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WHITE PAPERS AND CASE STUDIES

• 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.

• Breaking Barriers In Malaria Prevention With A Mobile Cleanroom

  The delivery of this mobile cGMP cleanroom facility to ACT showcases Germfree’s commitment to providing innovative solutions that meet clients' unique needs and contribute to advancing healthcare.

• 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.

• Clear MRSA Infections At Single Low Doses

  Multidrug-resistant bacteria are rendering antibiotics ineffective. Review preclinical results of a potent macrocycle derivative and why collaboration is crucial to transition discoveries into treatments.

• Patented Process For Intermediates Useful For Etrasimod Arginine

  Explore how rethinking the synthetic strategy for Etrasimod can overcome the limitations of legacy routes, enabling more efficient chirality control, improved scalability, and more practical industrial API production.

• Closing The Gap In Our Understanding Of Sleep Health With DHTs

  What is the current state of sleep assessments in clinical trials, regulatory expectations, and what opportunities do wearable digital health technologies present?

• AAV-Based Gene Editing For Huntington's Disease

  LETI-101 uses AAV5 to deliver a compact CRISPR system for allele-selective editing of mutant HTT, showing promise as a one-time treatment for Huntington’s disease with strong preclinical safety and efficacy.

• Custom Microscope Objective Case Study

  Melles Griot custom objectives deliver superior imaging, color correction, and system repeatability—tailored for demanding applications where standard microscope optics fall short.

• Improvements In ADC Efficacy And Stability

  Antibody–drug conjugates link antibodies to potent toxins, but increased hydrophobicity impairs stability, manufacturing, and PK, spurring interest in hydrophilic linker strategies.

• 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.

• Physiologix™ Serum Replacement Performance On Mesenchymal Stem Cells

  Learn about the effectiveness of a xeno-free serum replacement in mesenchymal stem cell (MSC) culture and its potential to enhance cell growth and reduce variability compared to fetal bovine serum.

• 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.