White Papers

1. 8 Regulations Every Biotech & Pharma Quality Leader Must Know 9/14/2026

   Navigate essential biotech and pharma regulations safely. Learn how unifying global standards streamlines audits and accelerates development schedules.

2. The Life Sciences Guide To AI In Quality & Compliance 9/14/2026

   Implement AI in quality workflows without regulatory risk. Learn how strong governance and clear validation keep you audit-ready for compliance.

3. Reliability In Bioprocessing Is Your Competitive Advantage 9/11/2026

   Equipment reliability is a prerequisite for realizing value from digital transformation, automation, and data-driven initiatives in bioprocess manufacturing.

4. Precision In Miniature: Optimizing Multiparticulate Formulations For Pediatric Oncology 9/9/2026

   When an oral liquid formulation of crizotinib failed pediatric trials due to intolerable taste and irritation, a multiparticulate approach offered a technically demanding but viable path forward.

5. The Strategic Value Of In-House Delumping For Homogeneous API Production 9/9/2026

   API batch homogeneity supports efficient manufacturing. Controlled delumping improves powder flow and chargeability while maintaining particle size integrity and reducing GMP-scale risks.

6. Overcoming The Obstacles Of Spray-Dried Dispersion Scale-Up 9/9/2026

   SDD scale-up introduces scale-dependent risks that threaten bioavailability, stability, and manufacturability. This white paper details a model-based framework for managing those risks from early feasibility through commercial production.

7. Enhancing Quality And Environmental Monitoring Efficiency Through Paperless Sampling 9/9/2026

   At roughly 600,000 samples per year, manual EM documentation creates real compliance and operational risk. This whitepaper details how a fully integrated digital sampling system addresses both.

8. An Integrated Analytical Approach To Lipase Risk Management In Biologics Development 9/8/2026

   Conventional HCP testing cannot confirm whether residual lipases remain enzymatically active. Here, the authors examine why functional activity data are essential for managing polysorbate-related stability risk in biologics development.

9. Chemoenzymatic N-glycan Conjugation Of Native mAbs Provides Homogeneous, Efficacious ADCs 9/3/2026

   A chemoenzymatic two-stage protocol enables DAR2 ADCs from native, non-engineered mAbs via glycan remodeling at Asn-297 and copper-free click chemistry, with in vivo efficacy outperforming a comparable marketed ADC.

10. Bringing Novel ADC Formats Into The Clinic: AOC Process Development 9/3/2026

    Antibody-oligonucleotide conjugates introduce conjugation and purification challenges that standard ADC process development wasn't designed to solve. This white paper details practical approaches for each.