Formulation Development

Nitrosamine Risk Management: Your Questions Answered

Navigate nitrosamine impurities with early risk assessments, trace-level analytical testing, and careful excipient evaluation. Learn strategies to strengthen compliance and optimize testing programs.

Advancing Reconstitutable Injectables: Aseptic Powder Filling & Dual Chamber Delivery

Spray-dried powders, gravimetric filling, and dual-chamber syringes are converging into one development pathway for reconstitutable injectables, raising the question of how formulation, filling accuracy, and device design should be evaluated together.

Choosing The Right Solid Form

Mastering polymorph screening helps prevent costly reformulation delays. Explore phase-appropriate strategies, experimental methods, and structural informatics for crystal form selection.

From Biomarker Data To Proof Of Mechanism

Biomarker values support mechanism only when the decision, analytical plan, and validation are designed as one chain, with expected direction of change and baseline noise defined before sampling.

Difficult-To-Purify And Difficult-To-Filter Small Molecules

Poor filterability and stubborn impurities often trace back to the same molecular features, which changes how development teams approach scale-up for larger, structurally complex small molecules.

Building Confidence In Combination Product Development

Early compatibility testing with realistic placebo models helps mitigate formulation risks, ensuring accurate dosing, predictable injection times, and long-term stability.

From Early Development To Commercial Launch: An End-To-End Partnership

Bringing a critical therapy to market takes early coordination. See how strategic planning helped accelerate an oncology therapy from clinical development to patients.

Selecting The Right Chromatography Strategy

Difficult small molecule purifications rarely yield to one technique. Modeling, fraction mapping, and preparative HPLC each solve a different problem, and the right choice depends on the molecule.

Optimizing Particle Properties For Difficult Small Molecules

Crystal morphology and unexpected solid-state intermediates often decide whether a difficult small molecule filters, dries, and scales. Thermodynamic stability may not be the right target.

Turning A "Brick Dust" Compound Into A Clinically Viable Oral Formulation

Advanced wet milling and particle stabilization improve solubility, enhance bioavailability, and support scalable manufacturing for complex oral drug development programs.