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Daily: 9.30 AM–6.00 PM
Sunday : 9.30 AM–1.00 PM
Holidays: Closed
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Filling Capacity
The unique physical and chemical properties of oligonucleotide drugs make them key drivers in the advancement of gene therapy and precision medicine. Aseptic filling serves as a fundamental connection to maintain quality standards, safety protocols and consistent results throughout non-clinical research as well as commercialization stages. Protheragen BioNucleics focuses on providing high-quality, full-process oligonucleotide drug formulation development services, covering a variety of administration routes and dosage forms to meet different non-clinical needs.
Oligonucleotide Drug Filling Service
Our one-stop oligonucleotide drug filling services span research and development through non-clinical application stages to address various filling requirements for multiple dosage forms and specifications across different batches while supporting fast and steady drug development progress.
| Service Modules | Description |
|---|---|
| Filling Form | Sterile liquid filling (vials, prefilled needles) |
| Drug Type | ASO, siRNA, miRNA, aptamer, CpG and other oligonucleotide drugs |
| Sterility Assurance | Sterile isolation system, Class 100 filling environment, to ensure the sterility of the entire filling process |
| Inspection and Release | Microbial limit, sterility test, filling volume uniformity, pH, osmotic pressure and other tests |
| Packaging Form | Vials, ampoules, prefilled needles, lyophilized filling (optional) |
GMP Level Support
- Can undertake GMP filling services for non-clinical trial drugs
- Provide complete filling batch records, verification materials, COA reports
Advantages of Oligonucleotide Drug Filling Service
- Low Adsorption Filling System: Specially designed for oligonucleotides to reduce drug adsorption loss
- Cold Chain Support: 2~8°C or -20°C cold chain operation and storage throughout the process
- Supporting Analysis Services: HPLC, UV, qPCR and other pre- and post-filling quality testing
- Registration Application Support: Filling process information and quality documents required for CTD module
Scope Application
- Preparation of samples for early drug development
- Production of samples for non-clinical phase I-III
- IND/NDA registration filling batches
- Preparation of samples for stability studies
- Preparation of filling samples for GLP toxicology studies
Considerations
The filling process of oligonucleotide drugs requires careful consideration of the following aspects:
- Aseptic Operation: The production of oligonucleotide drugs requires a sterile environment for filling to prevent contamination.
- Stability: Oligonucleotide stability depends on the surrounding temperature, pH levels and ionic strength conditions. It is essential to maintain the filling process conditions within a specific range to preserve the stability of the drug.
- Dose Accuracy: The filling process requires strict control over drug dosage consistency in every container.
- Equipment Selection: Aseptic filling machines and automated filling systems as appropriate filling equipment lead to improved efficiency and accuracy.
- Quality Control: Each batch of drugs must undergo quality testing after filling to verify compliance with drug standards.
Protheragen BioNucleics is a professional organization focusing on nucleic acid drug development and formulation services, ranging from early research to the development and production of drugs for non-clinical trials. Contact us to fully realize your research and treatment potential.
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.
