Exploring AI in Oligonucleotide Manufacturing: Veliter’s Keynote at CPHI & PMEC Pharma Expo (Shenzhen)
From September 9 to 11, 2024, the second CPHI & PMEC Pharmaceutical Industry Expo (Shenzhen) officially kicked off at the Shenzhen Convention and Exhibition Center (Futian).
The exhibition, leveraging key resources from its parent event, focuses on the development of the pharmaceutical industry in the Greater Bay Area and extends its reach to the Asian market. By targeting areas such as new drug research and development and process technology innovation, the event creates a professional and efficient platform for industrial exchange and collaboration, addressing the development needs of the pharmaceutical industry in Asia.
Event: CPHI & PMEC Pharma Expo (Shenzhen)
Date: Sept 10th, 2024
Location: Shenzhen
Speaker: Alex Xu, CEO & Founder at Veliter
Veliter’s Topic: Exploring AI in Oligonucleotide Manufacturing
Artificial intelligence (AI) offers many possibilities for drug production, including but not limited to optimizing process design and control, intelligent monitoring and maintenance, and trend analysis to drive continuous improvement. AI can be deployed alongside other advanced manufacturing technologies to achieve desired benefits, bringing manufacturers a well-controlled, highly connected, and digitized ecosystem and pharmaceutical value chain.
Draft Guidance from the FDA’s Center for Drug Evaluation and Research (CDER) on “Artificial Intelligence in Drug Manufacturing”:
Artificial Intelligence: Software and hardware systems capable of perceiving the environment, interpreting data, and making decisions on actions.
AI applications in drug manufacturing primarily include process design optimization and scale-up, advanced process control, quality control and assurance, process monitoring, defect inspection, and trend analysis and detection.
Applications in Drug Manufacturing:
- Process Optimization: Modeling of process parameters, optimization of process models
- Dosage Form Development: Predicting solubility and bioavailability, designing targeted delivery systems, formulation optimization
- Automation and Control in Manufacturing: Machine learning and predictive modeling, computer vision and image analysis, process control, and optimization
- Enhanced Quality Control and Assurance: Real-time quality monitoring, predictive maintenance, defect detection, data analysis and traceability, regulatory compliance
Guangdong Veliter Biomedical Technology Co., Ltd, founded in July 2019, led by experts with specialized knowledge unique to oligonucleotide process development and manufacturing, tens of years of experience in pre-clinical and clinical development of innovative oligo drug products, come from globally recognized pharmaceutical enterprises and CDMO firms, specializes in phase appropriate analytical method development/validation, process development/validation, scale-up, non-GMP and GMP manufacturing, formulation, and CMC/regulatory solutions/services.
Our product portfolio encompasses Deoxyribonucleic acid (DNA), Ribonucleic acid (RNA), Phosphorodiamidate morpholino oligonucleotides (PMO), and Peptide-conjugated phosphorodiamidate morpholino oligonucleotides (PPMO) which diversify into ASO, siRNA, miRNA, Aptamer, circleRNA, CpG ODN, sgRNA, among others.
Reference: https://www.cphi-china.cn/shenzhen/
