custom Class III biosafety cabinet for advanced virology studies and disease surveillance.

• Optimizing Poloxamer 188

  Poloxamer 188 stabilizes proteins in liquid formulations and protects cells from shear stress. Molecular weight and hydrophobicity variations influence its effectiveness in different biopharmaceutical applications.

• Improving API Solubility

  Ensuring adequate solubility is crucial for small molecule drugs' effectiveness. Find out how poor solubility remains a significant challenge, potentially hindering medications from reaching the market.