Valanafusp alfa - ≥98% , CAS No.1815583-32-4

CAS: 1815583-32-4 Cat. No.: V1451378

GRADE & PURITY ≥98%

Storage

Store at -20°C

Shipped In

Ice chest + Ice pads

Übersicht

Valanafusp alfa (AGT-181) is a chimeric monoclonal antibody that fuses human α-L-iduronidase ( IDUA ) and targets the human insulin receptor ( HIR ). Valanafusp alfa has brain penetrating properties, making it useful for research on mucopolysaccharidosis type I (MPS I).

Specifications

Spezifikationen & Reinheit

≥98%

Storage

Store at -20°C

Verschickt in

Ice chest + Ice pads

Dieses Produkt erfordert Kühlkettenversand. Grundversand und andere Economy-Optionen sind nicht verfügbar.

Reinheit

≥98%

Application Protocols

Tested applications and recommended protocols are not provided in the product data for this SKU.

• Validated applications: Not specified for this item; refer to CoA/Spec Sheet.
• Suggested working dilutions: Not specified for this item; refer to CoA/Spec Sheet.
• Positive/negative controls: Not specified for this item; refer to CoA/Spec Sheet.

General guidance (literature/general):

• For cell‑based uptake or activity assays, pre‑cool cells for binding steps when needed, then shift to 37°C for internalization. Wash thoroughly to remove non‑bound protein before measuring intracellular activity.
• For ELISA/SPR/BLI binding assessments, ensure buffer compatibility and include surfactant (0.01% Tween‑20) to reduce non‑specific binding. Calibrate instrument response with appropriate standards.

Please consult the CoA/Spec Sheet or contact technical support for lot‑specific application recommendations.

Biological Roles

Biological context (literature/general):

• Functional composition: Antibody–enzyme fusion proteins combine a targeting antibody with a lysosomal hydrolase, enabling receptor‑mediated uptake and subsequent lysosomal delivery of the enzyme payload.
• Enzyme domain role: Lysosomal hydrolases such as alpha‑L‑iduronidase (IDUA) catabolize glycosaminoglycans (GAGs), including heparan sulfate and dermatan sulfate, within lysosomes. Deficiency of IDUA activity underlies the metabolic disorder mucopolysaccharidosis type I (MPS I); fusion proteins are used to study cellular restoration of catabolic flux in vitro.
• Targeting mechanism: The antibody component is designed to bind a cell‑surface receptor that undergoes endocytosis and transcytosis (e.g., endothelial or epithelial receptors), facilitating uptake of the enzyme domain into cells and potentially across barriers in model systems.
• Trafficking: Following receptor binding, complexes are internalized via clathrin‑mediated endocytosis, trafficked through endosomes, and delivered to lysosomes where the hydrolase becomes active in the acidic milieu.
• Assay readouts: Cellular GAG content, lysosomal size/number (LAMP1/2 staining), and enzyme activity assays serve as proxies for functional delivery.

Notes for this item: Specific target receptor, kinetic parameters, and activity values are not provided in the product data for this SKU. Refer to the CoA/Spec Sheet for any available lot‑specific biological characterization.

Buffer Applications

This product is a protein reagent and is typically used in buffered aqueous systems rather than as a buffer component.

General/literature guidance for preparing working solutions (not item specifications):

• Common working buffers: 1× PBS (pH 7.2–7.4), 10–20 mM histidine (pH 6.0–6.5) with 100–150 mM NaCl, or 20–50 mM sodium phosphate (pH 6.5–7.4). Include 2–10% trehalose or sucrose and 0.01–0.02% polysorbate‑20/80 when freezing or for stress mitigation.
• Protein stabilization: Add 0.1% human serum albumin (HSA) or BSA to reduce adsorption to plastics during low‑concentration handling, if compatible with downstream assays.
• Filtration: Sterile‑filter through 0.22 µm PVDF or PES if aseptic conditions are required. Avoid cellulose acetate for surfactant‑containing formulations.
• pH/ionic strength: Maintain near‑neutral pH and isotonic ionic strength to preserve structural integrity and activity of antibody fusions.

Not typically applicable: This product does not serve as a buffering agent; instead, select a buffer system that supports the stability of the fusion protein and the requirements of your bioassay. Item‑specific formulation details are not provided in the product data.

Green Alternatives

Green chemistry consideration is not directly applicable to a protein biologic in the same way as for small‑molecule solvents or reagents. Nevertheless, you can improve environmental performance by focusing on formulation, handling, and process choices.

General/literature guidance for greener practice with protein reagents:

• Solvent avoidance: Conduct all work in aqueous buffers; avoid organic co‑solvents where possible to reduce VOCs and hazardous waste.
• Buffer selection: Choose phosphate, citrate, or histidine buffers prepared from benign salts; avoid buffers requiring toxic counterions.
• Process scale: Miniaturize assays (microplates, microfluidics) to reduce material consumption and biohazard waste.
• Cold-chain efficiency: Consolidate shipments and select insulated shippers with reusable ice packs to lower transport footprint.
• Cleaning: Prefer enzymatic detergents over harsh organic solvents for decontamination of equipment exposed to proteins.

Comparison (qualitative):

• Aqueous buffers vs. mixed organic systems: Aqueous systems minimize flammability, toxicity, and waste treatment burdens, with the primary tradeoff being microbial contamination risk (mitigated by sterile technique and preservatives compatible with the assay).

Item-specific greener alternatives are not applicable; this SKU is itself a biologic prepared for research use.

Pharmaceutical Uses

No clinical or therapeutic claims are made for this product. It is supplied strictly for research use only.

Formulation/manufacturing context (literature/general):

• Biologic formulations of antibody–enzyme fusions often employ histidine or phosphate buffers at near‑neutral pH, isotonic NaCl, non‑ionic surfactants (polysorbate‑20/80) to limit interfacial stress, and disaccharides (sucrose/trehalose) as cryo‑/lyoprotectants.
• Container/closure: Low‑binding Type I glass vials with siliconized stoppers are commonly used to mitigate adsorption and leachables; polypropylene low‑bind plastics are appropriate for working aliquots.
• Quality attributes monitored include potency (enzyme activity), purity/aggregates (SEC), identity (peptide mapping), and safety (endotoxin, bioburden). These are general considerations; item‑specific targets are not provided.
• Pharmacopeial status: No pharmacopeial monograph is implied for this SKU. Any GMP/clinical suitability is not claimed.

Important: This SKU is labeled “For research use only.” It is not intended for diagnostic procedures, therapeutic administration, or human/animal consumption. Refer to institutional guidelines for handling investigational biologics in preclinical labs.

Physical Properties

Item-specific physical specifications are not provided in the product data for this biologic. Proteins do not have conventional small‑molecule constants such as boiling point or logP.

Item-specific values:

• Appearance: Not specified for this item; refer to CoA/Spec Sheet.
• Concentration/formulation: Not specified for this item; refer to CoA/Spec Sheet.
• pH (formulation): Not specified for this item; refer to CoA/Spec Sheet.
• Extinction coefficient (A280): Not specified for this item; refer to CoA/Spec Sheet.

General/literature guidance for protein fusion reagents (not item specifications):

• Physical state: Supplied either as a frozen liquid or lyophilized powder; reconstitution typically in isotonic buffer (e.g., PBS) at neutral pH.
• Solubility: Readily soluble in aqueous buffers; insoluble in most organic solvents.
• Stability considerations: Sensitive to repeated freeze–thaw; stability enhanced by carrier protein (e.g., 0.1% HSA) or stabilizers (e.g., trehalose) and storage at ≤ −20°C.
• Isoelectric point (pI): Fusion proteins based on human IgG1 often exhibit pI in the 7–9 range, but actual pI is sequence/formulation dependent (not specified for this item).
• Viscosity/aggregation: Concentrated protein solutions can be viscous and aggregation‑prone; avoid vigorous agitation and maintain low temperature.

Please consult the CoA/Spec Sheet for any lot‑specific physicochemical details.

Quality and Grades

Item-specific grade, purity, and analytical specifications are not provided in the product data for this SKU.

• Grade/purity: Not specified for this item; refer to CoA/Spec Sheet.
• Stabilizers/excipients: Not specified for this item; refer to CoA/Spec Sheet.

General notes on quality for recombinant fusion proteins (literature/general):

• Identity confirmation typically employs intact mass analysis, peptide mapping by LC–MS/MS, and non‑reducing/reducing SDS‑PAGE to verify expected chain composition and disulfide patterns.
• Purity is often reported as % monomer by SEC‑HPLC and % purity by SDS‑PAGE; low aggregate levels are important for reproducible activity.
• Glycosylation profile (if applicable) can be characterized by released N‑glycan mapping or intact glycoform distribution; lot‑to‑lot control supports consistent performance.
• Endotoxin: For cell‑based work, ≤1 EU/µg (or tighter) is typically desired, measured by LAL; actual limit is not specified for this item.
• Bioburden/sterility: Many protein reagents are sterile‑filtered (0.2 µm) and filled aseptically; status not specified for this item.

Interpretation of common grades (context):

• Research grade indicates suitability for laboratory studies but not for diagnostic or therapeutic use. Heterologous host‑cell proteins/DNA may be present at trace levels unless specified.

Please consult the CoA/Spec Sheet for definitive grade, purity, and analytical test results for this product.

Reaction and Applications

This product is a biologic reagent (fusion protein) and is not typically used as a stoichiometric reagent/solvent in classical organic reactions. However, it has valuable research applications in protein/cell systems.

Research application contexts (literature/general):

• Blood–brain barrier (BBB) transport studies: Antibody–enzyme fusion proteins are used to evaluate receptor‑mediated transcytosis (RMT) across BBB models (e.g., endothelial cell monolayers), quantifying uptake, transcytosis, and intracellular trafficking.
• Enzymology assays: The enzyme domain (lysosomal hydrolase class) can be characterized for specific activity using fluorogenic glycosaminoglycan mimetics; activity measured in MU/mg or U/mg. Exact substrate and unit definition are assay‑dependent and not specified for this item.
• Cell uptake/internalization: Flow cytometry or confocal microscopy with tagged secondary antibodies can measure receptor‑dependent internalization in cell lines expressing the cognate receptor.
• Pharmacokinetic modeling (in vitro): Binding kinetics (e.g., SPR, BLI) to the receptor ectodomain and activity retention can be profiled to inform transport and turnover models.
• Lysosomal delivery readouts: In cell models that accumulate glycosaminoglycans, enzyme fusions are evaluated for reduction of storage material; quantify by DMMB dye or LC–MS disaccharide profiling.

Practical considerations (general):

• Use low‑protein‑binding plastics and include carrier protein to minimize adsorption.
• Keep on ice during setup; avoid >2–3 freeze–thaw cycles.
• For kinetic binding assays, filter/degass buffers, and confirm monodispersity by SEC or DLS beforehand.

No manufacturer‑specific application notes are provided in the product data for this SKU.

Reaction Conditions

Classical reaction condition tables (solvent, temperature, catalysts) are not applicable to this biologic reagent.

General/literature guidance for use in bioassays (not item specifications):

• Working concentration: Determined empirically by assay; common ranges for receptor‑binding or cellular uptake studies are 0.1–100 nM. For enzyme activity add‑back in cells, typical mass loadings span 0.1–10 µg/mL depending on cell type and duration.
• Temperature: Maintain samples on ice during setup; perform incubations at 4°C for binding‑only assays or 37°C for internalization/activity assays.
• Incubation times: 15–60 min for binding, 1–24 h for uptake and lysosomal delivery readouts.
• Buffer: Neutral pH, isotonic buffers (PBS, HBSS, complete culture media) compatible with the target cells and detection method.
• Controls: Include isotype control or non‑binding fusion protein, excess unlabeled competitor for specificity assessment, and heat‑inactivated enzyme as a negative control for activity readouts.

Expected outcomes and yields: Not applicable. Please refer to your assay SOPs and validate conditions with pilot experiments. No item‑specific activity units or kinetics are provided in the product data.

Safety and Handling

Safety data specific to this item are not provided in the product data.

GHS/labeling for this item:

• Signal word: Not specified for this item; refer to SDS.
• H‑statements: Not specified for this item; refer to SDS.
• GHS classification/pictograms: Not specified for this item; refer to SDS.

General laboratory safety guidance for recombinant proteins (literature/general):

• PPE: Wear lab coat, nitrile gloves, and safety glasses. Handle in a clean area to prevent microbial contamination.
• Biosafety: Treat as a non‑hazardous protein reagent for research use; implement standard BSL‑1 practices unless your application dictates otherwise.
• Avoid aerosol generation and inhalation; prevent contact with skin and eyes.
• Incompatibilities: Avoid strong oxidizers and extremes of pH or temperature which can denature the protein.
• Peroxides/polymerization: Not applicable.

First‑aid overview (general):

• Skin/eye contact: Rinse with water for at least 15 minutes. Remove contaminated clothing.
• Inhalation: Move to fresh air. Seek medical attention if symptoms occur.
• Ingestion: Rinse mouth; seek medical advice if unwell.

Disposal: Follow institutional guidelines for protein/biologic waste; do not release to drains. Always defer to the product SDS for authoritative safety information.

Solvent Selection

As a recombinant protein, Valanafusp alfa is handled in aqueous buffers rather than organic solvents.

Item-specific formulation guidance:

• Supplied solvent/buffer: Not specified for this item; refer to CoA/Spec Sheet.
• Recommended diluent: Typically sterile, neutral pH buffers (e.g., PBS, 1× DPBS, or 10–50 mM histidine) with 100–150 mM NaCl. Include 0.01–0.1% carrier protein (HSA/BSA) if non‑specific adsorption is a concern (general guidance).

General buffer selection considerations (literature/general):

• pH control: Maintain near enzyme/antibody stability optima (commonly pH 6.0–7.4 for IgG‑based fusions); avoid extremes that promote denaturation or deamidation.
• Ionic strength: 100–200 mM NaCl helps minimize aggregation and non‑specific binding.
• Excipients: Trehalose or sucrose (2–10%) and polysorbate‑20/80 (0.01–0.02%) are commonly used to stabilize proteins during freezing/thawing and agitation. Confirm compatibility with your assay.
• Avoid: Alcohols, acetone, chloroform, DMSO at high percentages—these denature proteins. If small volumes of organic co‑solvent are unavoidable in assays, keep below 5% v/v and verify activity.

Comparison (general):

• PBS vs. Tris: PBS offers isotonicity and broad compatibility; Tris provides strong buffering near pH 7–9 but can interact with some conjugation chemistries.
• Histidine buffers (pH ~6): Often favored for formulation stability of IgG fusions.

Always match the buffer system to the intended bioassay and avoid chelators/detergents that may affect enzyme or receptor interactions unless required.

Storage and Reconstitution

Item-specific instructions provided:

• Storage conditions: Store at −20°C.
• Shipped in: Ice chest + ice pads.

Additional handling guidance (general/literature; not item specifications):

• Upon receipt: Verify container integrity. If supplied frozen, keep at −20°C or colder until use. If lyophilized, allow vial to equilibrate to room temperature before opening to minimize moisture condensation.
• Reconstitution (if lyophilized): Gently add sterile buffer (e.g., PBS or 10–20 mM histidine, pH 6.5–7.4) to the desired concentration. Avoid vigorous vortexing; gently invert or roll to dissolve. Optional: include 0.1% HSA/BSA to minimize adsorption at low concentrations.
• Aliquoting: Prepare single‑use aliquots in low‑bind tubes to avoid repeated freeze–thaw. Flash‑freeze in a dry‑ice/ethanol bath or liquid nitrogen and store at −80°C for long‑term stability when compatible; otherwise keep at −20°C per item label.
• Freeze–thaw: Limit to ≤2–3 cycles. Thaw on ice and mix gently. Do not refreeze thawed working solutions unless stability is documented for your assay.
• Light/shear: Protect from strong light and mechanical agitation (no vigorous pipetting/foaming).

Appearance, concentration, formulation components, and stability window after thaw are not specified for this item; consult the CoA/Spec Sheet for lot‑specific guidance.

Research use note: For research use only.

Structure and Identity

Brief overview: Valanafusp alfa is a recombinant biologic (antibody–enzyme fusion protein). Item-specific structural identifiers are not provided in the product data; protein/biologic entities do not have SMILES/InChIKeys in the conventional small‑molecule sense.

• SKU: V1451378
• Product name: Valanafusp alfa
• CAS: 1815583-32-4
• Category: 小分子和化合物库 (listing category); functionally, this product is a large-molecule biologic (fusion protein)
• Molecular formula: Not specified for this item; refer to CoA/Spec Sheet.
• Molecular weight: Not specified for this item; refer to CoA/Spec Sheet.
• SMILES / InChI / InChIKey: Not applicable for proteins; not specified for this item.

Structural features (literature/general description):

• Fusion architecture: an antibody domain genetically fused to a lysosomal hydrolase domain (antibody–enzyme fusion).
• Typical elements in such fusions include: two heavy and two light chains (IgG scaffold) with N-linked glycosylation sites, and a C‑terminal or N‑terminal enzymatic polypeptide chain.
• Functional groups (at the biopolymer level): peptide backbone (amide bonds), disulfide bridges (cysteines), carbohydrate glycans (if glycosylated), and post‑translational modifications typical of CHO‑expressed biologics.

2D/primary-structure description (literature/general):

• Primary sequence comprises immunoglobulin variable and constant domains plus the enzyme sequence; higher-order structure includes IgG Fab/Fc folds and a folded enzyme domain. Exact sequence and domain boundaries are not specified for this item.

Synthetic Utility

Not typically applicable. Valanafusp alfa is a recombinant protein reagent and is not employed as a synthetic intermediate or reagent in small‑molecule chemistry.

General protein engineering context (literature/general):

• In bioconjugation workflows, antibody–enzyme fusions can be further modified (e.g., site‑selective PEGylation, fluorescent labeling) using lysine‑ or cysteine‑targeted chemistries. Such modifications require careful control to preserve binding and enzymatic activity.
• Analytical characterization after any user‑performed modification typically includes SEC‑HPLC (aggregate content), SDS‑PAGE (apparent mass), enzyme activity assay (potency retention), and binding assay (SPR/BLI or ELISA).

For chemical synthesis or catalysis, consider appropriate small‑molecule catalysts or enzymes tailored to the desired transformation; this biologic is not designed for that purpose.

Target Specificity

Item-specific target and binding characteristics are not provided in the product data for this SKU.

• Antigen/target: Not specified for this item; refer to CoA/Spec Sheet.
• Epitope/affinity: Not specified for this item; refer to CoA/Spec Sheet.
• Species reactivity: Not specified for this item; refer to CoA/Spec Sheet.
• Clone/isotype: Not specified for this item; refer to CoA/Spec Sheet.

Note: Target specificity information is only reported when explicitly provided in the product documentation. None is available here.