Viral Vector CDMO Solutions
From plasmid to aseptic fill-finish — GMP manufacturing for AAV, Lentivirus, Adenovirus, HSV & more, aligned with FDA/EMA expectations.
End-to-End Partner for Your Vector Program
Creative Biolabs provides a single, accountable CDMO partner from initial vector design and optimization, through high-quality plasmid production, comprehensive upstream/downstream process development, rigorous analytics, and scalable GMP manufacturing, culminating in aseptic formulation and fill-finish. This fully integrated model eliminates complex handoffs and ensures seamless knowledge transfer. Our platform templates and phase-appropriate quality systems reduce risk, compress timelines, and simplify CMC planning for your IND/BLA submissions.
We support a complete range of viral modalities, including AAV, LVV, Adenovirus, and HSV, utilizing robust producer systems that span HEK293 (adherent/suspension) and baculovirus/Sf9 for AAV. With dedicated expertise in robust assay development, stability programs, and comprehensive regulatory documentation support, we are positioned to help you meet critical milestones with clarity, confidence, and a clear path toward regulatory approval.
Viral Vector Modalities We Support
Platformized, phase-appropriate development and GMP manufacturing for leading vector systems.
AAV (Adeno-Associated Virus)
- Serotypes: AAV2/5/6/8/9, rh10, DJ, PHP variants
- HEK293 transient & Sf9-baculovirus platforms
- Empty/Full control & orthogonal analytics (AUC/TEM)
- GC/mL titering, capsid ELISA, potency assays
Lentivirus (LVV)
- 2nd/3rd-gen systems; VSV-G & alternative envelopes
- Suspension HEK293 and stable producer options
- TU/mL infectivity assays, vector copy control
- CAR-T and ex vivo applications ready
Adenovirus (AdV)
- E1/E3-deleted, helper-dependent, oncolytic constructs
- Robust downstream & impurity clearance
- Potency readouts tailored to MoA
- Scalable, phase-appropriate templates
HSV
- Oncolytic and gene delivery programs
- Potency assays & tailored analytics
- Vector genome integrity by qPCR/dPCR/NGS
- GMP fill-finish & cold-chain logistics
Key Application Areas
Comprehensive Service Scope
From plasmid and producer systems to analytics, formulation, and GMP fill-finish — all under one roof.
Plasmid & Vector Engineering
- Codon optimization, promoter/enhancer selection, ITR/signals integrity
- HQ/GMP plasmid production with full release panel
- Sequence verification and liability assessment
- Tech transfer & gap analysis for existing vectors
Upstream Process Development
- HEK293 (adherent/suspension), stable producers; Sf9-baculovirus for AAV
- Batch, fed-batch, perfusion strategies (2–500 L SUS)
- CPP/CQA mapping, DoE screening, scale-down models, PAT
- MCB/WCB creation & characterization
Downstream Purification
- Clarification, nuclease treatment, TFF concentration/diafiltration
- Capture/polish: AAVX/serotype ligands, IEX, SEC
- Empty/Full strategies for AAV (AEX, density gradients)
- Impurity clearance: HCP, HCDNA, residuals (nuclease, detergents)
Analytical Development & QC
- Identity: capsid proteins (LC-MS), genome integrity (qPCR/dPCR/NGS)
- Potency: TU/mL (LVV), GC/mL (AAV), cell-based transduction
- Particle quality: empty/full (AUC-SV, TEM), aggregation (DLS/SEC-MALS)
- Safety: endotoxin, sterility, mycoplasma, adventitious agent testing
Formulation & Fill-Finish
- Buffer/cryoprotectant/surfactant screening with stability-indicating methods
- Aseptic vialing (2R–10R; prefilled syringe optional)
- Filter integrity, labeling/serialization, cold-chain logistics
- Real-time/accelerated stability programs
Regulatory & CMC Documentation
- IND/IMPD authoring support, CoA, batch records, method validation reports
- Comparability protocols, risk assessments, CPV/PPQ planning
- Client audit support & secure data rooms
Platforms & Templates
Proven, serotype- and backbone-agnostic templates to de-risk scale-up and accelerate release.
AAV Platform
HEK293 transient & Sf9-baculovirus; serotype-agnostic capture and robust empty/full control.
- AAVX/serotype ligands, AEX/SEC polish
- Orthogonal characterization (AUC/TEM/ELISA)
- Scale-down models mapped to 50–500 L
LVV Platform
Suspension HEK293 with stable producer options for higher TU/mL and process robustness.
- Envelope options beyond VSV-G
- Cell-based potency & vector copy control
- Closed processing for biosafety
AdV & HSV Templates
Established purification frameworks and tailored potency readouts.
- Impurity clearance strategies
- Oncolytic construct compatibility
- Flexible release testing menus
Raw Materials Strategy
Vendor qualification, AOF media, lot-to-lot bridging, and data integrity (ALCOA+).
- Closed single-use systems
- Change control & deviation/CAPA
- Audit-ready documentation
Manufacturing Scales & Assay Menu
Phase-appropriate manufacturing from research to clinical GMP, supported by a full suite of orthogonal analytics.
Research-Grade
2–20 L ScaleFor feasibility studies, early proof-of-concept, and rapid iteration. Core analytics provided.
GMP-like
50–200 L ScaleFor toxicology studies and engineering runs. Uses closed-system mapping and draft MBRs.
GMP Clinical
50–500 L ScaleFor Phase I–III clinical supply. Includes full QC release panel, QA oversight, and stability programs.
Comprehensive Assay Menu
Identity
- Capsid proteins by LC–MS / peptide mapping
- Vector genome integrity (qPCR/dPCR, NGS)
Potency
- AAV GC/mL, cell-based transduction
- LVV TU/mL, flow cytometry readouts
Purity & Safety
- HCP/HCDNA, residual nuclease/detergents
- Endotoxin, sterility, mycoplasma
Particle Quality
- Empty/Full (AUC-SV, TEM)
- Aggregation (DLS, SEC-MALS)
End-to-End CDMO Workflow
A transparent, phase-gated path from feasibility to GMP drug product and stability.
| Stage | Services | Key Technologies & Readouts |
|---|---|---|
| Discovery/Feasibility | Initial titer & quality proof points | Small-scale production, core analytics, risk mapping |
| Process Development | Upstream/Downstream/Analytics packages | DoE, CPP/CQA mapping, robustness studies |
| Engineering Runs | Scale verification & draft MBR | Closed-system mapping, yield/purity balance |
| GMP Campaign | Batch execution & QC release | SUS bioreactors (50–500 L), compliant documentation |
| Fill-Finish & Release | Aseptic vialing & stability program | Filter integrity, real-time/accelerated stability |
| CMC & Regulatory | IND/IMPD authoring, CoA/MBR, validation reports | Comparability, PPQ/CPV planning, audit support |
Facilities & Quality Systems
Our state-of-the-art facilities feature fully segregated BSL-2/2+ suites with unidirectional personnel/material flows and dedicated air handling systems to eliminate cross-contamination risk. We operate on a fully single-use-system (SUS) platform, from upstream bioreactors to downstream purification skids, ensuring process flexibility and robust containment. Our Quality Management System (QMS) is rigorously aligned with global cGMP standards, including ICH Q8 (Pharmaceutical Development), Q9 (Quality Risk Management), and Q10 (Pharmaceutical Quality System). This framework governs all operations, including our robust deviation/CAPA processes, stringent change control, comprehensive data integrity (ALCOA+) policies, full equipment (IQ/OQ/PQ) and utility qualification, phase-appropriate method qualification/validation, and computer system validation (CSV).
Aseptic process integrity is maintained through continuous environmental monitoring (viable/non-viable particles), rigorous operator gowning qualification, and comprehensive cleaning validation protocols, all designed to ensure batch-to-batch consistency and product safety. We provide complete, audit-ready documentation packages, including batch records, validation reports, and raw material specifications. Our dedicated QA team actively supports client audits and provides transparent, expert support for all regulatory interactions and submissions.
cGMP COMPLIANT
ISO 9001 CERTIFIED
FDA / EMA READY
IND/IMPD SUPPORT
The Creative Biolabs Advantage
High titers at scale, platform templates, and clear CMC paths that de-risk development.
End-to-End Integration
From GMP-grade plasmids and process development through GMP manufacturing, analytical release, formulation, and aseptic fill-finish. One accountable team minimizes handoffs, reduces timelines, and ensures seamless knowledge transfer.
Platformized Speed
Leverage our optimized, serotype/backbone-agnostic platform templates, pre-qualified raw materials, and established scale-down models to accelerate your program from concept to clinic, faster.
High Titer at Scale
Our proprietary, optimized suspension HEK293 and Sf9 processes are designed for scalability, consistently delivering high-volume, high-titer yields without sacrificing critical product quality attributes like empty/full ratios.
Transparent PM
You are assigned a dedicated PhD-level Project Manager who acts as a single point of contact. We provide clear weekly updates, detailed Gantt chart snapshots, and proactive risk/mitigation registers to ensure full transparency.
Phase-Appropriate Quality
Our QMS is built for flexibility, applying the right level of cGMP rigor at the right time. We ensure a 'right-first-time' mindset from non-clinical feasibility through commercial-readiness and PPQ planning.
Seamless Scalability
Our processes are designed with the end in mind. We provide clear scale-down model correlation and robust process characterization (CPV) planning to ensure your bench-scale process is identical to the 500 L GMP run.
What Our Partners Say
Real feedback from gene therapy and cell therapy teams.
★★★★★
“Creative Biolabs’ AAV9 platform was a game-changer. They systematically optimized the downstream process, cutting our empty capsids from ~60% down to ~20% and improving our *in-vitro* potency by 3-fold. The tech transfer package was the cleanest our QA department has ever seen.”
★★★★★
“We needed to scale our LVV vector for a CAR-T program. Their team successfully moved our process from adherent to suspension and saw a 5–6× improvement in TU/mL. Their clear weekly reporting and strong assay validation gave our IND a smooth ride with no CMC questions.”
★★★★★
“The fill-finish and stability program was handled flawlessly, end-to-end. Their team’s proactive planning for labeling and serialization, integrated with cold-chain logistics, saved us weeks of headache ahead of our critical Phase I First-Patient-In (FPI) milestone.”
Frequently Asked Questions
Quick answers to the most common CMC and manufacturing questions.
What vector scales and yields can you support?
Our manufacturing scales are phase-appropriate. Development runs are typically conducted at the 2–20 L scale for process optimization. Our GMP-like engineering runs and full cGMP clinical campaigns range from 50 L to 500 L using single-use bioreactors (SUS), with straightforward options for parallelization to meet higher demands. Titers are highly dependent on the vector, serotype, and payload; we provide detailed, serotype-specific platform benchmarks during the project scoping phase.
How do you separate AAV empty and full capsids?
We employ a multi-step, orthogonal strategy. Our platform capture step utilizes AAVX or serotype-specific affinity ligands, which provides initial separation. This is followed by a polishing step, typically involving Anion-Exchange (AEX) or Size-Exclusion (SEC) chromatography. For programs requiring extremely high purity, we also offer phase-appropriate density gradient ultracentrifugation (iodixanol/CsCl). Most importantly, we verify the empty/full ratio using gold-standard orthogonal methods, primarily Analytical Ultracentrifugation (AUC-SV) and Transmission Electron Microscopy (TEM).
Do you support client-supplied assays and raw materials?
Yes, absolutely. Our preference is to be a full-service partner, but we routinely tech-transfer client-developed assays. Our analytical development team will qualify or, if required for late-phase, fully validate your methods. We can also perform comparability studies against our platform methods and integrate your qualified assays and raw materials into the overall control strategy and release panel.
Can you assist with IND/IMPD authoring and agency Q&A?
We provide comprehensive CMC documentation support. This includes authoring the relevant CMC sections for your IND/IMPD submission, providing all executed batch records, validation reports, and Certificates of Analysis (CoA). Our QA and technical teams also prepare secure data rooms for agency review and provide rapid, expert responses to any agency queries related to process justification, control strategies, impurity clearance, and stability plans.
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