Sharp Sterile Manufacturing

Sharp Sterile Manufacturing (formerly Berkshire Sterile Manufacturing) is a contract manufacturing organization specializing in sterile fill-finish services and related development capabilities.

Core Services:

• Sterile filling operations across multiple platforms: vial filling, prefilled syringe filling, and cartridge filling
• Lyophilization services and lyophilization development
• Formulation development and method development
• Analytical services
• Stability programs
• Packaging and distribution support
• Terminal steam sterilization

Manufacturing Infrastructure: The facility operates multiple filling lines ranging from manual to fully automated configurations, enabling flexibility for clinical and commercial-scale production.

Development Capabilities: Beyond manufacturing, the organization offers development services including lyophilization process development, formulation optimization, and analytical method development to support clients from early development through commercialization.