Contract Lyophilization

With more than three decades of lyophilization experience focused on the diagnostics industry and over 1,000,000 square feet of facilities in Tecate and Tijuana, Scantibodies is ready to assist you with your current lyophilization needs. Our portfolio of services includes formulation, cycle optimization, automated filling, and capping. You can be assured that Scantibodies will produce your product to the highest quality at either of our two ISO 13485, cGMP certified, FDA registered facilities.

One of the world’s largest contract lyophilization facilities for diagnostic products

Automated Filling and Capping

• Can accommodate vial sizes from 2 mL to 11 mL
• 100% weight check of filled vials available
• Capacity up to 300 containers per minute (assuming a 0% weight check)
• Capacity up to 125 containers per minute (assuming a 100% weight check)
• Filling under HEPA filters
• Inline stoppering
• Vials placed in trays automatically

LYOPHILIZATION CAPACITY

 

2,756 sq. ft. of lyophilization shelf capacity

Up to 1,295,928 2mL tubes per load

Up to 487,290 7mL vials per load

HULL 36

 

36 sq. ft. of shelf capacity

17,712 2mL Tubes per load

6,660 7mL Vials per load

STOKES 72

 

72 sq. ft. of shelf capacity

35,424 2mL Tubes per load

13,320 7mL Vials per load

VIRTIS 96

 

96 sq. ft. of shelf capacity

47,232 2mL Tubes per load

17,760 7mL Vials per load

STOKES 120

 

120 sq. ft. of shelf capacity

58,056 2mL Tubes per load

21,830 7mL Vials per load

HUDSON VALLEY LYOMAC

 Two Units

200 sq. ft. of shelf capacity

76,752 2mL Tubes per load

28,860 7mL Vials per load

EDWARDS 236

 

236 sq. ft. of shelf capacity

88,560 2mL Tubes per load

33,300 7mL Vials per load

HULL 220

 

220 sq. ft. of shelf capacity

108,24 2mL Tubes per load

40,700 7mL Vials per load

HULL 733

 Two units

733 sq. ft. of shelf capacity

339,480 2mL Tubes per load

127,650 7mL Vials per load

Labeling and Packaging

• In-house label design and production capabilities
• Temperature controlled manufacturing environments
• Six validated semi-automated packaging lines
• FDA / CE mark requirements for UDI (Unique Device Identification)
• Packaging of up to 470,000 kits per week

Warehousing, Fulfillment and Transportation

• Temperature monitored warehouses
• Conveniently located minutes away from major shipping hubs such as FedEx and UPS
• Short-term & Long-term storage availability
• Transportation varying in capacity from 12 pallets to 30 pallets
• All transportation units are equipped with GPS Tracking software
• Transportation temperature management capabilities:

-Ambient
-Refrigerated: +2°C to +8°C
-Frozen: 0° to -20°C

Frequently Asked Questions – FAQs

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What are the advantages to work with Scantibodies?
  • The Scantibodies team is bringing decades of lyophilization experience to our broader manufacturing portfolio. You can expect a practical approach to lyophilization projects. We know what works, and your project reaps the benefits.
  • Flexible lyophilization technology suitable for a range of batch sizes.
  • Integrated software features provide process control and monitoring which enable real-time analysis and optimization.
  • Unparalleled ability to understand thermal events during the freezing and primary drying for continuous process protocol improvement and transfer.
What additional services does Scantibodies offer?

Visual Inspection

After your batch is complete, SLI’s certified technicians will perform a 100% manual visual inspection of the finished product.

Labeling and Packaging

Scantibodies can manage your labeling and packaging needs and perform non-blinded clinical labeling, ink-jetting, packaging, and kitting.

Analytical Testing

Please take advantage of our in-house GMP analytical testing services to speed turnaround and expedite your timeline. (Moisture analysis, UV/VIS, pH, and more.)

Controlled Temperature Storage

Scantibodies offers cGMP validated storage at controlled room temperature, refrigerated and frozen conditions for incoming raw materials and finished products.

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