White Papers

31. 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.

32. Exploring The Need For Dose-Flexible Manufacturing 9/9/2026

    Regulatory pressure to study broader dose ranges is reshaping formulation strategy. This executive summary examines how early planning for dose flexibility reduces development risk and clinical delays.

33. 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.

34. Rational Design And Material-sparing Strategies For Enabled Intermediates And Drug Products 9/9/2026

    A material-sparing strategy integrating formulation mapping, lab-scale spray drying, and compact screening can accelerate risk identification and inform first-round tablet formulation decisions for poorly soluble APIs.

35. Navigating The Development Of Dry Powder For Inhalation 9/9/2026

    A CDMO-authored framework for navigating dry powder inhaler development, covering target product profile definition, API characterization, particle engineering technology selection, and encapsulation considerations.

36. 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.

37. 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.

38. 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.

39. 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.

40. 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.