CRYSTALLIZATION AND PARTICLE ENGINEERING PLATFORM
Apeloa CDMO has integrated its resources and capabilities in solid chemistry into a Crystallization and Particle Engineering Platform (CPEP). This platform is led by experienced crystallization scientists, equipped with advanced analytical instruments and state-of-the-art development facilities across different scales. Apeloa CDMO can serve its customers better with competencies in solid-form screening and preliminary assessment, particle characterization, crystallization development and optimization, and particle micronization.
RECOGNIZED CRYSTALLIZATION EXPERTS
Apeloa CDMO has built its scientific expertise by bringing on leading scientists and engineers to support the expanding service offering. With is growth in demand and technical benefits of crystallization and particle sizing technologies, Apeloa CDMO has expanded its faculties, equipment, and analytical instruments to become a market leader in crystallization services. With a dedicated team of crystallization specialists.
CRYSTALLIZATION SERVICES ACROSS THE LIFE CYCLE OF SMALL-MOLECULE DRUGS
Apeloa CDMO aspires to be a one-stop service center where customers can entrust their drug candidates at various development stages, whether it is solid form screening, characterization and evaluation, fit-for-purpose or systematic crystallization development. Our services include:
- Early-stage solid form screening, including salt, co-crystal, polymorph, solvate, hydrate
- Characterization of powders using microscope, PXRD, TGA, DSC, DVS, HPLC
- Conversion between different solid forms
- Chemical stability assessment of solids
- Dissolution study
- Fit-for-purpose crystallization development
- Systematic crystallization development from gram to kilogram scale
- DoE and robustness study
- Crystallization optimization for control of crystal size, polymorph, purity, crystal habit, solvent residue, occurrence of oiling out (LLPS)
- Chiral resolution via crystallization
PARTICLE MICRONIZATION DEVELOPMENT
Micronized or even nano-sized particles are needed in many dosage formulations. Micron-sized particles of some APIs can be directly generated via fast precipitation in anti-solvents. However, the success of direct precipitation relies on the solubility profile and crystallization kinetics of the APIs. In comparison, milling is more often employed to reduce the particle size of many APIs. With extensive in-house milling capabilities, Apeloa CDMO team can develop micronization processes to deliver the desired particle size.
- Hammer Mill: similar to “pin-milling”, it is a mechanical milling process that can reduce particle size to 50-100 µ
- Jet milling: a dry milling process, resulting in particle sizes as low as 1-10 µ
- High-shear wet milling: reducing particle size in a slurry to around 20 µ
- Wet bead milling: producing sub-micron particles, depending on the size of beads in the mill.
- Spray drying: used to dry slurries from wet milling or generate particles from solutions via fast evaporation of solvents.
ADVANCED PARTICLE CHARACTERIZATION INSTRUMENTATION
Using state-of-the-art analytical instruments, our solid-state chemists are able to characterize a wide range of material properties, including crystal structure, hygroscopicity, particle morphology, particle size, purity, flowability. A comprehensive characterization ensures production of high-quality functional materials and enables detection of possible in-process form changes.
PROCESS ANALYTICAL TECHNOLOGY (PAT)
Crystallization scientists place emphasis on the mechanistic understanding of crystallization and particle engineering, which is the key to development of robust and scalable processes. PAT sensors afford real-time information on solution composition, solids concentration and polymorphic transformation. Combined with process modelling, the real-time information leads to understanding of various mechanisms at work. Apeloa CPEP is equipped with the following PAT sensors.
- Mettler-Toledo PVM (particle vision measurement)
- Mettler-Toledo FBRM (focused beam reflectance measurement)
- Mettler-Toledo Probe-based Raman spectroscopy
- Bruker ANTARIS II FT-NIR analyzer (near infrared spectroscopy)