Sponsored Content from UI Pharmaceuticals
By Dennis Erb, Ph.D. & Julia Beasley
The terrain between concept and clinic ready formulations can be tricky to navigate, especially when working with New Chemical Entities (NCE). Partnering with a Contract Development and Manufacturing Organization (CDMO) can help alleviate the uncertainty of drug development but finding the right CDMO partner to suit your projects’ needs can be challenging- especially when those needs change throughout development. The optimal goal is to find a full service CDMO (with a wide range of services) that can support your needs for the life of the program.
Technical capability is usually the first consideration when choosing a CDMO. What capabilities does your project require and what services do they provide? Not all CDMO’s have the infrastructure, technology, or service menu to meet your project’s demands through every phase of development. Using CDMOs with limited capabilities (or only a singular area of expertise) can result in a complex web of service providers, extensive project management coordination and a high probability of delays in project timelines. A full-service CDMO -- a CDMO that offers formulation, manufacturing, and analytical testing services -- can provide a more effective approach while assuring quality and scientific robustness throughout development.
CDMOs that align formulation development with manufacturing, method development, and release testing services under one enterprise can speed development by smoothing technical transfers and minimizing logistical coordination. A full service CDMO offers clients research-based, cross-functional project oversight that maximizes quality when scaling up for clinical demands. Fewer logistical nightmares facilitate faster timelines to the clinic. Additionally, keeping your technical expertise under one roof also gives project teams more opportunities to learn the intricacies of your project. In CDMOs where formulation scientists can work directly with analytical chemists and manufacturing project managers, you’ll have a designated team of technical experts with your project from concept to clinic. This means manufacturing teams can learn directly from formulation development studies; collaborating to determine an approach that will work for your particular formulation needs.
Scale for Success
Aligning formulation studies with analytical method development and production expertise can guide decisions in the early stages of product development, but it can also help progress projects through critical milestones and ensures the scalability of your formulation to the production environment. No matter where your project begins in your partnership with a CDMO, working with a single organization rather than several locations for testing and manufacturing support will streamline your approach. Even small-scale manufacturing projects can save critical time and funding eliminating unnecessary product transfers and duplicate process validations by using a single service provider.
While technical capabilities are essential, an agile CDMO with the ability to align their strategic approach to product development with the client’s clinical strategy will foster long term program success. In early-stage development where API is limited and priceless, effective use of materials is an important consideration. Your CDMO should have an approach that will maximize experimental design to answer the most pressing questions while preserving API. Investing in development may seem like a sacrifice for speed, but a purpose-driven formulation and process developed by a CDMO with designated formulation and engineering teams may buy critical project flexibility, generate important scientific data, and ultimately save costs.
For some projects, a formulation, limited product, and an analytical characterization is all you need to enter the clinic to assess safety or proof of concept. Further development work could be continued in parallel to initial clinical trials (saving you time). Even simple formulations can present challenges when scaling up from the lab-bench but approaches that offer formulation development alongside GMP manufacturing increase the probability of project success in scaling to the clinic. Complex projects may demand a more thorough formulation development program due to the nature of the active, drug product challenges, or clinical trial design. Such projects will require more development work which will ultimately impact the cost and timeline of your project. Choosing a CDMO with experienced staff that can correctly and rapidly assess your project needs will be beneficial in constructing a phase appropriate strategy for product development leading to clinical supply manufacturing. Though project needs may vary, identifying a quality-focused partner with scientific integrity and whose strategic approach aligns with the project plan is the crucial foundation for project success.
Can your CDMO grow to support advancing your program? In early stages of product development, the availability of Active Pharmaceutical Ingredient may limit batch sizes and clinical demand for First in Human (FIH) or Proof of Concept (POC) studies may be small. Finding a CDMO partner with the capability to manufacture small clinical supply batches and scale to meet Phase 2 and Phase 3 supply demands can reduce the number of technical transfers- saving teams both time and money- but also ensures quality by sharing process information amongst internal teams as the project progresses. These CDMOs can assure consistent quality practices throughout each stage of development while building the scientific database or foundation to support regulatory registrations. If need be, this scientific database or foundation will then serve as the foundation for the technical transfer for larger scale manufacturing.
Prioritize development quality to maximize speed and minimize cost
Quality, technical expertise, services provided and adherence to cGMPs will all ultimately affect the success of your project. A CDMO that has manufacturing, analytical testing, and formulation capabilities will speed your development process, but a partner that also has an experienced quality organization is critical to assuring cGMP compliance and product quality. Finding this strategic partner in a full-service, agile CDMO will ensure a scientific approach with a quality emphasis is taken in meeting all your project needs.
Continued partnerships with CDMOs that have cross-functional testing and manufacturing facilities, means technical teams can directly apply their scientific expertise to every phase and aspect of development, but it has the added benefit of allowing teams to improve their processes according to your project’s needs. UI Pharmaceuticals has the technical capability to support drug development at any program stage. For over 45-years, this FDA registered cGMP CDMO has partnered with bio-tech start-ups, government agencies, and University research groups to develop, manufacture, and test novel treatments in sterile and non-sterile formulations.
In Fall 2023, UI Pharmaceuticals will launch production for an innovative 16,000 square foot sterile processing facility. Two fill lines feature state of the art sterile manufacturing equipment, depyrogenation tunnels, and capping stations incased in an ISO 5 integrated isolator sterilized by Vapor Hydrogen Peroxide (VHP). Top industrial equipment for compounding and transfer minimize contamination in pre-production clean-room areas. Telastar Lyophilizers, integrated to load from either fill line, maximize lyophilized batch production potential for client partners. The new facility, equipped with two fully automated lines in ISO controlled areas and designed with SCADA control, will operate in tandem with UI Pharmaceutical’s existing small-scale facility. This new facility is designed to expand the CDMO’s capabilities into advanced stages of development, investigational, and commercial drug manufacturing. To learn more about UIP's formulation, testing, and manufacturing capabilities visit them in-person at AAPS 2023 PharmSci 360 in Orlando or anytime online.