Formulation Development

Why Reagent Quality Defines Research Success

Water grade, buffer preparation, and packaging each shape whether sensitive assays hold up. Reagent selection hinges on matching purity to application sensitivity, regulatory standards, and tolerance for contamination risk.

Peptide Building Blocks: Navigating Quality, Supply, And Scale

Non-canonical amino acids can boost peptide half-life and potency, but create challenges in impurity control, GMP classification, and sourcing. Early supplier choices are critical for commercialization.

Accelerating Complex Generic Drug Development Through Advanced Deformulation

With FDA no longer identifying Q1/Q2 differences, applicants bear the diagnostic burden. Reverse engineering now directly affects development speed, cost, and approval.

Why Audit Success No Longer Predicts Clinical-Stage Performance

Passing inspections no longer signals that a growth-stage biotech can sustain clinical-stage complexity. The gap between audit readiness and operational readiness opens quietly.

Practical Formulation Strategies For Poorly Soluble APIs

Poor aqueous solubility now defines most drug candidates in development, making early screening and solid-state assessment essential to achieving reliable exposure and avoiding costly reformulation downstream.

Why Early Device Decisions Matter: How Immunovant Accelerated Its Program

Deferring autoinjector selection can seem to preserve flexibility, yet it often moves constraints downstream. Integrating the device during Phase IIb changed one program's timeline and removed bridging work.

Using Human-Centered Engineering To Improve HPLC Solvent Handling

Real-world HPLC workflows show how closed-system solvent handling can address contamination, downtime, and waste across laboratory settings.

Reducing Cycle Time By 88% Through Strategic Solvent Replacement In Pharmaceutical Development

Replacing methylene chloride in a slow, labor-intensive API step led to a single-solvent, one-pot process with a shorter reaction time and improved yield and purity.

Improving Stability Through Science-Led OSD Reformulation

A marketed multivitamin tablet spanning a 0.03% to 46% w/w range failed early in accelerated stability testing. Mechanism-led reformulation and a switch to direct compression changed the outcome.

De-Risking Complex Generic OSD Development

Complex generic tablet development requires early alignment of regulatory strategy, QbD formulation, discriminatory dissolution, and reference-scaled bioequivalence.