Making NV-387

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!!Step 1: Synthesize the Polymer Backbone What: Create a water-soluble, biodegradable polymer chain (e.g., PEG-based block copolymer). How: Use controlled chemical reactions (e.g., ring-opening polymerization). Equipment: * Jacketed glass or stainless-steel reactor (with temperature control, stirrer, and nitrogen inlet). * Condenser and addition funnel for controlled reagent dosing. 🔍 Search term: “chemical reactor for polymer synthesis GMP” !!Step 2: Attach Virus-Targeting Ligands What: Chemically link specific ligands (e.g., peptides that mimic host receptors for orthopoxviruses) to the polymer. How: Use coupling chemistry (e.g., NHS-ester or click chemistry) in a solvent system. Equipment: * Same stirred reactor as above, with precise pH/temperature control. * In-line analytics (optional): FTIR or Raman probe to monitor reaction progress. 🔍 Search term: “peptide-polymer conjugation reactor” !!Step 3: Purify the Conjugate What: Remove unreacted ligands, solvents, and byproducts. How: Dialysis or filtration against clean buffer. Equipment: * Tangential Flow Filtration (TFF) system – most common in GMP manufacturing. Uses hollow-fiber membranes to separate large polymer-ligand conjugates from small impurities. 🔍 Search term: “TFF system for nanoparticle purification” !!Step 4: Form Nanoparticles (Self-Assembly) What: Trigger the polymer-ligand conjugates to form micelles (~20–50 nm) in water. How: Add purified conjugate to aqueous buffer under gentle mixing—micelles form spontaneously. Optional: Use controlled mixing for uniform size. Equipment: Static mixer or microfluidic nanoparticle assembler (for tighter size control). 🔍 Search term: “nanoparticle self-assembly mixer” or “microfluidic mixer for micelles” !!Step 5: Sterile Filtration & Fill What: Ensure the solution is sterile and ready for lyophilization. How: Pass through a 0.22-micron filter into sterile vials. Equipment: * Sterile filtration unit (in ISO Class 5 cleanroom). * Aseptic filling machine (for clinical batches). 🔍 Search term: “sterile filtration system pharmaceutical” !!Step 6: Lyophilization (Freeze-Drying) What: Convert liquid drug into stable powder for long-term storage. How: Freeze solution, then remove water by sublimation under vacuum. Equipment: * Industrial lyophilizer (freeze-dryer) with shelves, vacuum pump, and condenser. 🔍 Search term: “pharmaceutical lyophilizer GMP” !!Step 7: Quality Control Testing Tests include: * Particle size: Dynamic Light Scattering (DLS) instrument * Purity: HPLC or UPLC system * Sterility & endotoxins: LAL test kit, microbial culture * Identity: NMR or mass spectrometry (at development stage) 🔍 Search term: “DLS nanoparticle analyzer Malvern” {pre} [Polymer Synthesis] ↓ [Ligand Conjugation] ↓ [Purification (TFF)] ↓ [Nanoparticle Self-Assembly] ↓ [Sterile Filtration] ↓ [Lyophilization → Final Powder] ↓ [QC Testing → Release] {/pre}
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