Complex Formulations

With proven expertise in complex sterile and non-sterile formulations, dedicated ISO 5 (Grade A) aseptic suites, experienced technical SMEs who guide process scale-up and transfer, and robust analytical testing capabilities, we support clients with global regulatory compliance.

Complex made deliverable

We specialize in developing and manufacturing challenging formulations, including emulsions, suspensions, liposomes, polymer nanoparticles, and lipid nanoparticles (LNPs), using a collaborative, innovative, and customized approach that drives successful delivery of complex projects from early development through GMP manufacturing.

Core capabilities

With dedicated ISO 5 (Grade A) aseptic suites, technical SMEs guiding process scale-up and transfer, and robust analytical testing capabilities, we support clients with global regulatory compliance.

Tangential Flow Filtration (TFF)
Diafiltration
Microfluidization
High-Pressure Homogenization
Aseptic Ball Milling

Sterile formulation

When sterile filtration or terminal sterilization isn't an option, we provide bespoke aseptic compounding solutions in dedicated ISO 5 (Grade A) cleanrooms. With deep expertise in novel drug products and flexible facility capabilities, we design tailored programs that take your parenteral formulation from bench scale through full GMP production.

Complex process engineering

No two manufacturing processes are the same, and our technical experts work closely with you to develop, scale up, or transfer complex formulations efficiently and safely into our GMP facilities. Whether you're in early development or ready to scale lab processes for clinical production, we ensure a seamless technology transfer tailored to your equipment and utility requirements.

Analytical testing

To support your development and GMP manufacturing, we provide comprehensive analytical characterization services that generate the critical data and insight needed to advance complex drug products with confidence, including particle size analysis, dissolution profiling (Type II and IV), oxygen headspace measurement, and gas chromatography