Pure Solutions

Pure provides solutions. Whether it’s creating therapeutics for immunotherapy, pioneering an approach to producing highly purified forms of HLA proteins, or developing vaccines for combating cancer, we’re leading the way to harnessing the power of the human immune system.

Pure Protein

Superior scale, yield, and purity.

Pure Protein has pioneered an approach to produce soluble forms of HLA Class I and Class II proteins (sHLA). Only Pure can make significant quantities of this highly purified and naturally processed product. These endogenously loaded, naturally glycosylated proteins can be used for critical research and in the development of a variety of diagnostics and therapeutics needed for immunotherapy applications.

Pure sHLA proteins provide superior scale, yield, and purity over other products. The genetic compositions and production methods and uses, including antibody removal strategies, are protected by a series of issued and pending patents that secure Pure Protein with a solid IP position.


Superior Qualities of Pure sHLA

Purity and Identity

Pure sHLAs are:

  • far more pure (>95%) than competing detergent lysate (DCL) products, so pure that human injectable cGMP production is initial planning
  • compatible with standard Quality Control testing (Release, Lot variability, and Stability testing)
  • Pure Protein determines the purity and identity of highly homologous HLA proteins using LC-MS the same standard as use for injectable products
  • competing detergent lysate (DCL) products are heterogeneous thus not amicable to FDA standards of GMP production or even accurate quantitation

Integrity, Strength, and Potency

  • Pure Protein has developed proprietary assays for determining the potency
  • In comparative assays to determine the presence of denatured HLA proteins, Pure sHLA is consistently and significantly more intact that competitor protein
  • Pure has developed method to remove denatured sHLA proteins from a batch, rendering the product 100% fully conformationally intact

Functionality

  • On an allele-to-allele basis, Pure sHLAs consistently have lower false positives than the competitors due to less denatured protein

Performance

  • Experience and Know-How related to production and assay development
  • Pure sHLAs are adaptable to GLP and cGMP production standards
  • Pure has >220 different sHLA proteins representing all major classes: A, B, C, DR, DQ, DP. This is more than any other competitor
  • Soluble HLAs can provide HLA availability in response to new clinical/market needs

Mammalian-derived

  • Pure sHLA are naturally glycosylated and loaded with the full repertoire of ~10,000 endogenous peptide ligands unlike HLA production in bacterial and insect systems
  • Additional processing is required to “humanize” the HLA products from non-mammalian proteins which are inadequate for applications in transplant

Sole Supplier of natural Class II proteins

  • After 10 years of research, Pure secreted the first ever class II HLA protein from a mammalian cell
  • No other research or commercial group has been able to enable class II HLA secretion in mammalian cells despite 2 decades of documented attempts
  • Class II HLAs have become of increasingly more interest as they’ve now been linked to many important disease pathologies

Feature

Competitors

Pure sHLA

Release Specifications

Cell line identity - single specificity

Identity by LC/MS and ESI-MS/MS

Purity < 70%

Purity > 95%

Potency – Serologic reactivity

Potency – Serologic reactivity

Quantitation – N/A

Quantitation – BCA

Lot-to-Lot Variability

Up to 300%

0%

Stability

Variable

Up to 10 Years

Regulatory Standard

GLP only

GLP and GMP

Scale

Low volume production

High volume production

Coupling to a solid support matrix

Poorly amenable to coupling strategies

Multiple effective coupling strategies used (both licensed and proprietary)


Pure Product List

Pure has the ability to isolate Anti-HLA antibodies to specific sHLA alleles from either client-provided patient sera.

  • sHLA (Class I and II) – Recombinant Soluble HLA proteins identical to natural HLA proteins
  • sHLA SMX – sHLA coupled to Sepharose matrix for polyclonal antibody depletion and recovery
  • sHLA Bio – sHLA proteins coupled with biotin for bead assays
  • sHLA FITC – sHLA proteins labeled with FITC fluorochrome
  • sHLA PE – sHLA proteins labeled with PE fluorochrome
  • sHLA Blocker – sHLA single antigens for specific blocking of anti-HLA antibodies in diagnostic tests.


Pure has the ability to isolate Anti-HLA antibodies to specific sHLA alleles from either client-provided patient sera. Please see Pure's Corporate Services for more detail.