Technology Transfer and Scale Up Pilot and Clinical Manufacturing

  • Initial Assessment: Evaluate formulation, process, and analytical methods.
  • Feasibility Study: Assess scalability and equipment compatibility.
  • Protocol Development: Create detailed transfer plan, timelines, and criteria.
  • Documentation and Training: Prepare comprehensive documentation and provide personnel training.
  • Execution of Transfer: Implement transfer process, monitor parameters, and conduct validation studies.
  • Process Optimization: Continuously improve efficiency and product quality.
  • Regulatory Compliance: Ensure adherence to regulatory requirements throughout the process.
  • Post-Transfer Support: Provide ongoing assistance and conduct reviews for continued success.
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Apurun specializes in drug delivery system-based drug formulation, providing comprehensive technology transfer services from laboratory-scale development to GMP suites or scaling up GMP operations. Our offerings include all-inclusive processes for manufacturing and scaling nanomedicines, ensuring seamless transition and consistent quality throughout the production process. Moreover, we offer a complete panel of analytical services for quality control, characterization, optimization, and stability studies of pharmaceutical injectables and nanoparticle-based pharmaceuticals. With a focus on innovation, reliability, and regulatory compliance, Apurun is your trusted partner for advancing drug delivery technologies and bringing novel therapeutics to market.

At Apurun, we specialize in providing seamless technology transfer services, facilitating the transition of drug formulations from laboratory-scale development to GMP suites or scaled-up operations. Our comprehensive approach ensures that your innovative drug delivery systems are successfully transferred and manufactured with precision and efficiency. Here are the key steps involved in our technology transfer process:

1. Initial Assessment:

  • Conduct a thorough evaluation of the formulation, process, and analytical methods.
  • Identify critical process parameters and quality attributes essential for product performance and regulatory compliance.

2. Feasibility Study:

  • Perform a feasibility study to assess the scalability of the formulation and manufacturing process.
  • Determine the compatibility of equipment and facilities for scaled-up operations.

3. Protocol Development:

  • Develop a detailed technology transfer protocol outlining the transfer plan, timelines, responsibilities, and acceptance criteria.
  • Define critical process parameters and performance indicators to ensure consistency and quality throughout the transfer process.

4. Documentation and Training:

  • Prepare comprehensive documentation including batch records, standard operating procedures (SOPs), and validation protocols.
  • Provide training to personnel involved in the technology transfer process, ensuring proficiency in new procedures and equipment.

5. Execution of Transfer:

  • Execute the technology transfer according to the established protocol, closely monitoring process parameters and product quality.
  • Conduct validation studies to verify the robustness and reproducibility of the transferred process.

6. Process Optimization:

  • Continuously optimize the transferred process to improve efficiency, reduce costs, and enhance product quality.
  • Implement feedback mechanisms to address any challenges or deviations encountered during manufacturing.

7. Regulatory Compliance:

  • Ensure compliance with regulatory requirements and guidelines throughout the technology transfer process.
  • Prepare and submit regulatory filings as necessary to obtain approvals for commercial manufacturing.

8. Post-Transfer Support:

  • Provide ongoing support and assistance following completion of the technology transfer process.
  • Conduct periodic reviews and audits to ensure continued compliance and optimization of manufacturing operations.

At Apurun, we understand the importance of a seamless and efficient technology transfer process in bringing innovative drug delivery systems to market. With our expertise and commitment to excellence, we guide our clients through every step of the transfer journey, ensuring successful outcomes and continued success in pharmaceutical manufacturing. Partner with us for your technology transfer needs and experience the difference of working with a trusted leader in drug delivery solutions.