Experienced Formulation Development for Pharmaceutical and Biotech Innovations
With decades of collective expertise, our Formulation Development team excels in advancing pharmaceutical and biological products from concept to market. We work alongside government agencies, academic institutions, and biotech industry leaders to transform new chemical entities into clinical and commercial successes, ultimately enhancing patient Quality of Life (QoL).
Leading the Way
Comprehensive CDMO Services Tailored to Your Project
Our wide-ranging suite of services spans the entire product development lifecycle, providing precise, fit-for-purpose solutions. We specialize in handling diverse product types, including both sterile and non-sterile formulations. Whether it's New Drug Applications (NDAs) like 505(b)(1) and 505(b)(2), Abbreviated New Drug Applications (ANDAs), or biosimilars, our expertise ensures your project is in capable hands.
Innovative Solutions for Unmet Medical Needs
Our process development and optimization capabilities are designed to address unmet medical needs across various therapeutic areas. By leveraging our deep industry knowledge, we work with a broad spectrum of molecules to provide innovative solutions that meet the highest standards of safety and efficacy.
Our Formulation Development department specializes in a diverse range of therapeutic categories, including:
Alzheimer’s disease treatments
Traumatic Brain Injury (TBI) therapies
Emergency cardiac care medications
Osteoarthritis management
Glioblastoma interventions
Advanced cancer care solutions
Our commitment to innovation propels us to excel in these areas, ensuring that each formulation is crafted to deliver maximum therapeutic benefit.
Our Capabilities
Pre-formulation Studies
- Chemical characterization of API: particle size distribution, polymorphism, bulk/tap densities, melting point, water content, and more.
- Evaluation of API solubility and stability in solution form.
- Short-term excipient compatibility studies.
- Pre-formulation screening for liquid dosage forms.
- Filter compatibility studies for sterile dosage forms.
Formulation Development
Sterile Products: Fill/Finish such as simple solution, frozen solution, and lyophilized product in various vial configurations.
Non-Sterile Products: Direct API in capsules, blend in capsules, granules in capsules, tablets (Immediate, Sustained, Extended Release), oral solutions, elixirs, suspensions, topicals (solutions, sprays, suspensions, ointments, gels, lotions, creams), and nasal solutions.
Lyophilization Cycle Development
- Thermal Analysis Data: Utilizing Differential Scanning Calorimetry (DSC) and Freeze-Dry Microscopy (FDM) to identify critical temperatures. Creating a lyophilization cycle ensuring excellent reconstitution behavior and scalable for future production.
- Gap Analysis: Addressing scientific justification gaps in existing lyophilization cycle parameters and optimizing clinical batch manufacturing.
Lyophilization Technology
A Strategic Approach for Developing Stable Biological Injectables
Manufacturing Process Development
- Comprehensive process development services alongside formulation development.
- Expert insights and recommendations on manufacturing processes.
- Seamless transfer of formulation and technology from third-party CRO to UI Pharmaceuticals’ manufacturing workflow.
R&D Stability on Finished Products
- Stability testing within an R&D environment.
- Comprehensive stability analysis from short-term to long-term studies.
Pilot-Scale Manufacturing
- Expanded non-sterile product development capabilities with a new hybrid lab (Spring 2024).
- Pilot-scale manufacturing and DOE studies for process understanding before clinical batch manufacturing.
- Integration of services to reduce costs and enhance flexibility.