INSIGHTS ON SOLID DOSE MANUFACTURING

• Beyond Development: Using Continuous Manufacturing To Accelerate OSD Commercialization

  Hear firsthand insights from Douglas B. Hausner, Ph.D., Senior Manager of Continuous Manufacturing, on the company’s first OSD product submission enabled by continuous manufacturing and Real-Time Release Testing.

• Global Regulatory Harmonization: Comparisons In Aseptic Barrier Systems

  Compare global aseptic standards from the FDA, EMA, PIC/S, and WHO. Gain insights into how advanced barrier systems harmonize international requirements to ensure sterile product integrity and safety.

• Rheological Properties Of Pharmaceutical Excipients: Lactose Monohydrate And Carboxymethyl Cellulose

  Explore lactose monohydrate and CMC rheology, highlighting their flow, cohesion, and compressibility properties to optimize pharmaceutical formulations under varying stress and temperature conditions.

• How To Fast-Track Your Oral Solid Dose To Phase 1

  A strategic approach accelerates oral solid dose development by uniting molecular analysis, solubility improvement, formulation design, manufacturing efficiency, and stability testing to reach Phase 1 faster.

• Blister Solutions

  3/4/2025

  With over 6,000 tooling parts and an in-house machining center to ensure precision, explore this versatile blister service that provides both Thermoformed and Cold-Formed solutions.

• High Potency APIs And The Evolving Demands Of Drug Development

  4/13/2026

  See how higher API activity is changing expectations around containment, scalability, and cross‑functional alignment — and why early decisions now have a greater impact on long‑term success.

• How To Handle Intrinsic Product Powder Particles

  3/16/2026

  Powder filling creates intrinsic particles that interfere with continuous monitoring. Risk‑based strategies must separate product dust from true contamination to meet Annex 1 requirements.

• 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.

• Solubility And Improved Patient Outcomes

  9/9/2026

  Poor solubility poses major development challenges. Innovative formulation technologies and careful excipient selection can improve bioavailability and product performance.