Skip to content
Contact us

Lyophilization​ Services

Some pharmaceutical products are simply too sensitive and require lyophilization to maintain appropriate shelf-life and efficacy for their intended patient. Sharp Sterile offers comprehensive lyophilization services to support products from clinical through commercial production.

Our services:

All filling operations and transfer to the lyo are performed in permanently connected isolators. We also have experience with lyophilizing products within a syringe which can reduce costly waste from hold-up volumes.

Lyophilization Details:​

  • Container Sizes: Client Directed
  • Capacity: Client Directed – up to 56,000 10R​ vials with expanded capacity coming online in 2027
  • Operations: Manual, Semi-Automated, or Automated – all
  • Components: Client Specified
  • Fully isolated filling environments
  • Lyo development and optimization services

Semi-Automated Filling Line

Semi-Automated Vial Filling & Lyophilization

Our semi-automated isolator-based fill and lyophilize up to 3,500 10R vials. This line is ideal for clinical-scale lyo projects.

Processing Modes

Automated Filling Line

Automated Vial Filling & Lyophilization: Expanding Lyophilization Capacity

Our lyophilization capabilities continue to grow alongside our sterile manufacturing operations. As part of a $28 million facility expansion, Sharp Sterile is adding a new high-performance lyophilizer integrated with a fully automated IMA Life isolator-based filling line. This next-generation system supports high-throughput aseptic processing of RTU vials and strengthens our ability to manufacture commercial-scale batches while maintaining rigorous quality and sterility standards.

New Integrated Lyophilization System

  • 30m2 freeze dryer integrated with a fully automated isolator-based RTU vial filling line
  • Automated product transfer from filling through freeze drying
  • Supports capacity up to 56,000 10R​ vials
  • Designed for efficient clinical through commercial manufacturing

Sterile Manufacturing Inquiry

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

This field is for validation purposes and should be left unchanged.
Sterile Manufacturing Services
How did you hear about us?
At Sharp, we always have exciting pharma topics that we’d like to share with you. We will only contact you about topics that we think might be of interest, based on the information you provide to us.

[1]Sharp takes your privacy seriously and will only use your personal information to provide services that you have requested from us. We will not share your personal information with non-agent third parties. View our privacy policy here

This field is hidden when viewing the form
This field is hidden when viewing the form
This field is hidden when viewing the form

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

Explore more of our Sterile Filling

Sterile Vial Filling

Sterile Syringe Filling

Sterile Cartridge Filling

Terminal Sterilization

Our experience is your strength

Contact us