CALL FOR TECHNOLOGY TRANSFER – EXPRESSION OF INTEREST (EOI)

Isolation and purification of Plasma proteins -Fibrinogen, Thrombin, Intravenous Immunoglobulin, Albumin

Intended end use :
Fibrinogen and Thrombin: Haemostasis, Surgical Sealant, regenerative medicine

Albumin: Intravenous infusions, Albumin is used to replace blood volume loss resulting from trauma such as a severe burns or an injury that causes blood loss, albumin deprivation in liver diseases and cancer.

IVIG: Two main uses for IVIG are as replacement therapy in primary or acquired antibody deficiency disorders and as immunomodulatory agents in patients with autoimmune or inflammatory conditions.
In Neurology: Demyelinating neuropathy

Product description : (The "small pool" plasma fractionation is designed for sequential isolation of products; Economic production requires all 3 products from same raw material, in the same class 100 facility)
Plasma Proteins Fibrinogen and thrombin isolated from human plasma at small scale fibrinogen concentration 40-60mg/ml and thrombin 150-250IU/ml

Fibrinogen Concentrate: from cryoprecipitate collected using continuous flow centrifugation; Thrombin by ion exchange chromatography from 1L

Know how for Albumin: Ion exchange chromatography;
IVIG: Ion exchange chromatography

Novelty(please specify patents if any filed) : Indian patent granted in 2024 for all the products for sequential fractionation process for small pool plasma. Patent filed on 06/07/2016, granted on 29/11/2023

Current Development stage/ Evaluations done :
TRL3
Evaluations done:
Fibrinogen & thrombin: purity yield
Albumin: Tests (biochemical), purity yield
IVIG: Tests (biochemical), purity yield

Industry responsibility for technology transfer :
# Pending evaluations – All characterizations needed for qualifying the product for human use (Class D)
# Sourcing of blood plasma - The technology offered is only for small scale production using plasma from local blood banks to avoid plasma transportation
# Setting up the GMP facility
# Scaling up and validation
# Preclinical evaluation, Clinical evaluation, Regulatory approvals
# Packaging and sterilization

Deliverables from Institute : Know – how of 1 L batches – Technology Transfer document and linkages for specialized third party processes for continuous flow centrifuge, ion exchange chromatography and on the process of isolation.