OPKO Biologics
OPKO Biologics is a research-based biologics drug development company with a proven track record of developing bio-better, long-acting versions of therapeutic proteins and peptide drug candidates. It operates state-of-the-art facilities in Israel, focusing on innovative technologies such as CTP, reversible PEGylation, and stabilizer-based technologies. The company is committed to improving healthcare outcomes through advanced drug development and has a comprehensive pipeline of products in various stages of clinical development.
Industries
Nr. of Employees
medium (51-250)
OPKO Biologics
Kiryat Gat, HaDarom, Israel, Asia
Products
NGENLA (somatrogon)
A long-acting recombinant human growth hormone designed for once-weekly subcutaneous administration to treat growth hormone deficiency in children and adolescents; received marketing authorizations in multiple regions.
Long-acting Factor VIIa (MOD-5014)
A long-acting recombinant Factor VIIa designed to extend circulatory half-life for treatment and prevention of bleeding episodes in hemophilia A and B, intended to enable prophylactic use.
Long-acting hGH antagonist (OPK-8801001)
A long-acting human growth hormone antagonist under development using stabilizer-based technology to extend serum half-life and reduce injection frequency for treatment of acromegaly.
Long-acting PTH (OPK-8801004)
A long-acting parathyroid hormone candidate developed using stabilizer-based technology for the treatment of hypoparathyroidism, aiming for once-weekly administration.
Long-acting IGF-1 candidate (OPK-8801002)
An extended-release IGF-1 repletion therapy in development using stabilizer-based technology for the treatment of severe primary IGF-1 deficiency (SPIGFD).
NGENLA (somatrogon)
A long-acting recombinant human growth hormone designed for once-weekly subcutaneous administration to treat growth hormone deficiency in children and adolescents; received marketing authorizations in multiple regions.
Long-acting Factor VIIa (MOD-5014)
A long-acting recombinant Factor VIIa designed to extend circulatory half-life for treatment and prevention of bleeding episodes in hemophilia A and B, intended to enable prophylactic use.
Long-acting hGH antagonist (OPK-8801001)
A long-acting human growth hormone antagonist under development using stabilizer-based technology to extend serum half-life and reduce injection frequency for treatment of acromegaly.
Long-acting PTH (OPK-8801004)
A long-acting parathyroid hormone candidate developed using stabilizer-based technology for the treatment of hypoparathyroidism, aiming for once-weekly administration.
Long-acting IGF-1 candidate (OPK-8801002)
An extended-release IGF-1 repletion therapy in development using stabilizer-based technology for the treatment of severe primary IGF-1 deficiency (SPIGFD).
Services
CMC development services for proteins and peptides
Process development, formulation, analytical development, stability studies, and GMP-capable QC release for clinical-stage biologics.
Preclinical pharmacology and toxicology services
In vivo and in vitro proof-of-concept, potency, efficacy, binding affinity and safety studies to support IND-enabling packages.
GLP bioanalytical services (PK and immunogenicity)
Development, validation and execution of GLP-compliant bioanalytical assays including sample receipt, analysis and archiving.
Clinical development and operations management
Clinical trial setup, site identification and qualification, KOL engagement, CRO/vendor oversight and global trial management under GDP and GCP.
QA and regulatory support
Quality management system implementation, audit programs, supplier qualification, equipment validation and support for regulatory inspections.
CMC development services for proteins and peptides
Process development, formulation, analytical development, stability studies, and GMP-capable QC release for clinical-stage biologics.
Preclinical pharmacology and toxicology services
In vivo and in vitro proof-of-concept, potency, efficacy, binding affinity and safety studies to support IND-enabling packages.
GLP bioanalytical services (PK and immunogenicity)
Development, validation and execution of GLP-compliant bioanalytical assays including sample receipt, analysis and archiving.
Clinical development and operations management
Clinical trial setup, site identification and qualification, KOL engagement, CRO/vendor oversight and global trial management under GDP and GCP.
QA and regulatory support
Quality management system implementation, audit programs, supplier qualification, equipment validation and support for regulatory inspections.
Expertise Areas
- CMC development for biologics
- Preclinical pharmacology and toxicology
- GLP bioanalytical method development and validation
- Clinical trial operations and CRO management
Key Technologies
- CTP-based half-life extension (C-terminal peptide fusion)
- Reversible PEGylation with hydrolysable linker
- Stabilizer-based reversible protein binding
- Recombinant protein expression (bacterial and mammalian)