Poorly Soluble Drug Formulation: When to Use Hot-Melt Extrusion vs Spray Drying
Enhancing oral bioavailability for BCS Class II and IV molecules requires converting crystalline active ingredients into amorphous solid dispersions. This technical guide explores decision criteria for Poorly Soluble Drug Formulation campaigns. Discover how biopharma sponsors evaluate thermal stability, polymer carriers, organic solvent solubility, and scale-up parameters for HME and Spray Drying.
Sterile Barrier Packaging Validation for Medical Devices: Common Testing Gaps
Protecting terminally sterilized medical devices requires uncompromising packaging integrity across complex supply chains. This technical guide identifies critical compliance gaps in Sterile Barrier Packaging Validation. Discover how medical device manufacturers execute ISO 11607 protocols, heat sealing parameter challenges, ASTM D4169 transit simulations, and microbial leak testing.
Latest Articles
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Biologics
Protein A Resin Cost and Reuse: How CDMOs Manage Purification Economics in mAb Manufacturing
August 4, 2026Biosimilar CMC Gap Analysis: What Sponsors Should Review Before Choosing a CDMO
July 29, 2026Glycosylation Control in Biologics Manufacturing: Why Sponsors Must Audit CDMO Analytics
July 21, 2026Pharmaceuticals
Manufacturing
Equipment Qualification in Pharma Manufacturing: IQ, OQ, and PQ Explained for Sponsors
July 30, 2026Cleanroom Zoning for Sterile Manufacturing: What Sponsors Should Check During Site Audits
July 25, 2026Process Validation Readiness at CDMOs: PPQ Planning Mistakes That Delay Commercial Launch
July 17, 2026Logistics & Supply Chain
AI & Automation
Quality & Regulatory
Medical Technology
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Evotec and Sandoz Explore $300M Biologics Unit Sale in Toulouse: CDMO Capacity Shifts
Evotec has entered a non-binding agreement with Sandoz to explore the $300M sale of its Toulouse biologics facility, signaling shifts in CDMO capacity and outsourcing dynamics.
Read Full Story- Biotech – June 8, 2026 The Biggest Downstream Purification Bottlenecks in Biologics Manufacturing
- Pharmaceuticals – August 1, 2026 Poorly Soluble Drug Formulation: When to Use Hot-Melt Extrusion vs Spray Drying
- Supply Chain and Logistics – July 18, 2026 Direct-to-Patient Clinical Trial Shipping: Cold Chain Risks Sponsors Often Underestimate
Latest Expert Post
Direct-to-Patient Shipments: What I Said in 2021 — and What We See in 2026
Developing biosimilars involves navigating complex manufacturing and regulatory challenges that go far beyond traditional generics. This guide explores key hurdles—from analytical characterization to large-scale production—and highlights how strategic CDMO partnerships help ensure similarity, scalability, and commercial success.
Read Full Post
Cold Chain Logistics in Biologics Manufacturing: Preventing Temperature Excursions
Maintaining the integrity of temperature-sensitive therapies is the greatest challenge in modern medicine. This guide explores how cold chain logistics biologics manufacturing protocols prevent temperature excursions, utilize real-time monitoring, and ensure regulatory compliance. Learn about specialized packaging, risk mitigation strategies, and the role of CDMOs in securing the global supply chain.
Adventitious Agent Testing in Biologics: Building a CDMO Testing Strategy That Regulators Accept
Protecting biologics from viral, bacterial, and fungal contaminants is a regulatory mandate. This 2,500-word guide details Adventitious Agent Testing strategies at CDMOs. Explore in vitro and in vivo assays, Next-Generation Sequencing (NGS) trends, and how to structure your testing program to ensure safety and clinical success.
CDMO world AI Summer Series· Launches June 15
Learn how Ai is changing pharmaceutical manufacturing — features, roundtables, live videocasts.
Original Video Programming
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Launching 5/12
Leadership Video Interview Series
Candid conversations with the CEOs, COOs, and CSOs redefining contract manufacturing.
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Now: Craig Mooney from CDSG.
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Latest: Dr. Frank Gibson on aseptic scale-up.
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A fast, focused live video broadcast covering the most important moves across the CDMO landscape — deals, capacity, regulatory shifts, and the people behind them.