Crystallization & Particle Engineering

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Crystallization & Particle Engineering Platform

Apeloa has integrated its resources and expertise in solid-state chemistry into the Crystallization & Particle Engineering Platform (CPEP). CPEP has established itself as a market leader in crystallization and particle engineering services over the years. This platform is led by experienced crystallization scientists and equipped with advanced analytical instruments and state-of-the-art development facilities across different scales. Apeloa can customize its service to clients through competencies in particle characterization，solid-form screening, crystallization development, trouble-shooting and optimization of crystallization processes, particle engineering via milling and spray-drying.

20 ⁺

years of experience in crystallization and particle engineering
10 ⁺

advanced analytical instruments
50 ⁺

projects completed annually

Team

CPEP has a team of over 20 experts with extensive knowledge and experience in crystallization and particle engineering. More than half of them has PhD or Master degree in chemistry, chemical engineering, or pharmaceutical engineering. The team has complet

Services

Solid-form screening for NCE at different development stages, including salts, co-crystals, polymorphs, solvates，hydrates and amorphous state.

Fit-for-purpose crystallization development.

Systematic crystallization development from grams to kilograms, including solvent screen, solubility and meta-stable zone width measurement, screen of process parameters, DoE and robustness studies.

Crystallization trouble-shooting and optimization to control crystal size, polymorph, purity, crystal habit, solvent residue, and occurrence of oiling out.

Chiral separation via crystallization.

Size reduction via dry milling or wet milling, integraiton of wet-milling with crystallization.

Spray drying

Particle characterization using microscopy, XRPD, TGA, DSC, DVS, HPLC.

Powder characterization in terms of flowability(bulk density and repose angle measurement), compactability, compressibility, etc.

Solid-state stability evaluation and dissolution studies.

Advantages

● Seamless integration of chemical synthesis, soild-form screen, crystallization development and powder engineering of small-molecules at different development stages across varying scales. Customers can trust the research, development and manufacture of their APIs to one single cross-department team of Apeloa. No pains of often inefficient tech transfer between different service providers. ● Mechanistic understanding is emphasized in CPEP with the help of multiple tools such as PAT, process modelling, DoE, data mining, etc. Thorough evaluation is conducted of differences in mass tranfer, heat transfer and momentum transfer across scales to get it right at the first time upon scale-up. ● Leveraging on the expertise of engineering and formulation teams to create optimal processes and products that need minimal modifications as development progresses.

Equipment

CPEP is equipped with advanced solid-state characterization instruments and process analytical technology probes for process development. Apart from those shown in the figure, NIR, NMR, SEM, etc. can come in when needed. When it comes to micronization and milling capabilities, CPEP has expertise in hammer milling, jet milling, high-shear wet milling, wet bead milling, and spray drying.