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   Technology and Product Development

    Basic Information

Technology developed: Production of Recombinant Human Serum Albumin (rHSA) in E. coli (TP19761966362)
Category: Technology Service/Know how
Details of Inventor(s):
Inventor Institution/Organization/Company Department Designation
Prof. Tapan Chaudhari IIT Delhi Kusuma School Of Biological Sciences Professor
Technical Application Area: Healthcare
If 'Other', please specify:
Please give more details of new technical application area:
Organization(s):
Indian Institute of Technology (IIT) Delhi
Affiliated Ministry: Institution Funding (Self Supported)
Type of technology development: Indigenous
Does the technology help in replacing any import items currently
procured from outside India?
Does the technology have export potential? 1
Category of Technology developed: Immediate Deployment
Stage of Development: Lab-scale
Please describe in detail including the TRL Level:
TRL4

    Abstract:

Applications: HSA has many applications: 1. Treatment of diseases like hypovolemia, shock, burns, blood loss, liver disease, hypoalbuminemia, etc. 2. Drug delivery vehicle for pharma products 3. Excipient for drug formulations/vaccines 4. Biomarker for cancer, rheumatoid arthritis, ischemia, post-menopausal obesity, graft-versus-host disease, monitoring of glycemic control 5. Supplement in cell culture medium 6. Nutrient and stabilizer for various steps involved in cell therapies 7. Biotechnological applications like coatings for medical devices, imaging reagents for X-rays, surgical adhesives/sealants, fusion proteins HSA is mainly produced as fractionated product of collected blood. This is not economical, blood supply is sporadic and collected blood may be contamination by blood-derived pathogens like HIV, hepatitis. Thus, there is need to develop low-cost methods for obtaining animal-free albumin. Host systems such as yeasts, transgenic animals/plants, cell lines have been exploited for production of rHSA and commercial products are available. However, they are generally capital intensive, time consuming and give lower yields. They also have problems like incorrect processing, poor export, hyper-glycosylation, improper folding and need complex downstream processes which add to costs. The invention relates to expression and isolation of rHSA using E. coli host. Production has been enhanced by optimizing parameters like intracellular environment, temperature, induction type and duration, cell lysis conditions, exogenously employed chaperone systems, etc. A simple down-stream process overcoming protein aggregate formation has been developed. The process leads to high yield of functionally active soluble rHSA which has physicochemical and functional properties similar to plasma-derived HSA. It is biocompatible for various applications like supplement for mammalian cell growth, diagnostics, proteomics and lab research purpose.
Advantages: 1. Animal free product and thus no risk of contamination with various blood derived pathogens 2. Not dependent on sporadic and unethical blood supply 3. Various host systems have been exploited for rHSA such as Yeasts like Saccharomyces cerevisiae, Pichia pastoris, Transgenic animals, Transgenic plants esp. rice, Human cell lines. E. coli is the most convenient and well-studied host system as compared to the other host systems. The production is simple, less time consuming and cost effective. The downstream processing is simple which overcomes the problems associated with other systems 4. Biosimilar to the plasma derived HSA in terms of physicochemical and functional properties 5. Biocompatible with various biotechnological applications like supplement to support mammalian cell growth in serum free culture media, diagnostics and proteomics, and for lab research purpose

    Technology Inputs:

Imported Equipment/Spare Parts:
Equipment/Spare Parts Year ITC-HS Code
NA
Indigenous Equipment/Spare Parts:
Equipment/Spare Parts Year ITC-HS Code
NA
Imported Raw Materials:
Raw Materials Year ITC-HS Code
NA
Indigenous Raw Materials:
Raw Materials Year ITC-HS Code
NA
Existing R&D Facilities used:
Facilities Year ITC-HS Code
NA

   Patents & Publications:

Patents:
Filed Patents (No.) Granted Patents (No.) Year
0 0 NA
Publications:
Submitted (No.) Published (No.) Year
0 0 NA

    Commercialization Potential:

Who are the Potential Licensees?
What commercially available products address
the same problem?
Company Product Problem Addressed
Would you like to develop this invention further with
corporate research support?
Yes
Would you be interested in participating in cluster based
programs for commercialization research or business
planning for your invention?
Yes
      Submitted by: Anil Wali Date of Submission: 5-8-2020



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