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Transfer and Validation of Production Processes
Oligonucleotide drugs are a class of innovative therapeutics based on nucleic acid sequences, which are widely used in the fields of RNAi (siRNA), mRNA vaccines, etc. As an important part of our oligonucleotide drug CDMO services, Protheragen BioNucleics stands at the forefront of this innovation, and we can provide transfer and validation services for the production process of oligonucleotide drugs.
Transfer and Validation Services for Manufacturing Processes
Establishing and validating oligonucleotide drug manufacturing processes involves complex procedures that require adherence to various technical and regulatory standards.
- Product and Process Assessment
Our engineering team possesses comprehensive knowledge about the chemical characteristics and therapeutic roles of oligonucleotides. Achieve complete understanding of the initial production process.
- Determine the Transfer Strategy
Evaluate potential CDMO partners by assessing their technical abilities and operational experience. Create a comprehensive transfer plan which specifies time nodes alongside necessary resources and key milestones.
- Method Validation
Our validation process confirms that all analytical methods including HPLC and qPCR perform effectively in the CDMO environment. We validate analytical methods to confirm their equal effectiveness when used within a CDMO environment.
- Equipment and Technology Transfer
Our engineers handle both calibration and validation of the CDMO equipment to meet production specifications. The CDMO may need to make process optimizations and adjustments to suit its existing equipment and production scale.
- Quality Management
Our engineering team defines product quality standards and creates a matching quality control system. Production records along with laboratory records and validation reports must all remain intact while keeping track of their origins.
- Continuous Monitoring and Feedback
During production it's necessary to observe important parameters regularly to maintain consistent product quality. Set up a communication and feedback system with CDMO to address potential issues quickly.
CDMO in Oligonucleotide Drug Production
Process Development
To maintain quality standards and repeatable results for target molecules the CDMO must possess comprehensive capabilities in oligonucleotide synthesis, purification techniques, and analytical method development.
- Synthesis process development
- Purification process development
- Analytical method development
Process Scale-up
Laboratory pilot processes generally fit mg-scale production whereas commercial production demands kg-scale operations. CDMO needs to demonstrate scalable production capabilities that maintain process stability and feasibility following optimization.
- Synthesis scale-up
- Adaptation of purification system
- Buffer preparation and storage
Process Transfer
Process transfer involves moving a laboratory developed process to the GMP production facility to maintain product quality and yield across various production settings.
- Technical evaluation
- GMP production facility adaptation
- Process optimization and parameter definition
- Engineering batch production
GMP Production
CDMO needs to have cGMP-compliant production facilities that can support the production of oligonucleotide drugs of different doses and specifications.
- Strict environmental control
- Complete quality management system (QMS)
- Comply with ICH Q7 (API GMP) standards
Quality Control and Regulatory Support
CDMOs need to provide a full range of quality management services to ensure that products comply with various regulatory requirements.
- Raw material testing (oligonucleotide monomers, excipients).
- In-process testing (pH, concentration, purity during synthesis).
- Finished product testing (HPLC, LC-MS, UV, CE).
Key Criteria for Selecting a CDMO
| Evaluation Criteria | Key Points |
|---|---|
| Technical capabilities | Whether it has mature oligonucleotide synthesis, purification and analysis capabilities |
| GMP certification | Whether it complies with ICH Q7 (API GMP) requirements |
| Production scale | Whether it can support gram-level to kilogram-level production |
| Quality system | Whether it has a complete QMS (quality management system) |
| Regulatory support | Whether it can provide IND, NDA, DMF filing support |
| Delivery capabilities | Whether it can deliver on time and meet project schedule |
Protheragen BioNucleics is dedicated to providing process transfer and validation services for highly effective oligonucleotide therapeutics. Contact us to realize your full research and therapeutic.
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.
