Oprelvekin API is a recombinant form of human interleukin-11 (IL-11), a cytokine belonging to the interleukin family and associated with hematopoietic growth and platelet production. Unlike conventional chemically synthesized small-molecule APIs, Oprelvekin is a recombinant protein produced using biotechnology. FDA and PubChem records identify Oprelvekin as recombinant human interleukin-11 produced through recombinant DNA technology in Escherichia coli. The protein is non-glycosylated and has a molecular mass of approximately 19,000 daltons.
Oprelvekin is also known by the development and product names associated with recombinant interleukin-11, including recombinant human IL-11, rhIL-11, Neumega, and 2-178-Interleukin 11. Its CAS Registry Number is 145941-26-0, while its FDA Unique Ingredient Identifier (UNII) is HM5641GA6F.
Oprelvekin is structurally different from conventional pharmaceutical compounds because it is a biologically produced protein rather than a small organic molecule. The recombinant protein contains 177 amino acids, whereas naturally occurring human IL-11 contains 178 amino acids. Publicly available protein databases report a calculated molecular weight of approximately 19,047.2 Da, while regulatory and pharmaceutical references commonly describe its molecular mass as approximately 19 kDa.
Because Oprelvekin is a recombinant protein API, quality assessment requires biological and physicochemical characterization appropriate for biopharmaceutical products. Important quality attributes can include protein identity, molecular mass, purity, aggregation profile, biological activity, host-cell-derived impurities, residual host-cell DNA, microbial quality, endotoxin and other process-related impurities. Numerical acceptance limits for these attributes should be taken from the applicable manufacturer or approved product specification rather than assumed from small-molecule API standards.
Oprelvekin acts as a recombinant form of human interleukin-11 and interacts with the IL-11 receptor pathway. Its pharmacological activity is associated with stimulation of hematopoietic stem cells and megakaryocyte progenitor cells, followed by megakaryocyte maturation and increased platelet production. This biological activity explains its classification as a megakaryocyte growth factor and interleukin. PubChem lists Oprelvekin under ATC code L03AC02.
The historical U.S. product Neumega (oprelvekin) received FDA marketing approval on November 25, 1997. FDA's orphan-drug database identifies the approved indication as prevention of severe thrombocytopenia associated with myelosuppressive chemotherapy.
The FDA Purple Book records Neumega as a 5 mg single-dose vial for injection administered subcutaneously, under BLA 103694. The FDA record also indicates that the product's U.S. licensure status is discontinued.
For an Oprelvekin API manufacturer in India, manufacturing controls are particularly important because recombinant proteins require carefully controlled upstream and downstream processing. Production involves a recombinant biological expression system rather than conventional chemical synthesis. Historical Oprelvekin documentation identifies E. coli as the production organism.
A robust Oprelvekin API quality program can include control of raw materials, recombinant cell-bank characterization, fermentation or cultivation parameters, harvest processing, purification, viral/microbial and bioburden controls where applicable, endotoxin management, protein concentration, identity testing, purity assessment and biological potency testing.
For biotechnology-derived APIs, the analytical package is normally more extensive than the specification set used for a conventional small molecule. Techniques such as peptide mapping, chromatographic purity testing, electrophoretic analysis, mass spectrometry, protein concentration determination and cell-based biological assays may be incorporated according to the product's validated control strategy.
Oprelvekin has pharmaceutical relevance primarily because of its thrombopoietic biological activity. It has historically been used for prevention of severe chemotherapy-associated thrombocytopenia and reduction of platelet transfusion requirements in appropriate patients.
For pharmaceutical development, Oprelvekin recombinant protein API, recombinant human interleukin-11, and rhIL-11 are relevant search terms for organizations researching cytokine-based therapies, hematopoietic growth factors and recombinant protein technologies.
Oprelvekin should not be evaluated using a conventional small-molecule specification template. FDA/PubChem records identify it as a recombinant, non-glycosylated protein of approximately 19 kDa.
Consequently, attributes such as molecular identity, protein purity, aggregation, charge characteristics, biological potency and process-related impurities are generally more meaningful for evaluating the quality of recombinant Oprelvekin API than parameters such as melting point or conventional loss-on-drying specifications.
This distinction is important when preparing technical documentation, regulatory dossiers, API specifications and pharmaceutical development information for Oprelvekin. Where a universal numerical pharmacopoeial limit is not established, the specification should be identified as product-specific rather than assigning an unsupported numerical value.
Oprelvekin represents a specialized category of recombinant protein API within the biopharmaceutical industry. Its production and quality control require expertise in recombinant expression, purification, protein characterization and biological activity testing.
For pharmaceutical and biotechnology applications, accurate identification is essential. The principal identifiers include Oprelvekin, recombinant human interleukin-11, CAS 145941-26-0, and UNII HM5641GA6F.
Organizations evaluating Oprelvekin API should consider the complete technical package, including identity, purity, potency, molecular characterization, manufacturing process controls, storage conditions and applicable regulatory documentation. Because Oprelvekin is a biological protein rather than a conventional synthetic compound, its quality specifications should always be aligned with the validated product-specific control strategy.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.2% |
| Individual Impurity | NMT 0.10% |
| Total Impurities | NMT 0.50% |
| Water Content | NMT 0.5% |