Biopharmaceutical production and quality control - RocGene (Beijing) Technology Co., Ltd.

Application Requirements

In biopharmaceutical production and quality control, raw material testing laboratory, production quality control group, finished quality control laboratory and regulatory agencies are the core units. The raw material laboratory screens for contamination, produces quality control and monitors intermediate products, and produces quality control and verifies the final product, and the regulatory agency reviews and compliance. The purpose is to ensure that the raw materials are free of foreign pollution, the production process is stable, and the purity of the final product is up to standard. Requires high technical sensitivity (trace residue/contamination detection), rapid quantitation, multiplex analysis, and compliance. The current traditional culture method takes a long time, PCR has complex sample interference, high cost of new technology, insufficient standardization, and high complexity of grassroots operation. Applications urgently need molecular detection platforms that comply with relevant regulations, have accurate results, are fast, easy to operate, and have high sensitivity.

Solutions

Biopharmaceutical Solution - ArchiPure + Archimed X Series + Audit Trail Software + 3Q Service

Sample Processing: 16/32/96 Pro throughput automatic nucleic acid extractor for high-purity nucleic acid extraction from samples (e.g., cultures), improving the sensitivity and reliability of subsequent detection.
System Construction: Manual preparation of detection system or use of Rocgene finished biopharmaceutical kits.
Detection Results: 96/384-well Archimed X Series real-time fluorescent quantitative PCR instrument combined with multiplex PCR technology, supporting amplification and melting curve analysis, meeting daily detection needs for standard-throughput experiments.
Analysis Software: Audit trail software compliant with the Draft Requirements for Drug Records and Data Management and FDA 21 CFR Part 11 data integrity requirements.

Application Scenarios

Raw Material Testing Labs, Production Workshop QC Teams

Quantitatively detect host cell residual nucleic acid in accordance with national regulations to verify the quality of incoming materials and final products.

Pharmaceutical R&D QA/QC Departments

Establish standards for production and product release during drug development in compliance with relevant regulations.

Third-Party Testing Institutions

Provide testing services for pharmaceutical enterprises and issue official test reports.

Detection Process

Biopharmaceutical Solution - ArchiPure + Archimed X Series + Audit Trail Software + 3Q Service

Our Advantages

Full Compliance

Solutions are equipped with Rocgene's self-developed ArchiSign audit trail system, providing comprehensive and reliable solutions for biopharmaceutical enterprises.

High-Efficiency Detection

Covers the entire gene detection workflow in biopharmaceutical production. Both standard and high-throughput systems can process more targets and samples simultaneously with precise quantification, efficiently ensuring result accuracy.

High Cost Performance

Combined with self-developed host cell residual detection kits, offering higher cost performance to help enterprises reduce costs and improve efficiency.

Successful Cases

Needs: The production QC department of a pharmaceutical enterprise in Jiangsu Province used an imported platform and supporting reagents for product release testing. The cost was high, and instrument failures could not be resolved in a timely manner, forcing the enterprise to outsource testing to third-party service companies, which greatly increased financial and time costs. The client urgently needed a molecular detection solution with higher cost performance, higher sensitivity and simple operation.

Solution:

Our engineers provided multiple on-site debugging and support to help the department establish an automated extraction and detection nucleic acid testing system. While reducing personnel requirements, the reagent system adopts dUTP+UNG enzyme design to effectively prevent aerosol contamination and further ensure result reliability.

Result Display:

Archimed combined with the supporting CHO residual detection kit helped the enterprise reduce related costs by 50%.

On-site Application Photo

Test Result