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Oligonucleotide Drugs CDMO
As an emerging precision treatment method, oligonucleotide drugs have shown great potential in the fields of rare diseases, genetic diseases, cancer, etc. Professional CDMO services can empower pharmaceutical companies in the entire process from research and development to commercialization. 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 and R&D needs.
Oligonucleotide Drug CDMO Services
Development and Validation of Analytical Methods
- Provide full-process services from method establishment to validation
- Including analysis of purity, content, residual solvents, secondary structure, degradation products, etc.
- Follow ICH Q2 guidelines to ensure compliance with GMP standards
Transfer and Validation of Production Processes
- Acceptance and evaluation of original process technology
- Process scale-up, optimization and technology transfer
- Cleaning validation, continuous process validation, process consistency assessment
- Provide GMP-grade API production from grams to kilograms
- Support key steps such as solid phase synthesis, deprotection, purification, and freeze-drying
- Meet the needs of different stages
Oligonucleotide Drug Preparation Development
- Involving injection, lyophilized preparations and other dosage forms
- Integrated services for prescription screening, stability assessment, and process development
- Supporting sterile preparation development and filling
Stability Testing of Oligonucleotide Drugs
- Carry out long-term, accelerated, and conditional stability studies in accordance with ICH guidelines
- Support the data required for IND, NDA, etc.
- Including stress condition testing such as temperature, humidity, and light
- Provide aseptic filling services (small volume injection)
- Support various packaging forms such as vials, prefilled needles, ampoules, etc.
- Meet the different needs of samples and commercial batches
Customized Packaging and Labeling Service
- Customized packaging size, label content and language version
- Meet regulatory requirements of different countries
- Provide packaging material design and supply chain management support for non-clinical trial drugs
Applicable Oligonucleotide Types
- Antisense oligonucleotide (ASO)
- Small interfering RNA (siRNA)
- Micro RNA (miRNA)
- Aptamer (aptamer)
- CpG oligonucleotide
- Gapmer, Mixmer and other complex oligonucleotides
Oligonucleotide Drug CDMO Service Advantages
- One-stop Service Platform: The service delivers comprehensive development from synthesizing raw materials to completing formulation filling which addresses the full product lifecycle.
- Professional Technical Team: Our technical team brings extensive experience from the oligonucleotide field while maintaining comprehensive knowledge of international regulations.
- Flexible Production Capacity: Enable fast transitions between different specifications and types of products
- Strict Quality System: meet the GMP requirements of various regulations
- Global Registration Support: Our global registration support includes IND and NDA as well as other regulatory document preparations.
- Customer Customized Service: tailor-made solutions according to different project needs
Oligonucleotide drugs are a type of DNA or RNA chain with a specific sequence, which are commonly used in gene therapy, antiviral therapy, cancer therapy and other fields. Protheragen BioNucleics provides contract development and manufacturing organization services for oligonucleotide drugs and plays an important role in the biopharmaceutical field. If you want to know more, please contact us.
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.
