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WHITE PAPERS AND CASE STUDIES

• Robust, Scalable Strategy For Monodisperse Nanosuspensions Of Poorly Soluble Drugs

  By tailoring the formulation strategy, selecting the appropriate excipients, and fine-tuning process conditions, see how our team was able to improve bioavailability and in vivo exposure.

• Leveraging The Immunological Diversity Of The Pentamice® Platform For Covid-19 Antibody Discovery

  Consider this alternative immunization approach — the PentaMice platform, a collection of five wildtype mouse strains bred in-house for increased MHC class II diversity — and how we're leveraging it for COVID-19 antibody discovery.

• Modifying The Micro-Environment To Improve Dissolution Rate

  Discover how modifying the micro-environment with targeted excipients can significantly enhance the dissolution rate of poorly soluble drugs using conventional manufacturing methods.

• Richter BioLogics Drives Efficiency And Compliance With Unified Quality

  Learn how one CDMO tripled production, improved audit readiness, and built customer trust by unifying quality systems and embracing a digital-first approach.

• 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.

• Revolution In The EU Pharmaceutical Legislation Ahead

  Discover the impact revised pharmaceutical legislation will have on the industry by superseding regulations that have fostered the availability of safe and effective medicines for the past two decades.

• 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.

• Eliminate Clinical Trial White Space With The Right AI Strategy

  Learn how sponsors and CROs are using agentic AI to eliminate the unproductive time caused by manual, sequential processes and fragmented data systems.

• 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.

• Generation Of A Contamination Control Strategy

  An unaddressed compliance issue related to contamination control can pose a significant risk to a life sciences organization. This case study details a company's journey toward sustainable compliance.

• OEE And Product Inspection

  Explore the calculation of Overall Equipment Effectiveness (OEE) and the impact of product inspection equipment on OEE in the pharmaceutical industry.

• 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.