Lonza Expands Solid Form Services for Small Molecule Drugs 17th February 2021
- Solid Form Services encompass all aspects of solid form screening and characterization of small molecule APIs
- Offering designed to complement Lonza API development services and first-in-human services offering aimed at the rapid advancement of small molecules
- Based at Lonza Center of Excellence for bioavailability enhancement in Bend, OR (USA)
Quote from Christian Dowdeswell, VP and Global Head, Commercial Development – Small Molecules: “We continue to expand and refine our first-in-human services based on what our customers are telling us. 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.”
Quote from Michael Grass, Director of Solid Form Services – Small Molecules: “The overwhelming majority of new organic compounds have multiple forms and each drug and indication may require a tailored approach to lead form selection. Our methodology, which builds on core competencies in material science and problem statement identification, 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.”
Lonza announced an expansion of its solid form selection services based at its Bend, OR (USA) site. The increased service capabilities and dedicated team complement previously established SimpliFiH® Solutions first-in-human services consisting of phase-appropriate drug substance and drug product development and manufacture. The solid form services offering also enhances Lonza’s capabilities in meeting accelerated timelines for increasingly complex molecules. 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, etc. Effective screening and selection are critical for early-stage and late-stage development to further process risk reduction and/or strengthen intellectual property claims. Lonza’s solid form services are comprehensive, including form and salt/cocrystal screening, solid state characterization, chemical composition, solubility and dissolution, and powder properties.