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Sterile Manufacturing

Sharp Sterile Manufacturing combines technical expertise and unique capabilities to accelerate your injectable to market. All fills are 100% isolator-based and use advanced technology to ensure you receive high-quality drug products with the greatest sterility assurance.
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Sterile Filling Services

Fill Lines

Stability Programs​

Pharmaceutical Analytical Services

Development

Learn more about Sharp Sterile

We specialize in isolator-based fill/finish of vials, cartridges and syringes from clinical phase through small to mid-scale commercial production. Sharp’s Sterile Manufacturing business (formerly Berkshire Sterile Manufacturing) is a specialist CDMO providing sterile injectable development and manufacturing services including:

  • 100% Isolator-Based Sterile Filling
  • Lyophilization
  • Formulation Development
  • Analytical Support
  • Stability Studies
  • Terminal Sterilization

All lines are equipped with Colanar™ fillers offering the flexibility for vials, syringes and cartridges to be filled on the same line. From clinical to commercial, our team has the deep technical expertise, broad experience and end-to-end manufacturing, packaging and distribution solutions to seamlessly accelerate your injectable to market.

Technical Capabilities

  • Formulation suites
  • Filling rooms with isolator-based sterile filling lines
    • Filling of syringes, vials and cartridges
    • Lyophilization capability
    • Viscous and complex formulations
  • Wash rooms/component prep rooms
  • Fully equipped analytical lab for onsite analytical support and stability studies
  • Onsite microbiology lab for in-house microbiology testing

Sterile Manufacturing Inquiry

Would you like to find out more about our clinical services? Fill the form below so we know what area you’re interested in and we’ll be very happy to help.

Sterile Manufacturing Services
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To find out more about our sterile manufacturing services, please contact:
 Cristin Grove, Vice President Business Development

Trusted by many

“The people at Sharp are collaborative, responsive and always willing to accommodate our needs, and this is something to be admired. If they say they can do something, they will deliver no matter what – ultimately, their success is our success, and vice versa.”

Sr Quality Supplier Manager, Top 10 Pharmaceutical Company

“Sharp’s responsiveness and flexibility are truly gold standard. Their dedication to the core values of quality and service allows for a true partnership and success in getting our product to patients in need.

External Manufacturing, Top Mid-size Pharma Company

“Sharp is an exceptional partner in the packaging CMO space. They have a dedicated launch team which is unique and a huge benefit vs. having the project lead that handles commercial business also manage the launches. Launches can be very time consuming and they can focus on these activities vs. having to also manage the commercial side.

Top 10 Pharmaceutical Company
Learn more about Sharp

Sharp is a leader in pharmaceutical packaging, clinical trial supply services & small-scale sterile manufacturing, with a heritage spanning more than 70 years.

Our commitment to quality is proven through exceptional credentials and a history of strong compliance with successful inspections and approvals from regulators around the world.

We are committed to limiting our environmental impact and protecting the planet for future generations by measuring it today.

Our employees work from state-of-the art facilities and share our vision of delivering world-class services in clinical trial supply and commercial packaging services.