Lonza boosts solid form services for small molecule APIs

The expanded and refined first-in-human services have been designed to meet the early-stage molecule development of small biopharma players

The increased service capabilities complement the company's API development and SimpliFiH Solutions first-in-human services consisting of phase-appropriate drug substance and drug product development and manufacture.

The company claims its solid form services offering also enhances its capabilities in meeting accelerated timelines for increasingly complex molecules.

Lonza's Michael Grass, Director of Solid Form Services — Small Molecules, said its methodology is "aimed at thorough solid form selection to ensure that all options for drug substances and drug product are considered early in the development process."

The selection of a lead solid involves the screening and characterization of both chemical forms (salts, cocrystals, solvates) and the associated polymorphs.

Every molecule has a different propensity for polymorphism and to form hydrates and solvates.

The molecule's physicochemical properties and the target product profile dictate the need for screening salts, cocrystals, or bioavailability-enhanced formulations, and the key properties of any solid form: solubility, dissolution rate, manufacturability, stability, and so on.

Effective screening and selection are critical for early-stage and late-stage development to further process risk reduction and/or strengthen intellectual property claims.

Commenting on service expansion, Christian Dowdeswell, VP and Global Head, Commercial Development – Small Molecules, Lonza, said: "Choosing the right solid form and identifying the interplay between solid form and drug product is critical in the rapid advancement of molecules while minimizing risk and cost. Our expanded solid form services offering is designed to meet the early stage molecule development of small biopharma players.”