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| Product Name | GMP-Grade Oligonucleotide Synthesis Service for Therapeutic Development |
| Catalog No. | PRIPRO-0025 |
| Description | A Good Manufacturing Practice (GMP)-compliant oligonucleotide synthesis service producing primers, probes, and therapeutic oligonucleotides under full GMP conditions for use in clinical trials and commercial pharmaceutical products. This service manufactures oligonucleotides in dedicated, environmentally controlled cleanroom suites (ISO Class 7/Class 8) with full material and personnel flow segregation. The GMP system encompasses vendor qualification for all raw materials, validated synthesis and purification processes, in-process controls at critical steps, comprehensive release testing against approved specifications, and stability testing per ICH guidelines. Each batch is released by a Qualified Person (QP) with a GMP certificate of analysis and certificate of conformance. The service is designed for oligonucleotide-based therapeutics including antisense oligonucleotides (ASOs), siRNA drug substance, aptamer therapeutics, and DNA/RNA components of gene therapy products. Scales range from preclinical (gram) to clinical and commercial (kilogram) quantities. |
| Intended Use | Designed as an active pharmaceutical ingredient (API) or critical raw material for oligonucleotide-based therapeutics including antisense oligonucleotides (ASOs), small interfering RNA (siRNA) drug substances, therapeutic aptamers, splice-switching oligos, immunostimulatory CpG oligonucleotides, and starting materials for mRNA vaccine production (DNA template). Suitable for preclinical toxicology studies, Phase I–III clinical trial material, and commercial product manufacturing. |
| Principle / Technology | Solid-phase phosphoramidite synthesis under full GMP (ICH Q7) with validated process parameters; all critical process parameters (CPPs) identified and controlled within proven acceptable ranges; dedicated or campaign-segregated manufacturing suites with validated cleaning procedures |
| Detection Method | Validated HPLC purification with multimethod QC: IP-RP-HPLC purity, SAX-HPLC impurity profiling, LC-MS (ESI and MALDI-TOF), ICP-MS heavy metals, GC-HS residual solvents, LAL endotoxin, bioburden, osmolality, pH, appearance |
| Sample Type | Not applicable — this is a GMP API/drug substance manufacturing service; the product is the oligonucleotide drug substance used in subsequent formulation into drug product |
| Performance Range / Specifications | Oligonucleotide 10–100 bases (modified and unmodified); scales from 1 g (preclinical) to >1 kg (commercial); purity ≥95% by validated IP-RP-HPLC; individual impurity ≤1.0% (reporting threshold 0.1%); full phosphorothioate, 2′-OMe, 2′-MOE, LNA, and other modifications supported |
| Sensitivity / LOD | Analytical methods validated per ICH Q2(R1): HPLC method LOQ ≤0.05% of main peak; LC-MS method capable of detecting and identifying impurities at ≥0.1% level; host cell protein and residual reagent assays where applicable |
| Specificity | Full-sequence identity confirmed by ESI-TOF or Orbitrap MS with mass accuracy <5 ppm; sequence verified by enzymatic digestion and LC-MS/MS mapping; any modifications (PS, 2′-OMe, LNA) confirmed by MS and ³¹P NMR as appropriate; process-related impurities (n–1, n+1, deprotected intermediates) identified and controlled to ≤1.0% each |
| Reaction Conditions / Protocol | GMP batch record controls: raw material dispensing in Class 8 cleanroom; synthesis in qualified synthesizer under controlled temperature and reagent flow; cleavage and deprotection under validated conditions; HPLC purification with fraction collection triggered by real-time UV monitoring; ultrafiltration/diafiltration for desalting and concentration; lyophilization under aseptic conditions; final packaging in ISO Class 7 environment |
| Components / Formulation | GMP-grade lyophilized oligonucleotide drug substance in validated container-closure system; GMP certificate of analysis; GMP certificate of conformance; batch manufacturing record; executed batch record; summary of in-process controls; stability protocol and commitment; retained samples archive |
| Storage Conditions | As defined in drug substance specification and stability protocol; typically –20 °C ± 5 °C with continuous temperature monitoring and alarm system; secondary containment for storage |
| Shelf Life | Shelf life assigned based on real-time stability data per ICH Q1A(R2); initial retest period typically 12–24 months with extension based on ongoing stability program; photostability per ICH Q1B evaluated |
| Package Specifications | Validated container-closure system: USP Type I borosilicate glass vials with fluoropolymer-coated stoppers; filled under ISO Class 7 aseptic conditions; fill volume verified by in-process check weighing; crimped overseal with tamper evidence; labeled per GMP and clinical trial requirements; secondary packaging for shipment |
| Product Form | Lyophilized white to off-white powder or cake; uniform appearance; reconstitution time verified if applicable |
| Quality Control | Full GMP release testing per approved specification: appearance, identity (MS and co-injection HPLC), purity and impurity profile (IP-RP-HPLC and SAX-HPLC), assay (A260 vs. qualified reference standard), molecular weight (ESI-MS), endotoxin ≤0.05 EU/mg, bioburden ≤1 CFU/10 mg (pre-sterilization), pH, water content (Karl Fischer) ≤5.0%, residual solvents per USP <467>, heavy metals per USP <232>/<233> (Class 1, 2A, 2B), counterion assay (Na⁺ by ICP-OES or IC), osmolality, particulate matter. Stability-indicating assays at each time point. Out of specification (OOS) and out of trend (OOT) procedures in place. |
| Key Features | Full GMP (ICH Q7) compliant manufacturing for clinical and commercial supply; dedicated or campaign-segregated suites; validated processes with CPP/CQA framework; Qualified Person (QP) batch release for EU clinical trials; US FDA Drug Master File (DMF) preparation support; ASMF/CEP dossier support; regulatory CMC authoring assistance; stability program per ICH Q1; vendor audit program for raw materials; quality agreement and technical agreement established; annual product quality review. |
| Purity | ≥95.0% by validated IP-RP-HPLC (main peak area %); individual related substance ≤1.0% (specified) and ≤0.5% (unspecified); total impurities ≤5.0%; n–1 impurity ≤1.5% (typically <0.5%) |
| Concentration | Assay 90.0–110.0% of label claim by validated UV A260 method against qualified reference standard; water content corrected for anhydrous, solvent-free basis; specific potency assay where applicable (e.g., aptamer binding ELISA) |
| Activity / Unit Definition | Potency assay: method dependent on product class (binding assay, cell-based functional assay, in vivo target engagement biomarker); specification range per product-specific validation; reference standard qualification per ICH Q7 section 11.1 |
| Molecular Weight | Exact monoisotopic mass determined by high-resolution ESI-MS (Orbitrap or Q-TOF) with mass accuracy <5 ppm; average molecular weight calculated from confirmed sequence; reported on CoA |
| Source / Origin | Synthetic phosphoramidite chemistry; all starting materials (phosphoramidites, CPG supports, reagents, solvents) from GMP-qualified and periodically audited suppliers; certificates of analysis for all raw materials reviewed before use; no animal-derived materials in manufacturing process; TSE/BSE statement available |
| pH Range / Optimal pH | Drug substance pH specification as per product-specific specification (typically 6.5–8.5 for reconstituted solution); pH stability data generated per ICH Q1A(R2) for forced degradation pH conditions |
| Shipping Conditions | Validated cold chain shipping: –20 °C ± 5 °C with calibrated continuous temperature data loggers; qualified insulated shipping containers with phase-change materials; shipping validation performed per Parenteral Drug Association (PDA) Technical Report 39 for cold chain; import/export permits coordinated as needed |
| Expiration Date / Stability | Retest period assigned based on real-time stability data: long-term (–20 °C, 25% RH or as specified), intermediate (2–8 °C), and accelerated (25 °C/60% RH) conditions per ICH Q1A(R2); photostability per ICH Q1B; in-use stability for reconstituted product if applicable; ongoing stability program with annual pull points to extend retest period; forced degradation study for method validation |
| Regulatory / Compliance | Manufactured under GMP per ICH Q7 Active Pharmaceutical Ingredients guideline; facility operates under national competent authority GMP certificate; EU GMP Part II (APIs) and Annex 2 (biological active substances) compliance; FDA 21 CFR Part 211 compatible; Type II Drug Master File (DMF) filing support for US FDA; ASMF (formerly EDMF) for EU submissions; CTD Module 3 (Quality / CMC) authoring support; Qualified Person (QP) audit and batch release for EU IMP; quality agreement and pharmacovigilance agreement established |
| Compatibility | Compatibility studies with intended formulation buffer, container-closure system, and administration components; forced degradation profile characterized; excipient compatibility study data available; no unexpected degradation products identified upon storage at recommended conditions |
| Recommended Buffer System | Drug substance typically lyophilized from water for injection (WFI) or ammonium acetate buffer (volatile); formulation buffer for drug product as per customer CMC development; compatibility of drug substance with formulation buffer verified |
| Application Notes / Precautions | GMP manufacturing requires establishment of a quality agreement and technical/supply agreement before campaign initiation. Process validation (PPQ) typically performed across three consecutive GMP lots before commercial supply. Analytical method validation completed before lot release testing. Stability protocol and commitment established at first GMP lot. Regulatory starting material designation should be agreed with health authorities before GMP campaign. Request a GMP capability statement and site master file for regulatory submission preparation. |
| Batch-to-Batch Consistency | Process validation demonstrating intra-batch homogeneity and inter-batch reproducibility across minimum three consecutive PPQ lots; SPC trending of critical quality attributes (purity, impurity profile, assay, water content, endotoxin); annual product quality review (APQR) evaluating all lots manufactured in review period; CPP monitoring and trending; OOS/OOT rate <1%; lot disposition by QA and QP |
For research use only, not for clinical use.
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