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WHITE PAPERS AND CASE STUDIES

• Progressing A Cystic Fibrosis Treatment With A Strong Culture Match

  Collaborate with an experienced CMO that combines transparency, expertise, and a shared commitment to help advance complex biologics from preclinical research to clinical success.

• Validation Provider Shortens The Path To Equipment Qualification

  Explore the partnership enabling Transcat to meet regulatory requirements while focusing on core R&D and accelerating the delivery of life-changing therapies.

• Leading Recruitment With A Strong Alzheimer's Referral Pool

  A strong referral network helped the Gainesville site rapidly recruit pTau217‑positive Alzheimer’s participants while upholding high data quality, boosting enrollment and outperforming other sites.

   

• RO Membranes' Protection At Pinghu Power Plant, China

  A power plant in Pinghu, Zhejiang Province in China needed to replace the use of chemical biocides and protect boiler feed make-up water from anaerobic and aerobic bacterial growth and associated biofouling.

• 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.

• Achieving Faster Timelines And Cost Savings Through Digital Validation

  Examine how the Project Ready program was leveraged to streamline validation processes for a CDMO, resulting in a 25% reduction in budget and faster project completion.

• Performance Of HEKima™ Adherent HEK Cell Medium

  Explore the performance of a serum-free medium designed for HEK-293 cells, comparing its efficacy to traditional media for protein expression and cell proliferation.

• Designing, Selecting, And Developing Bioconjugates For Clinical Success

  Accelerate the development of complex bioconjugates to unlock new possibilities for targeted therapies and advance the next generation of precision medicine.

• AMERICAN And Partners Install Boltless Restrained Underwater Pipeline System In Ashland, Wisconsin

  Beneath the waters of Chequamegon Bay on Lake Superior in Ashland, Wisconsin, about 4,500 feet of 24-inch AMERICAN Flex-Ring Ductile Iron Pipe and a submerged timber crib intake structure were installed to ensure the city’s residents have quality drinking water for the next 100 years. The Ashland Water Intake Project began May 1, 2025, and is now complete.

• 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.

• Transforming Development Through Mass Spectrometry Data Analysis

  Mass spectrometry is vital for understanding PTMs in modern biologics. Explore key challenges and how streamlined analysis can reveal deeper, more sensitive insights into biotherapeutic structure.

• 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.