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Numerous advantages of freeze-drying reagents have been documented, with the most significant one of all being the ability to sustain the ingredients‘ activities at room temperature.

This process requires highly professional and repetitionary-condition optimizations.

At Leadgene, our innovative LEADSPHERE™ lyophilization technology serves as a platform to ease the development of your reagents in lyophilized and in stable sphere format while maintaining the components’ bioactive condition at room temperature for at least 12 months.




What are the benefits of the freeze-drying format?

  • No more cooling system
  • Reduced assay turnaround time
  • Ease of handling for IVD tests
  • Ideal for point-of-care testing



Why choose LEADSPHERE™ technology?

  • Sphere format to ease aliquot
  • Assure activities of your biomolecules
  • Work with 20 μl mixture (~ 3.3 mm diameter) or more
  • Fully custom process and customer support


Molecules that can be used in LEADSPHERE™ technology:

Antibodies, Proteins, Enzymes, Chemicals, PCR Mixture



Employing an endopeptidase, LEADSPHERE™ Proteinase K, used for DNA or RNA sample preparation by digesting proteins and inactivating ribonuclease is a notable example of LEADSPHERE™  lyophilization technology. 

LEADSPHERE™ Proteinase K, provided in a lyophilized sphere format, not only has all the advantages of LEADSPHERE™ technology, such as product stability and high-temperature tolerance, but it also has other benefits in multiple aspects:


 1. Supports “pick and place” automation system for commercial-scale production.

2. Reduces pipetting step and simplifies protocols for end users.

3. Allows direct mixing with various sample types such as saliva, blood, or samples in trace quantities.





proteinase k

LEADSPHERE™ Proteinase K completely digests bovine serum albumin (BSA)

BSA was mixed with Proteinase K at 37°C for an hour, and subsequently analyzed by SDS-PAGE.


Lane 1. 2 μg of BSA

Lane 2. 16 μg of BSA with 0.01 μg of Proteinase K

Lane 3. 16 μg of BSA with 0.1 μg of Proteinase K

Lane 4. 16 μg of BSA with 1 μg of Proteinase K



LEADSPHERE™ Proteinase K formulation is fine-tuned for direct mixing with and digestion of saliva. LEADSPHERE™ Proteinase K is generated with ISO13485 quality management system specifically for medical devices, and has been thoroughly used in applications to identify viruses, including SARS-CoV-2.



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