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GMP Manufacturing
Oligonucleotide drugs are a class of therapeutic drugs based on short-chain DNA or RNA. In recent years, they have shown great potential in the treatment of genetic diseases, tumors, viral infections, etc. With the rapid development of this type of drug, Good Manufacturing Practice (GMP) manufacturing services are a key link to ensure their quality, purity, safety and traceability. Protheragen BioNucleics is a company focusing on the research and development and production of oligonucleotide drugs, providing integrated services from early development to commercialization. Its GMP manufacturing services cover the synthesis, purification, analysis, aseptic production and quality control of oligonucleotide drugs, in line with international drug regulatory standards.
GMP Manufacturing Service
GMP manufacturing services cover all stages from preclinical to commercialization, ensuring that products meet the regulatory requirements of international pharmaceutical regulatory agencies for drug quality. GMP is the core specification to ensure drug quality and safety. As a new type of therapeutic drug, oligonucleotide drugs must meet strict GMP standards before they can be used in non-clinical trials and marketed. The GMP manufacturing services related to oligonucleotide drugs that we can provide include:
- GMP-level facilities and environmental control
- Batch traceable production process
- Process validation
- Raw material quality control (QC)
- Batch record and document integrity
- Environmental monitoring (EM)
Service Scope
| Service Modules | Description |
|---|---|
| Oligonucleotide Synthesis | Supports multiple types: DNA, RNA, siRNA, ASO, aptamer, LNA, mRNA fragments, etc. |
| Modification and Ligation | Provide 5'/3' end modification (such as PEG, Cy5, FAM, GalNAc, lipid tail, etc.) |
| Purification Process | RP-HPLC, IEX-HPLC, ultrafiltration and other high purification solutions |
| Aseptic Filling | Provide aseptic filling and lyophilization services for injection-grade preparations |
| Quality Control (QC) | LC-MS, UV, HPLC, CE, electrophoresis, endotoxin and other detections |
| Quality Assurance (QA) | Batch records, deviation control, release review, compliance support |
| Stability Study | ICH-guided long-term and accelerated stability studies |
| CMC Document Support | Provide CMC information and technical support required for registration applications |
Quality Control Test Items
| Test items | Methods |
|---|---|
| Sequence Confirmation | LC-MS, MALDI-TOF |
| Purity Determination | HPLC, CE |
| UV Absorption | UV analysis |
| Residual Solvents | GC |
| Endotoxins | LAL method |
| Microbial Limits | Culture test |
| Sterility | Sterile culture test |
| pH, Conductivity | Physical and chemical index test |
GMP Production Process
Key Technical Points of GMP Production
- Solid Phase Synthesis Technology: Supports a variety of oligonucleotide types (DNA, RNA, ASO, siRNA, etc.)
- Quality Standard Establishment: Including sequence confirmation, purity, impurity spectrum, endotoxin, etc.
- Aseptic Process Design: Especially suitable for injectable oligonucleotide preparations
- Tail Modification Capabilities: PEGylation, GalNAc, lipid connection and other targeted modifications
- Batch Consistency Control: Process validation and continuous production consistency study
GMP Manufacturing Stage Support
| Stage | Service content |
|---|---|
| Preclinical/IND | Small batch GMP synthesis, support for IND application |
| Clinical Phase I/II | Batch scale-up, stability support |
| Clinical Phase | Commercial process validation, consistency of three batches |
Challenges in Oligonucleotide Drug Production
- Complex chemical synthesis: including multi-step reactions such as phosphorylation and protecting group treatment.
- Difficult purification: impurities such as residual reagents and truncated chains need to be removed efficiently.
- Strong sequence specificity: the sequence of each drug is different, and it is almost customized production.
- High quality requirements: high purity, sterility, endotoxin and other standards need to be met.
Protheragen BioNucleics is dedicated to oligonucleotide pharmaceutical GMP manufacturing services. If you would like to learn more, please Contact us today.
Our services and products are exclusively for authorized organizations in research, development, or manufacturing and are not intended for direct use by individuals or patients or as medical advice, diagnosis, or treatment.
