Our microsphere technology covers the development and characterization of biodegradable polymer microspheres, long-acting sustained-release microspheres, and targeted delivery microspheres. With extensive experience in process development, scale-up, and non-clinical evaluation, we provide comprehensive services from proof of concept to large-scale production.
Contact us to learn more about our microsphere formulations.
Obtaining microspheres using various techniques: single emulsion, double emulsion, and coacervation.
Proprietary technologies for regulating drug release from microspheres.
Expertise in manufacturing water-soluble and lipid-soluble products by using different types of additives on the capsule surface.
Experience with biopolymers from both synthetic and natural sources.
Ability to produce microspheres ranging from 5 to 200 μm.
Capability to create controlled-release formulations lasting from 5-6 days to 6 months.
Solid and proven experience in scaling up processes from laboratory to industrial scale.
Process Development and Scale-up:
Selection of lead formulations based on feasibility and in vivo study results.
Defining critical quality attributes using the target product profile.
Stepwise scale-up approach focusing on unit operations and critical process parameters.
Utilization of semi-continuous and continuous manufacturing processes to achieve consistent formulation performance.
Provision of pilot batches for preclinical studies supporting IND filings.
Capability for clinical-scale production.
Particle size and size distribution (DLS).
Morphology and surface characteristics (Zeta potential, SEM).
Chemical composition and structure (FTIR, NMR, XPS).
Drug loading and encapsulation efficiency (HPLC, UV-Vis).
Thermal properties (TGA, DSC).
Mechanical strength (compression testing, rheological analysis).
Biocompatibility.
