Our promise to you:
Guaranteed product quality, expert customer support.
24x7 CUSTOMER SERVICE
CONTACT US TO ORDER
Oncolytic viruses (OVs) are a class of naturally occurring or genetically engineered viruses that selectively replicate within tumor cells and induce tumor cell lysis, while simultaneously stimulating anti-tumor immune responses in the host. With strong tumor specificity, excellent safety profiles, minimal side effects, and relatively low production costs, OVs have emerged as a promising modality in cancer immunotherapy. Leveraging its robust viral engineering platforms and biopharmaceutical capabilities, Creative Biogene offers end-to-end services covering both CRO and CDMO segments, from early discovery to IND filing and clinical manufacturing, to help global partners accelerate oncolytic virus drug development and commercialization.
Creative Biogene possesses extensive experience in oncolytic virus development and has established standardized systems for viral construction and functional validation tailored to various virus types. We provide integrated one-stop R&D services—from viral design, construction, and validation to in vitro and in vivo functional assessment—streamlining preclinical research and facilitating IND-enabling studies.
Creative Biogene provides full-process CDMO services—from process development and pilot-scale production to GMP-grade manufacturing and quality control—supporting scalable production of both DNA and RNA oncolytic viruses for preclinical, clinical, and commercial needs. As a well-established CDMO provider, Creative Biogene brings together comprehensive expertise in oncolytic virus production, multiple virus technology platforms, and a mature quality control system.
Vector and Master Cell Bank Construction
Design and construct high-potency oncolytic virus vectors along with sterile, scalable seed stock systems, compatible with adherent or suspension-based triple-tier seed banks.
Process and Method Development
Develop upstream, purification, formulation, and analytical methods to ensure scalability, consistency, and regulatory compliance.
Upstream Production (Virus Amplification)
Select optimal packaging systems and culture strategies (adherent or suspension) based on virus type, and perform scalable production in bioreactors ranging from 50–200L or larger.
Downstream Purification
Use fully closed, automated systems for virus purification, with proprietary safety technologies to maintain bioactivity and ensure operator safety.
Product Delivery
Deliver final product vials, seed banks, Certificates of Analysis (COAs), batch production records, test reports, and supporting CMC documentation.
Quality Control & Batch Release
Implement a robust quality management system compliant with global regulations, including batch testing, release, and stability studies.
Aseptic Filling & Formulation
Conduct formulation and sterile filling in automated Grade A isolator systems to ensure final product quality and injection readiness.
From process development to GMP manufacturing and regulatory documentation, our integrated timeline ensures every milestone is met efficiently—because in oncology, time matters.
We implement a full spectrum of testing and release strategies based on ICH, FDA, and NMPA standards, including:
| Category | Example Tests | Methods |
| Identification | Protein ID, serotype confirmation, morphology | Western blot, EM, neutralization |
| Quantification | Genome titer, infectious titer, specific activity | qPCR, plaque assay |
| Bioactivity | Tumor lysis, protein function | CCK8, functional assays |
| Impurities | HCP, residual DNA, nucleases | ELISA, capillary electrophoresis |
| Safety | Sterility, mycoplasma | Culture method, qPCR |
Creative Biogene has successful experience in clinical IND submissions and strictly adhere to GMP compliance. Our dedicated project management team ensures efficient communication, transparency, and reliable on-time delivery.
As oncolytic virotherapy becomes a cornerstone of next-generation cancer immunotherapy, speed and quality are critical to success. With multi-virus platform capabilities, standardized workflows, and experienced scientific and project teams, Creative Biogene provides integrated support covering discovery, validation, regulatory submission, and GMP manufacturing. Whether you are in early-stage research or clinical development, we offer flexible, efficient, and compliant solutions to take your pipeline from bench to bedside. Contact Creative Biogene today to start your oncolytic virus translational journey!
Q1: Is oncolytic virus therapy safe? What are the potential side effects?
A1: Oncolytic virus therapy has demonstrated a favorable safety profile with generally mild and controllable side effects. Common adverse events include localized reactions at the injection site (pain, redness, swelling) and flu-like symptoms such as low-grade fever and fatigue, which typically resolve on their own. These safety characteristics stem from careful viral engineering that attenuates virulence and ensures selective replication in tumor cells, minimizing effects on normal tissues. Extensive clinical trial data support the safety of this therapeutic approach.
Q2: What are the specific GMP manufacturing requirements for oncolytic viruses?
A2: GMP production of oncolytic viruses requires stringent quality standards and regulatory compliance. Manufacturing must be performed in GMP-certified cleanrooms with rigorous contamination control and environmental monitoring systems. Comprehensive batch records and full traceability are essential. Standardized cell banks and virus seed stocks must be established, with serum-free suspension culture processes preferred. All steps of viral infection, harvesting, and purification must be tightly controlled, and a thorough QC testing regime must be implemented. The entire process must occur in a controlled environment to ensure product consistency and reproducibility.
Q3: How is product quality and consistency ensured for oncolytic virus products?
A3: Product quality is assured through a multi-layered QC system. Identity verification includes Western blotting for protein expression, electron microscopy for structural integrity, and neutralization assays for serotype confirmation. Potency testing includes genome titer analysis via qPCR and infectious titer assessment by plaque assays, along with evaluations of biological activity and tumor-killing efficacy. Safety testing includes sterility, mycoplasma, and impurity detection (e.g., HCP, residual DNA). These comprehensive controls ensure batch-to-batch consistency and compliance with clinical safety standards.
Q4: How are project timelines and costs evaluated?
A4: Project timelines and costs depend on virus type and complexity, production scale, number of batches, quality requirements, and development stage. Typically, process development takes 3–6 months, analytical method development 2–4 months, GMP production 2–4 months, and QC and release testing 1–2 months. Research-grade projects are more economical, while clinical- and commercial-grade production incurs higher costs. Early consultation with CDMO partners is advised to obtain tailored evaluations. A phased collaboration approach is also recommended to mitigate risks and establish long-term strategic partnerships for better service quality and pricing.
Copyright © Creative Biogene. All rights reserved.
