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Oligonucleotide Drug Preparation Development

As the potential of oligonucleotide drugs in treating various diseases (such as cancer, genetic diseases, etc.) becomes increasingly apparent, the demand for related development services is also growing. 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 R&D needs.

Development Services for Oligonucleotide Drug Preparations

The development of oligonucleotide preparations is an important direction in the field of modern biomedicine, especially in gene therapy, RNA interference (RNAi), antisense nucleic acid (ASO), siRNA, miRNA, etc. With our advanced technology platform, experienced team and strict quality system, we are committed to providing customers with efficient and reliable solutions to help nucleic acid drugs enter the clinic and market. The development services for oligonucleotide drug preparations we can provide include but are not limited to:

Sterile Liquids

  • Support the development of drugs with multiple dosage forms
  • Strict aseptic process control
  • Support CMC document preparation and registration application

Sterile Powder Lyophilized Vials

  • Provide lyophilization process development and optimization
  • Complete lyophilization curve design and verification
  • Support commercial-scale production transformation

Dosage Forms Under Development

  • Including common injectable dosage form reagents
  • Provide stability testing
  • Provide formulation design and optimization

Formulation Development Synthesis Process 

Oligonucleotide drugs have the advantages of high specificity, strong targeting, and short development cycle, and are widely used in tumors, genetic diseases, viral infections and other fields. We are committed to helping customers efficiently advance the research and development of oligonucleotide drugs. The synthesis process includes:

1. Demand communication

2. Solution design and evaluation

3. Project launch and execution

4. Phase reporting and optimization

5. Delivery results and technical support

Chemical Modification Support and Synthesis

  • Common modifications: 2'-O-Methyl, 2'-F, PS backbone, LNA, GalNAc coupling, etc.
  • Small-scale synthesis (for screening)
  • GMP-grade large-scale synthesis support

Formulation Process Development and Optimization

  • Stability studies (temperature, pH, enzyme degradation)
  • Sustained release/targeted delivery system development
  • Process scale-up and technology transfer support

Analytical Method Development and Validation

  • Purity, concentration, sequence integrity analysis
  • Quantitative/qualitative methods such as HPLC, LC-MS, UV, etc.
  • Degradation product and impurity analysis

Why Choose Us

  • Experienced: Many years of experience in oligonucleotide drug development and formulation
  • One-stop Service: Full-process support from prescription screening to non-clinical sample preparation
  • Quality-oriented: Comply with international quality standards
  • Quick Response: Efficient project management mechanism to ensure project progress

Our Formulation Development Services for Oligonucleotide Service Advantages

  • Professional oligonucleotide pharmaceutical R&D team
  • Complete analytical method development and validation system
  • GMP-grade preparation process and production platform
  • Support IND/NDA application material writing and technical support
  • Advanced equipment and automation system to improve R&D efficiency

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.

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