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CRO technical services

Clinical samples

Biohubx has extensive experience in obtaining clinical samples from institutions and healthcare facilities for study analysis and validation. Examples of samples acquired for study analysis include heat inactivated COVID-19 samples, blood, and mammalian cells.

Biomaterials

There is a plethora of testing associated with biomaterials and Biohubx has in house scientists to assist with these testing requests. Testing expertise includes:
  • biocompatibility and cytotoxicity
  • blood compatibility
  • biodegradable biomaterial assessment
  • physico-chemical morphological and topographical characterization

Nanomaterials

Nanomaterials are an innovative approach within the medical device community. We can provide biocompatibility and blood compatibility testing of your novel technology.

Sterilization and validation

Sterilization is an integral step in the preparation of a medical device for clinical usage. We offer extensive expertise in the area of sterilization and validation of these related procedures.
  • In this area we offer bioburden sterilization assessment (microbial and biological fluid).
  • We can also assist in the development of Instructions for Use (IFU) of your device for sterilization procedures.

Microbial

  • We offer high throughput testing services to assess the efficacy of your novel antimicrobial or biomaterial against nosocomial and community pathogens.
  • We also offer expertise in working with anaerobic bacteria and biofilms.

In Vitro Skin Irritation

Reconstructed human epidermis test methods performed as per ISO 10993-23 (2021), OECD 439. This allows more work to be assessed in vitro on skin irritation before moving to further testing.

Cell growth, expansion, and analysis

Mammalian cells can be grown, maintained, and expanded within our facilities to create stocks within a biobank. Molecular and protein analysis of these cells in response to various challenges can also be performed.

Storage

Bacterial and mammalian cell stocks can be stored long term in our -80C freezer. Reagents and laboratory consumables can also be stored in out -30C freezer and +4 C fridge.

Independent assay validation

We can perform independent validation of various assay types as per regulatory body requirements. Examples of tests that can be performed include limit of detection (LOD) and interference tests.

Protocol review

Biohubx offers extensive and comprehensive review of protocols for testing to be performed at the laboratory facility. All protocols are compared with relevant regulatory standards and improvements can be suggested. Lead time for review of protocols and feedback is estimated at 3 business days.