In the rapidly evolving pharmaceutical landscape, CD Formulation is dedicated to delivering comprehensive and innovative pilot-scale production services for nucleic acid drugs. We recognize the pivotal nature of every phase from laboratory research to full-scale production. Hence, our offerings are designed to ensure efficient translation of processes and exceptional product quality.

Pilot-scale Production for Nucleic Acid Drugs

Pilot-scale production is a critical transitional phase from small-scale trials to full-scale manufacturing. It allows verification of laboratory-developed processes in real production settings, ensuring each step aligns with expected quality standards. This phase is crucial not only for technical validation and optimization but also for mitigating risks in large-scale production, thereby preventing unnecessary resource expenditure and process discrepancies. Through pilot-scale production, companies can precisely analyze details of each step, providing scientific evidence and data support for future process optimizations.

Conditions for Pilot-Scale Production

• Stable yields and reliable product quality are essential during small-scale trials, ensuring that each reaction's process and parameters (such as feeding methods, reaction time, temperature, pressure, endpoint control, extraction, separation, crystallization, filtration, and drying) are defined.
• Methods and requirements for the refinement, crystallization, separation, and drying of the final product should be established, with 3-5 batches of stability testing confirming the process's feasibility and constancy.
• Quality control methods/standards for raw materials and products must be established.

Explore Our Pilot-Scale Production Services for Nucleic Acid Drugs

Methods of Pilot-Scale Production

• Incremental Scale-Up

This involves gradually expanding production units from small-scale foundations, allowing for detailed adjustments and optimization at each scale stage.

• Simulation Process Optimization

Using advanced tools, we test different scaling conditions and parameter settings in a virtual environment. Simulations effectively reduce experimental costs and help identify the best reaction time, temperature, and pressure.

Our Workflow of Pilot-Scale Production Services for Nucleic Acid Drugs

Fig.1 Flow chart of pilot-scale production for nucleic acid drugs. (CD Formulation)

• Initial Evaluation

We conduct detailed requirement analyses and direction assessments, devising a comprehensive pilot-scale plan to ensure each step aligns tightly with objectives.

• Small-Scale Data Verification

Key data from the laboratory phase is thoroughly verified and organized to ensure accurate transfer to pilot-scale, with necessary adjustments made as needed.

• Process Parameter Setting

Precise production equipment is selected, and detailed process parameters are set based on validated lab results to ensure stability and consistency during production.

• Pilot Execution

The pilot process is launched according to the plan, with advanced monitoring technology used to track each reaction stage in real-time, adjusting abnormalities to reduce risk.

• Result Analysis

Post-pilot, comprehensive data analysis and evaluation are conducted with detailed reporting to provide precise recommendations for large-scale production.

Our Technology Platforms

Equipped with HPLC and mass spectrometry systems, we can accurately analyze compound compositions, quickly detecting purity, impurities, and chemical structures.

Our Advantages of Pilot-Scale Production Services for Nucleic Acid Drugs

• Our process development team has deeply engaged in nucleic acid synthesis, adeptly handling projects ranging from tiny milligram scales to kilogram expansions.
• We gather top-tier nucleic acid chemistry experts from global leading institutions, possessing robust theoretical foundations and rich practical experience, displaying profound insights and innovative abilities in key process controls and impurity tracing.
• We strictly adhere to guiding principles, ensuring all processes from development to reporting are compliance-driven, providing steadfast legal and regulatory support for clients' innovative nucleic acid drugs to gain international approvals.
• Our company is committed to forefront technological exploration, consistently updating processes and methods to maintain industry leadership while providing clients with efficient and tailored solutions to secure project success.

Publication Data

At CD Formulation, we leverage our extensive experience and expert knowledge to offer comprehensive support in nucleic acid drug development, ensuring project excellence. Our team is always ready to assist you in overcoming various research challenges, paving the way for your innovative drugs to hit the market. Contact us to learn how we can craft bespoke solutions for your projects.