White Papers

1. 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.

2. 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.

3. 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.

4. Digital CMC Maturity: Rethinking QTTP And Control Strategy 9/2/2026

   Digital CMC maturity depends on structured, science- and risk-based knowledge. Learn how connecting development, validation, regulatory, and lifecycle information can accelerate timelines.

5. Enhancing mAb Production: Advanced Downstream Purification Strategies 9/1/2026

   Explore how process optimization can address downstream mAb manufacturing bottlenecks, reduce labor and consumable costs, and support more efficient production without compromising performance.

6. Optimizing mAb Production: Upstream Process Intensification Strategies 9/1/2026

   See how integrated upstream and downstream intensification strategies can increase monoclonal antibody yield, streamline workflows, improve facility utilization, and reduce manufacturing costs.

7. Overview Of Hot Melt Extrusion And Its Pharmaceutical Applications 8/31/2026

   More than 40% of NCEs face aqueous solubility challenges. Here, we examine how hot melt extrusion addresses solubility, modified release, abuse deterrence, and scale-up across pharmaceutical development.

8. Robust Database Characterizes And Optimizes Product Development 8/29/2026

   Integrating material characterization data with process parameters accelerates drug development, reduces empirical testing, and strengthens regulatory compliance.

9. Determining The True Cost Of Single-Use Fluid Management 8/24/2026

   Looking beyond unit price reveals how reliability, leak prevention, and shelf life affect bioprocessing costs. Make purchasing decisions that support resilient and predictable operations.

10. SEDDS: Improving Oral Bioavailability Of Poorly Soluble Compounds 8/20/2026

    Nearly 90% of marketed drugs have poor water solubility. Learn how self-emulsifying drug delivery systems (SEDDS) resolve oral bioavailability failures across BCS Class II and IV compounds.