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GMP Grade Viral Service

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In the rapidly evolving field of gene and cell therapy, viral vectors are the core delivery tools that directly impact the safety, efficacy, and clinical viability of advanced therapies. Backed by years of technical expertise and dedicated GMP-compliant infrastructure, Creative Biogene has established an integrated, end-to-end GMP viral vector CDMO platform. This platform supports lentivirus, retrovirus, adenovirus, and adeno-associated virus (AAV) production, providing complete lifecycle support from process development to GMP-grade production and regulatory submissions.

Platform Overview and Strategic Positioning

Our GMP-grade viral vector platform is designed to meet global regulatory expectations, including those of the FDA, EMA, NMPA, and WHO. Facilities are equipped with ISO 5–7 (Grade A–C) cleanrooms under BSL-2 compliance, supporting both adherent and suspension-based manufacturing systems. With upstream bioreactor capacities up to 200 L and downstream aseptic fill-finish capabilities, we operate a fully closed and traceable production system with comprehensive documentation, including batch manufacturing records (BMR), certificates of analysis (CoA), and method validation reports.

We offer three distinct production grades tailored to each development phase:

  • Research-Use Only (RUO): For early-stage in vitro and in vivo functional testing.
  • GMP-like: Ideal for pharmacology and toxicology studies with controlled document systems.
  • GMP-grade: Fully compliant with regulatory expectations for IND/CTA submissions and late-phase clinical or commercial use.

PRECLINICAL

IND

CLINICAL TRIALS

BLA

COMMERCIAL

  • Custom LVV / AAV / RVV/ADV packaging systems
  • Plasmid production
  • PCB / MCB / WCB establishment
  • Process & analytical method development
  • Early stability study
  • GMP plasmid manufacturing
  • GMP virus DS / DP production
  • Aseptic fill & finish
  • Full QC release testing
  • In-process controls (IPC)
  • Long-term & accelerated stability studies
  • Process characterization (PC)
  • Process validation (PPQ)
  • Method validation (ICH Q2)
  • GMP manufacturing at scale
  • Regulatory documentation (BMR, CoA, CTD)
  • Commercial supply readiness

Research-grade

GMP-like

GMP-grade

Vector Types

GMP Lentivirus Production Service

Lentiviruses are enveloped RNA viruses capable of integrating into the host genome, offering stable, long-term expression even in non-dividing cells. With high packaging capacity (~8–10 kb), they are suitable for delivering large payloads, CRISPR/Cas systems, and multicistronic constructs. They are widely used in CAR-T, NK cell therapies, iPSC editing, and gene modulation studies.

cGMP AAV Manufacturing

Creative Biogene supports multiple serotypes including AAV2, AAV5, AAV8, AAV9, and engineered variants. Production is conducted in HEK293 suspension cultures, with scalable output up to 1017 GC per batch. Downstream processes include affinity chromatography, ion exchange, and density gradient centrifugation.

cGMP Retrovirus Production

Retroviruses, especially γ-retroviruses like MMLV and MSCV, remain valuable for gene modification in dividing cells such as HSPCs, T cells, and tumor cell lines. These vectors integrate into host DNA, making them suitable for long-term, stable gene expression. We support PG13-derived packaging cell systems with stable expression and MSCV vectors optimized for stem cells, offering resistance to epigenetic silencing and enhanced expression in iPSCs and ESCs.

cGMP ADV Production

Creative Biogene provides both replication-defective and helper-dependent (gutless) adenoviral vectors. Our platform supports scalable production in HEK293 or PER.C6 suspension systems with advanced purification strategies including CsCl gradient, chromatography-based methods, and ultrafiltration.

Modular GMP Manufacturing Capabilities

Creative Biogene provides a flexible and robust GMP production ecosystem, segmented into functional service modules.

Starting Materials and Cell Banks

  • GMP-grade plasmid manufacturing with antibiotic-free and animal component-free options
  • Master and working cell bank (MCB/WCB) establishment with full genetic and safety profiling
  • Producer cell line development for retroviral production consistency

Process Development and Scale-Up

  • Transfection and culture optimization, harvest timing, and nutrient modulation
  • Adherent and suspension systems: Cell Factory, fixed-bed bioreactors, and 200 L single-use systems
  • Downstream purification: PEG precipitation, TFF, affinity/IEX/mixed-mode chromatography
  • Aseptic filling in 2R–15R vials with speeds up to 2400 vials/hour

Quality Control and Analytical Development

Aligned with regulatory standards, we provide a comprehensive QC suite:

QC CategoryTest Item / MethodPurpose / Regulatory Relevance
Identity & ExpressionVector sequencing, qPCR, GOI expression (qPCR, ELISA, WB)Confirm vector structure, payload, and functional expression
PotencyTiter (qPCR, ddPCR, TCID50, FACS)Determine infectious and genomic titers
PuritySDS-PAGE, HCP (ELISA), residual DNA/proteinEvaluate impurities and downstream processing efficiency
SafetySterility (USP<71>), Mycoplasma (qPCR/culture), Endotoxin (LAL), RCL/RCREnsure viral safety and biosafety compliance
StabilityAccelerated and long-term testingDefine shelf life and storage conditions
Analytical ValidationSpecificity, accuracy, linearity, robustness (ICH Q2)Support regulatory submissions and batch consistency

Documentation and Regulatory Support

Understanding the criticality of documentation, we provide full submission-ready packages:

  • BMRs, CoAs, method validation summaries
  • CTD-compliant documentation (Module 3)
  • IND/CTA filing support and regulatory Q&A assistance

PROJECT MANAGEMENT

Regulatory Alignment

Our multidisciplinary team of molecular biologists, bioprocess engineers, QA/QC experts, and regulatory professionals ensures every client project is managed with precision and transparency. We've passed dozens of client and third-party audits, adhering to FDA, EMA, NMPA, and WHO standards, with 100% audit satisfaction.

Clinical Milestone Support

Preclinical

RUO or GMP-like batches for in vivo pharmacology and safety studies

IND/CTA

GMP-grade vectors with full CMC data for early-phase clinical trials

Commercialization

Process characterization (PC), PPQ, and BLA/MAA dossier support

Empowering Therapeutic Innovation

As a trusted partner in viral vector manufacturing, Creative Biogene is committed to delivering scalable, high-quality, and regulatory-compliant solutions to advance gene and cell therapies from bench to bedside. Every vector we produce carries not only scientific innovation but the hope for real-world patient outcomes.

Whether you're launching a discovery-phase study or preparing for clinical submission, our team stands ready to support your success with flexible solutions, expert guidance, and manufacturing excellence.

FAQ

Q: How does Creative Biogene ensure regulatory alignment across FDA, EMA, and NMPA requirements?

A: Our quality system is built upon global standards including ICH Q7, ICH Q5A, and FDA 21 CFR 210/211, ensuring full compliance for U.S., EU, and China submissions. All process documents, analytical methods, and batch records are prepared in eCTD-ready formats. We have extensive experience supporting IND, CTA, and IMPD filings for both AAV and LVV platforms, and provide Module 3 authoring along with regulatory response services. Our embedded QA team facilitates customer quality verification (CQV) and supports flexible change control, on-site audits, and timely response to regulatory inquiries.

Q: How do you ensure a seamless transition from preclinical to GMP manufacturing?

A: We implement a staged capacity model tailored to clinical progression—≤50L for preclinical (adherent system), 50–200L for early trials (single-use bioreactors), and ≥200L for late-stage or commercial production (suspension platform with GMP fill-finish). All viral vector platforms adopt standardized suspension-based processes, with scalability parameters validated in advance. Our dedicated teams oversee process characterization (PC) and PPQ with typical timelines of 8–10 months. In addition, our internal plasmid platform ensures critical raw materials are supplied in-house, and dual-sourcing strategies mitigate global supply risks.

Q: Is Creative Biogene financially stable enough to support long-term projects?

A: Yes. Creative Biogene operates independent R&D and GMP manufacturing facilities across North America and Asia. We deliver over 100 GMP viral vector batches annually, serving top-20 pharmaceutical companies and innovative biotechs. Our integrated service model spans plasmid production, cell banking, viral vector manufacturing, and CMC support, with a client retention rate exceeding 70%. We maintain active legal, QA, and risk control teams, and offer business continuity protections in all contracts to ensure delivery consistency and project security.

* For research use only. Not intended for any clinical use.
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