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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.

• Writing An IND Module 3 For Cell And Gene Therapy Products

  This whitepaper outlines the critical considerations for CGT Investigational New Drug (IND) Module 3, as well as how to avoid clinical holds and ensure regulatory readiness.

• Keeping The Lights On With Wolfspeed SiC

  Introducing the “M” inverter, a modular, silicon carbide-based solution that optimizes utility-scale energy storage with higher efficiency, reliability, and scalability.

• 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.

• Multiple Fill Line Delivery Experience

  Learn how a multinational pharmaceutical company successfully implemented a global strategy for insulin cartridge filling, achieving seamless regulatory approval with zero deviations.

• Collaborative Variability Reduction In Cell Culture Media

  Variability reduction programs improve biomanufacturing by controlling raw‑material complexity, optimizing critical attributes, and boosting productivity through data‑driven partnerships.

• Membrane Adsorber Chromatography In Oligo-mAb Conjugation

  Discover how the team was able to expedite the conjugation of an oligonucleotide-monoclonal antibody (oligo-mAb) program leveraging experience in chromatography.

• Successful Cell-Based ADA Collaboration In mRNA Gene Replacement Therapy

  A biotech firm developed a rapid, sensitive, cell-based ADA assay through collaborative innovation, reducing variability and turnaround time while improving performance for mRNA gene therapy.

• 3-Week Database Builds That Withstood FDA Review

  Learn how a lean clinical team deployed global, regulator-ready databases in just three weeks to secure immediate Phase 3 entry and transform reproductive health research.

• MBR Solutions For Modern Industries

  This white paper will explore advanced, sustainable wastewater management systems that align with your business's growth trajectories and emergent needs. 

• 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.

• Scaling With The Client In Mind: A Customer-Centric Approach To Project Scale-Up

  In today’s fast-moving biopharma landscape, scaling from clinic to commercial takes more than expertise. See how collaboration can transform scale-up and drive confident progress