Drug development and development - RocGene (Beijing) Technology Co., Ltd.

Application Requirements

In drug development, pharmaceutical companies, CROs/CMOs, and quality control laboratories are the core application units. Pharmaceutical companies focus on R&D and production quality control, CRO/CMO provides testing services, and laboratories are responsible for compliance verification. Purpose Monitoring R&D, production process, verification of purity and potency of the final product. Technology with high sensitivity (trace pathogen/residue detection), multiplexing capabilities, rapid detection (adaptation for productivity), and compliance. The current traditional culture method takes a long time, and some PCR technologies have multiple interference and complex grassroots operations, and the cost of new technologies is high and the standardization is insufficient to be solved. 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

Pharmaceutical R&D Laboratories, CROs

Quantitatively detect the regulatory effects of drug candidates on specific genes (e.g., cancer driver genes) via qPCR to evaluate drug mechanisms of action.

R&D Departments, Translational Medicine Centers

Quantitatively detect gene expression changes of potential drug targets screened by high-throughput assays via qPCR and confirm interactions among multiple genes.

Regulatory Authorities (e.g., NMPA)

Verify compliance of relevant samples via qPCR and ensure authenticity and reliability of gene amplification data during drug R&D.

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 pharmaceutical R&D enterprises.

High-Efficiency Detection

Covers the entire gene detection workflow in drug R&D. Both standard and high-throughput systems can process more targets and samples simultaneously, with ultra-fast response, improving detection efficiency by over 20% compared with conventional instruments.

High Cost Performance

Combined with self-developed reagents including host cell residual detection kits and mycoplasma detection kits, we offer comprehensive services with higher cost performance, helping enterprises reduce costs and improve efficiency.

Successful Cases

Needs: A pharmaceutical enterprise in Beijing required data security, audit trail and electronic signature for R&D. Electronic data security and audit trail software had long been monopolized by imported brands, forcing the customer to purchase expensive imported equipment and supporting software. The client urgently needed a molecular detection platform with higher cost performance, simple operation and fast response.

Solution:

Recommended by our sales team, the pharmaceutical company systematically tested our Archimed Series qPCR instruments. We provided a more cost-effective solution with the ArchiSign audit trail system plus 3Q qualification service.

Result Display:

ArchiSign significantly improved the efficiency of supervision, execution and review, and reduced the cost of data audit and traceability. Compared with imported solutions, Archimed helped the enterprise cut related costs by 30%.

On-site Application Photo

Service Result