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

Application Requirements

In vaccine research and development, the R&D department, CRO, quality control laboratory and regulatory agency of pharmaceutical companies are the core units. Pharmaceutical companies and CROs focus on target screening and vector evaluation, quality control laboratories are responsible for production monitoring and final product verification, and regulatory agencies review compliance. The purpose is to ensure the effective expression of vaccine targets, no exogenous contamination in production, and the purity of the final product. Requires high technical sensitivity (trace contamination/residue detection), rapid quantitation (adaptation to production efficiency), multiplexing analysis, and compliance. The current traditional culture method takes a long time, some PCR has multiple interferences, the cost of new technology is high, the standardization is insufficient, and the complexity of grassroots operation is high. 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

Vaccine R&D Departments, University / Institute Vaccine Labs, CROs

Quantitatively detect the expression levels of candidate vaccine target genes (e.g., viral S protein gene, bacterial antigen gene), verify vaccine-induced gene regulation effects, and evaluate immunogenicity mechanisms.

Gene Therapy R&D Centers, Viral Vector Laboratories

In the development of viral vector vaccines (e.g., adenovirus vector, AAV vector), qPCR is used to quantify vector genome copy number and evaluate vector transduction efficiency and stability.

Production Workshop QC Teams, Raw Material Testing Labs

qPCR is adopted to detect exogenous contaminants such as mycoplasma, bacteria and viruses in raw materials including vaccine production cells and culture media, with sensitivity below 10 CFU/mL, meeting the requirements of the Chinese Pharmacopoeia.

Production Process QC Departments

Real-time quantitative monitoring of key indicators such as viral titer and antigen gene expression during vaccine production to ensure process stability. For example, qPCR is used to track viral proliferation curves in inactivated vaccine production.

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 vaccine R&D enterprises.

High-Efficiency Detection

Covers the entire gene detection workflow in vaccine 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 mycoplasma detection kits, offering higher cost performance to help enterprises reduce costs and improve efficiency.

Successful Cases

Needs: A pharmaceutical enterprise in Shandong used imported equipment and supporting reagents to identify mycoplasma contamination during vaccine production. The cost was high and detection sensitivity could not fully meet requirements. The client urgently needed a molecular detection solution with higher cost performance, higher sensitivity and simple operation.

Solution:

Recommended by local distributors, the pharmaceutical company systematically tested our Archimed Series qPCR instruments and mycoplasma detection kits. Our detection kits cover more than 150 species of Mycoplasma, Spiroplasma and Acholeplasma, with built-in IC to effectively monitor extraction and amplification processes and prevent false negatives.

Result Display:

Archimed combined with supporting mycoplasma detection reagents and efficient extraction systems ensures detection sensitivity up to 10 CFU/mL.

On-site Application Photo

Test Result