Process Validation & Qualification Services

Process Validation & Qualification Services

Ensuring Consistent, High-Quality Drug Production at Every Stage of Development

At Aragen, we specialize in providing comprehensive Process Validation & Qualification Services throughout the lifecycle of small molecule drug substance development. From early-stage process development through to commercial-scale manufacturing, we ensure that every batch is produced consistently and in compliance with industry regulations, including GMP (Good Manufacturing Practice).

Our Process Validation & Qualification Services

Early Phase

In the early phases of development, the primary goal is to establish a reliable and scalable manufacturing process for your drug substance. At this stage, we help develop and optimize your process while ensuring that your product is consistent enough for preclinical and early clinical trials.

• Process Design & Development: Tailored process development based on your molecule’s characteristics, focusing on optimizing scalability and robustness.
• Pilot-Scale Production: Production at pilot scale to assess process reproducibility and to produce sufficient material for preclinical and Phase I clinical trials.
• Initial Process Validation: Feasibility studies to test small-scale processes and ensure product quality and stability for early-stage trials.
• Risk Management: Identification and mitigation of potential process risks, including material variability, equipment performance, and critical process parameters.

During the late phase of development, the process must be validated to meet regulatory standards for large-scale manufacturing. At this stage, we focus on ensuring that the process can be reliably scaled up, meeting stringent regulatory requirements for clinical trials and eventual commercialization.

• Process Optimization: Refinement of the manufacturing process to ensure it is scalable, reproducible, and robust enough to meet clinical demands.
• Formal Process Validation (PPQ): Validation of the commercial manufacturing process through Process Performance Qualification (PPQ), typically involving multiple consecutive production batches to establish consistency.
• Critical Quality Attributes (CQA) Analysis: Thorough analysis and control of the critical quality attributes (CQAs) that directly affect product safety, efficacy, and quality.
• Documentation & Regulatory Compliance: Preparation of comprehensive documentation for submission to regulatory agencies, ensuring compliance with regulatory guidelines (e.g., FDA, EMA).

In the commercial phase, your manufacturing process must be fully validated and compliant with GMP standards. We support you in the ongoing monitoring and continuous improvement of your process to ensure consistent production of high-quality drug substance over the long term.

• Full-Scale Manufacturing & GMP Compliance: Support for large-scale commercial manufacturing under GMP conditions, ensuring that each batch meets the required quality specifications.
• Process Performance Monitoring & Control: Ongoing monitoring of critical process parameters and quality attributes to ensure continued process control and product consistency.
• Process Validation Maintenance: Continuous evaluation and re-validation of the process in response to changes in raw materials, equipment, or production conditions.
• Regulatory Filing Support: Assistance with regulatory filings and ensuring that all process validation data is available for inspection and approval by regulatory bodies.

Our Approach 

Our process validation & qualification services follow a structured, scientific approach:

• Process Understanding & Development: We thoroughly analyse the drug substance manufacturing process, identifying critical process parameters (CPPs) and quality attributes (CQAs).
• Risk Assessment: A comprehensive risk assessment is conducted to identify potential process variations and risks, and to define appropriate controls to mitigate these risks.
• Design of Experiments (DOE): Using DOE methodologies, we systematically optimize process parameters to ensure robustness and reproducibility.
• Validation Protocols & Execution: We develop detailed validation protocols and execute them to confirm that the process consistently meets predefined quality standards.
• Documentation & Regulatory Support: The necessary documentations are prepared by our experts for regulatory submissions, ensuring compliance with FDA, EMA, and other international regulatory bodies.
• Ongoing Support: Our services extend beyond validation to include continuous process monitoring, process improvements, and re-validation when necessary.

Why Choose Us?

Expertise Across All Phases: Our team of scientists and engineers has deep expertise in small molecule process validation and qualification at every stage of development.

Proven Track Record: We have successfully completed 57 PRD projects and 100+ clinical and commercial programs and 18 long term supply programs with global clients in bringing small molecule drugs to market, ensuring process consistency and compliance with regulatory requirements.

Tailored Solutions: We understand that every drug substance is unique. Our services are customized to meet the specific needs and challenges of your project.

Regulatory Expertise: We stay updated with the latest regulatory requirements to ensure that your process validation activities meet the expectations of regulatory agencies like the FDA, EMA, and ICH.

Cutting-Edge Technologies: We utilize the latest technologies and methodologies to optimize processes and ensure robust, scalable, and cost-effective drug manufacturing.