Development Solutions

• Existing generic manufacturing companies
• Government agencies looking to secure a self-contained API supply chain
• Self-contained health systems looking to make their own product
• Healthcare payers looking for their own capability to supply their patients with essential medicines at reasonable cost
• Any non-profit or NGO organization looking to address the issue of essential medicine availability

Consultation

Consulting services include high-level strategy for the compound of interest and the related continuous manufacturing approach.

Design

Design services elaborate the development of potential synthetic routes for the compound of interest, establishing a specific approach and related equipment for continuous manufacturing. Key focus is on API manufacture, with options to pursue fill or finish capability based on established drug product form.

Lab Scale Development

Based on continuous manufacturing design outcomes, lab scale development services include assembling required process steps and minimal monitoring equipment to validate the options presented in design.

Manufacturing Scale Development

Manufacturing scale development incorporates the knowledge and expertise of the Continuity Pharma team, partners, and collaborators to establish a robust production unit for the individual API compound of interest. Equipment qualification to meet cGMP requirements is available as an optional service.

End-to-End Manufacturing Capability

End-to-end manufacturing services includes manufacturing scale development and integration with fill and finish partners for full drug product delivery in specified final dosage forms. cGMP qualification of equipment, production of materials for analytical testing, and production of drug product for bio-equivalence studies are available as optional services.