Particle Science and Engineering Services

Particle Science and Engineering Services 

Optimizing Drug Substance Performance through Advanced Particle Science & Engineering techniques 

At Aragen, we understand the physical properties of drug substances are integral to the development of high-quality drug products. Variations in these properties can significantly impact a drug product’s performance, stability, and manufacturability. To address these challenges, we offer comprehensive Particle Science and Engineering services tailored to meet your specific drug substance development needs—from early-stage research to final product optimization.

Our expertise in particle engineering ensures that the physical properties of your drug substance, such as particle size distribution (PSD), bulk density, surface area, flowability, and polymorphism etc., are precisely controlled to optimize drug product development.

Our highly motivated and dedicated team can design the process using scientific and data driven and PAT based approach. Our team uses DOE approach in all crystallization development to identify the optimum design space to obtain desired drug substance physical attributes.

Once the process is developed our experts carry out the robustness study using Qbd methodology (FMEA, Risk Assessment etc.) to identify the potential risk w.r.t scale up and provide appropriate control strategy to ensures the successful scale up.

Our Particle Science & Engineering Services

At Aragen, our comprehensive particle science and engineering services are designed to meet the unique needs of your drug substance. Our experienced team works with you to develop scalable solutions, ensuring that all critical material attributes are optimized throughout the lifecycle of your drug substance and drug product.

Comprehensive Solid Form Development for Drug Substances

Solid form development is essential for optimizing the stability, bioavailability, and performance of drug substances. We offer extensive solid form development services to optimize the stability and performance of your drug substance:

• Polymorph Screening: Identifying and selecting the most stable and bioavailable polymorphs to enhance drug bioavailability and performance.
• Co-Crystal Screening: Identifying potential co-crystals that improve solubility and stability, contributing to better drug formulation.
• Polymorph Stability Studies: Evaluating the stability of polymorphs under various conditions to ensure long-term shelf-life and efficacy.
• Polymorph Process Development: Developing robust crystallization processes to consistently produce the desired polymorph with high purity and yield.

Particle Size Control & Optimization for Drug Substances

Particle size plays a critical role in drug bioavailability and manufacturability. Our advanced particle engineering technologies are designed to precisely control the size, shape, and distribution of your drug substance particles, by developing proper crystallization process ensuring high recovery, consistent quality and manufacturing efficiency. Our solutions facilitate:

• Improved Bioavailability: By optimizing particle size, we enhance the drug’s absorption and bioavailability, leading to more effective treatments.
• Manufacturing Efficiency: Our controlled particle size improves the efficiency of the manufacturing process, reducing batch failures and enhancing consistency.
• Scalability: With optimized particle properties, we make it easier to transition from small-scale research to large-scale commercial production, saving time and reducing costs.

Powder Processing for Particle Engineering

Powder processing is essential for optimizing drug properties like flowability and bioavailability through precise particle size control. It ensures consistent product quality, with flexible batch or continuous processing to meet specific size requirements. This efficiency accelerates development and speeds up time to market.

Our facility is well-equipped with powder processing equipment, to achieve the desired particle characteristics. These include:

Air-Jet Mill (M-50):

• Size Reduction: Bench-scale trials for optimal particle size distribution (PSD), reducing the number of trials needed for commercial-scale production.
• Lab Dispatch: Ensuring that lab dispatch products meet the required PSD for consistency and quality.
• Capacity & Pressure: Conducting trials with feed rates up to 100 g/h and grinding pressures up to 6 Kg/sqcm for precise size reduction.

Wet Mill:

• Temperature-Sensitive Products: Ideal for size reduction of heat-sensitive compounds in drug development.
• Versatile Modules: Fine, medium, and coarse modules to accommodate different drug substance requirements.
• High-Speed Processing: Speeds up to 25,000 RPM with a processing capacity of 130 l/h for both batch and continuous processing.

Advanced Process Analytical Technology (PAT) Tools

We utilize advanced Process Analytical Technology (PAT) tools, such as Blaze Metrics, to provide real-time monitoring and control over critical processing parameters during drug substance development. These tools enable in-depth tracking of key aspects like crystallization processes, crystal size distribution, and polymorphic transitions, ensuring the development of high-quality drug substances.

Our solutions include:

• Real-Time Process Control: Continuous monitoring allows for immediate adjustments to processing parameters, reducing batch failures, and maintaining consistent product quality.
• Faster Development Cycles: Real-time data on crystal growth and polymorph stability helps minimize the need for extensive post-processing testing, accelerating the development process.
• Improved Drug Quality: Precise control over critical factors ensures that your drug substance retains its optimal properties, enhancing solubility, stability, and overall effectiveness.

Our PAT tools streamline and optimize the development process, driving faster, more efficient, and higher-quality drug development outcomes.

Why Aragen ?

At Aragen, our expertise in particle science and engineering ensures that your drug substance is optimized for performance, stability, and manufacturability. Our comprehensive services are designed to address the specific challenges of your drug development process, ensuring that your final drug product meets the highest quality standards. We offer:

• Customized Solutions: Tailor-made particle engineering services to optimize particle size, improve solubility, and ensure polymorph stability.
• Comprehensive Expertise: Continuous support from early-stage research to commercial manufacturing, optimizing critical material attributes at every stage.
• Advanced Technologies: Access to state-of-the-art equipment and process analytical technology for ideal drug substance properties.
• Regulatory Compliance: Fully aligned with global regulatory standards, ensuring your drug substance development meets industry requirements.