Formulation Development
CuriRx’s expertise spans a wide range of pharmaceutical formulation areas, focused on optimizing for stability, solubility, and delivery of drug compounds. These services are essential for pharmaceutical companies looking to develop safe and effective drug products, from early preclinical and clinical development stages, from early preformulation studies to scalable manufacturing processes.
CuriRx specializes in pharmaceutical formulation development, particularly in injectables/parenteral, like intravenous, subcutaneous, intramuscular, intrathecal, and ocular formulations. These injectables are delivered as liquid, lyophilized, nanoparticles, micro and nanoemulsions, and complexation dosage forms.
Our formulation development is tailored to meet your clinical programs or commercial market needs. We approach each formulation project by understanding the target profile for your product, and custom design the program based on your clinical needs. The goal is to have an effective, easy-to-administer dosage form with the right quality attributes that will increase patient compliance and minimize dosing discrepancies during clinical trials.
CuriRx has successfully developed formulations for all classes of molecules antibodies (Antibody-drug conjugates, monoclonal, polyclonal, bispecific, nanobodies), protein, oligonucleotides, viral vectors (AAVs) non-viral vectors, vaccine, peptides, small molecules and microbiomes.
Our formulation expertise includes the following:
- Stabilizing molecules through formulation and excipient selection
- Developing high- and low-concentration antibody or protein formulations
- Concentration, viscosity, syringeability and injectability assessment</
- Increasing the solubility of water-insoluble molecules
- Nanoparticles and microparticle delivery systems
- Emulsions and liposomes
- Formulation development for early preclinical studies
- Developing easy scalable formulation processes
- Robustness studies DOE design and Forced degradation studies
- Bed-side or in-use stability study
✔ Small molecule: Stability Fingerprinting®
✔ Biologics: Solubility Fingerprinting®
✔ Identify stability-indicating assay
✔ Screening(buffers, stabilizers, etc)
✔ Instrumentation: LyoStar II-FTS Lyophilizer (2)
✔ Facilitate global transport and storage
✔ Withstand adverse environmental challenges
✔ Enable to move through clinical trials expeditiously
✔ Deliver types: Injectible, Oral, Topical
✔ Size
✔ Encapsulation
✔ Loading efficiency
✔ Drug release profiles