Experienced Formulation Development for Pharmaceutical and Biotech Innovations
Leading the Way
Comprehensive CDMO Services Tailored to Your Project
Our comprehensive suite of services encompasses the entire product development lifecycle, ensuring solutions that are precisely fit-for-purpose. From New Drug Applications (NDAs), including both 505(b)(1) and 505(b)(2), to Abbreviated New Drug Applications (ANDAs) and biosimilars, we are equipped to handle diverse product types, including sterile and non-sterile formulations.
Innovative Solutions for Unmet Medical Needs
Our process development and optimization capabilities are designed to address unmet medical needs across various therapeutic areas. We work with a broad spectrum of molecules, leveraging our deep industry knowledge 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, and 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
- Conducting chemical characterization of API, including particle size distribution, polymorphism, bulk/tap densities, melting point, water content, and more.
- Evaluating API solubility and stability in solution form.
- Performing excipient compatibility studies in the short-term.
- Carrying out pre-formulation screening studies for liquid dosage forms.
- Undertaking filter compatibility studies for sterile dosage forms.
Manufacturing Process Development
- Offering comprehensive process development services in conjunction with our formulation development services.
- Our expert team provides valuable insights and recommendations on manufacturing processes.
- Assisting clients in seamlessly transferring their formulation and technology from a third-party CRO, ensuring smooth integration into UI Pharmaceuticals’ manufacturing workflow.
Lyophilization Cycle Development
- Thermal Analysis Data – Utilizing data to identify critical temperatures with Differential Scanning Calorimetry (DSC) and Freeze-Dry Microscopy (FDM). Creating a lyophilization cycle that ensures a freeze-dried product with excellent reconstitution behavior. Developing a robust process that is scalable for future production needs.
- Gap Analysis – Performing gap analysis to address the absence of scientific justification in existing lyophilization cycle parameters. Providing recommendations to optimize clinical batch manufacturing for successful outcomes.
Formulation Development
Sterile Products – Fill/Finish such as simple solution in vial, frozen solution in vial, and lyophilized (freeze-dried) product in vial. Different configurations of vial are available.
Non-Sterile Products – direct API in capsules, blend in capsules, granules in capsules, tablets (Immediate Release, Sustained Release, Extended Release), oral solutions, elixirs, and suspensions, topicals including topical solutions, sprays, suspensions, ointments, gels, lotions, creams, and nasal solutions.
Pilot-Scale Manufacturing
- In the spring of 2024, we expanded our non-sterile product development capabilities with the addition of a new lab featuring a hybrid environment.
- This new lab enables clients to leverage pilot-scale manufacturing and conduct DOE studies for better process understanding prior to clinical batch manufacturing.
- The integration of these services reduces process costs and enhances flexibility.
R&D Stability on Finished Products
- Our team provides stability testing on the finished product within an R&D environment.
- We conduct comprehensive stability analysis, ranging from short-term to long-term studies.