goldennet

Production Process Research and Development

At Genomics BioSci, we offer customized research and services for nucleic acid and peptide synthesis tailored to your specific requirements. Utilizing solid-phase synthesis, we can assess synthesis routes and produce trace amounts (microgram level) for pre-clinical development, which can then be scaled up to large-scale production (gram level) for clinical trials.

Optimization, Scale-up and Validation of Production Processes

To optimize production processes, reduce environmental impact, and minimize costs, our teams at Genomics BioSci focus on improving total production yield, enhancing scaled-up operations, and ensuring process safety and stability. We design and validate processes based on the Quality-by-Design (QbD) concept. Additionally, we adhere to PIC/S GMP regulations to create, review, approve, and securely maintain all production process records and process control analysis reports.

Development of Analytical Methods and Validation

Based on the different phases of product development, from pre-clinical to commercial production, our teams provide customers with the following services: comprehensive and customized analytical services, development of analytical methods, method verification and validation, GMP process control, raw material and product release (both semi-finished and finished), and stability testing that complies with regulatory standards. We also adhere to PIC/S GMP regulations to create, review, approve, and securely maintain all analytical reports and certificates.

Stability Test

Our teams assist customers in designing tailored stability tests, managing batch stability test schedules, and providing stability testing services that comply with regulatory requirements. We adhere to ICH storage conditions, including: -20 ± 5 °C, 5 ± 3 °C, 25 ± 2 °C / 60 ± 5 % RH, 30 ± 2 °C / 65 ± 5 % RH, and 40 ± 2 °C / 75 ± 5 % RH.

CMC Documents

Our team provides the necessary CMC (Chemistry, Manufacturing and Controls) documentation required at different phases of product development (from pre-clinical to commercial mass production).