Drug Product Enhanced Capabilities
Author: Michelle Gischewski, Scientific Advisor – Drug Product Operations, Eurofins CDMO Alphora Inc.
Eurofins CDMO Canada has just completed over $3M in investment to enhance its capabilities in clinical drug development of poorly soluble compounds. The capital investment targets a wide range of technologies focused on solubility enhancement, particle size reduction, and process scale up. Amorphous dispersion and nano-milling are two of the many strategies offered at Eurofins CDMO to address poorly soluble compounds and support of pre-clinical through late-stage clinical programs.
Rendering molecules amorphous through spray drying has now expanded at Eurofins CDMO Canada from the gram scale to multi-kilo scale with the addition of a GEA Mobile Minor spray drying system. The production spray drying system is housed in a dedicated ISO Class 8 clean room with specific controls for solvent and highly potent material handling.
The strategy of particle size reduction through jet mill micronization, has also been a focus at Eurofins CDMO for early feasibility studies and clinical manufacturing at gram and multi-kilo scale. Nano-milling and nano particle size analysis have now been added to complement the existing micronization technologies at the site. The addition of a Dyno wet mill now expands our particle size reduction capability into the nano range, which benefits early GLP toxicology and pre-clinical formulation development and exploration, especially where nano-suspension or nano-emulsion strategies are required based on target dose and solubility profiles. To complement the Dyno wet milling technology, a Malvern Zeta Analyzer has been added to our broad range of analytical technologies. The Zeta Analyzer also has the added benefit of serving a dual purpose, suspension characterization and nano-particle measurement analysis.
Several macro scale production technologies have also been added to Eurofins CDMO Canada operation. Our existing wet granulation capability has expanded in scale with the addition of a 65L Freund Vector granulator. The bottom driven model is also equipped with a jacketed bowl system allowing for traditional wet powder granulation as well as semi-solid granulation with heating or cooling capability.
Complementary blending has also increased to the 30 Kg range with the addition of new blending drives with various shell/bin sizes. Specialty granulation, coating and drying capabilities have also expanded with the addition of Vector Freund fluid bed granulation-dryers. The new systems are multi-purpose technologies which allow for multi-particulate coating and layering, top spray granulation and traditional fluid bed drying. The systems range in scale from 2L laboratory scale for formulation development up to 20L production scale, complementing the newly added 65L wet granulation capability.
With over $3 M in capital investment, Eurofins CDMO Canada is now positioned to advance clients programs from pre-clinical completely through late stage clinical and orphan indication commercial operations. Our complement of services is wide ranging and address the various characteristics of poor solubility, high potency, and solvent handling.
