Formulation Development

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.

Choosing The Right CDMO For Substance Development And Manufacturing

Controlled substance programs demand licensing, closed-system custody, and inspection history well beyond GMP. Sponsors weighing partners must test technical depth against compliance infrastructure.

Expert Q&A: Navigating Complexity In Modern Small Molecule Development

Small molecules are growing larger, more potent, and more structurally complex while timelines compress. That combination reshapes scale-up, outsourcing relationships, and the criteria for choosing a manufacturing partner.

A Connected Approach To OSD Development

See how an integrated OSD development strategy can identify risks early, strengthen process understanding and prepare products for scale-up, tech transfer and commercialization.

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.

Creating A New Dosage Form From An Approved Drug For A New Rare Disease

Advancing approved drugs into new indications requires smart formulation, strong quality controls, and regulatory expertise to overcome challenges and accelerate patient access.