Integrated Development Solutions

OVERVIEW

OptiForm® Solution Suite      Xpress Pharmaceutics®      Optiform Total Supply

You’re faced with many challenges when developing a new therapy: technical, timing, resources, funding, and patient needs. The path to your first in human clinical studies needs to be as fast and efficient as possible, but improper candidate selection, poor formulations, and gaps in clinical dose strategy can lead to unsatisfactory preclinical and clinical data and ultimately to extended timelines and increased costs.

A program which includes and seamlessly integrates everything you need to select the right candidate, assess its optimal form, enhance its bioavailability, and deliver cGLP and cGMP materials for testing can save you time and money. Catalent helps its partners turn promising molecules into better treatments with its “Follow the Molecule®” approach that provides accelerated integrated solutions from development to commercial supply.

Our integrated solutions include Optiform® Solution Suite and Optiform Total Supply

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OPTIFORM® SOLUTION SUITE

A data-driven parallel screening approach to quickly and efficiently solving complex bioavailability and formulation challenges for poorly soluble compounds. We’ve designed OptiForm® Solution Suite with best practices based on our years of successful development experience to help you get it right the first time. At each step in OptiForm® Solution Suite we have developed ways to accelerate your progress, reduce risks, and get you to key decision points quickly.

OptiForm® Solution Suite includes:

1. Solubility tools and predictive DMPK to move more molecules into development during Candidate Selection.
2. Comprehensive Preformulation to characterize the properties and challenges specific to your molecule.
3. Formulation Selection including parallel screening of proven bioavailability enhancement technologies for challenging molecules.
4. Formulation development for GLP toxicity studies to ensure safety and appropriate exposure.
5. Formulation & cGMP Manufacturing for Phase I with expert dose development and design services for conventional or enhanced dose forms.

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NEW CATALENT XPRESS PHARMACEUTICS™

A more advanced development offering that integrates formulation development with clinical manufacturing, regulatory support and clinical testing, to help achieve flexible and efficient First-in-Human studies and fast development. At the center of this program is the ability to adjust both formulation and dose based on real-time clinical data, using on-demand manufacturing approaches and adaptive clinical design protocols. This offering helps optimize and accelerate overall development process by reducing stability requirements, which can lead to significant reductions in costs, time and the amount of API necessary.

Xpress Pharmaceutics® includes:

• Formulation Development
• Stability of Generated Products at the Limits of Dosing Range
• GMP Manufacturing of Bulk, Scalable Intermediate
• ‘On-Demand’ Manufacturing at the Clinical Site
• Iterative Dosing, Review of Clinical Data, and Decision Making
• Regulatory Support

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OPTIFORM TOTAL SUPPLY

Using an integrated approach and performing activities in parallel, we reduce your overall project risk and timeline to get your promising medications from development to clinic faster. OptiForm^® Total Supply helps clinical sponsors simplify development, accelerate their timeline and reduce risk through the integration of:

• Development formulation
• Clinical manufacturing
• Demand forecasting and clinical supply management
• Clinical packaging, labeling, storage and distribution (Phase 1-3)