Within our integrated Pharmaceutical Development & Manufacturing capabilities, we deliver phase-appropriate Drug Substance Development programs tailored to nucleic-acid modalities. Under Gene Therapy Vector Development, our adenoviral vector development offering focuses on research and development activities that shape robust, scalable, and compliant paths from concept to manufacturing readiness.
Overview of Adenoviral Vector
Adenoviral vectors are non-enveloped, double-stranded DNA platforms that accommodate sizeable genetic payloads and support transient expression. Replication-defective backbones (e.g., E1/E3-deleted) and helper-dependent "gutless" formats minimize viral gene expression while preserving high-titer production in qualified cell substrates. For pharmaceutical use, development emphasizes genetic integrity, reduction of replication-competent adenovirus (RCA), efficient upstream yields, impurity control, and stability under storage and handling conditions common to drug substance operations. Analytical frameworks typically quantify physical particles, functional infectivity, genome integrity, capsid identity, process-related impurities, and residual DNA/protein, all under method life-cycle management suitable for advancing through research and into regulated manufacturing.
Our Services
We provide an end-to-end, R&D-focused service suite. Programs are modular yet cohesive, enabling rapid technical iteration and clear decision points before scale-up.
Vector Design & Construct Engineering Service
We design adenoviral transfer constructs and helper systems with attention to payload size, regulatory elements, and backbone selection (first-/second-generation or helper-dependent). Main tasks include promoter/enhancer selection, polyA optimization, intron usage, and cassette architecture to balance expression kinetics with manufacturability. We verify sequence integrity, payload orientation, restriction maps, and in-silico risk flags (e.g., recombination-prone repeats), delivering annotated plasmids and design reports suitable for tech files.
Producer Cell Substrate & Production System Development Service
We qualify research-scale cell substrates (e.g., E1-complementing lines) and define transfection/infection strategies, MOI settings, and harvest windows. Early studies focus on media selection, feed strategies, multiplicity optimization, and shear protection in shaker flasks and benchtop bioreactors. We document cell bank lineage, passage history, and acceptance criteria to facilitate later transfer to GMP-compliant banks without altering critical quality attributes.
Upstream Process Development Service
We establish scalable upstream conditions for adherent or suspension systems, including bioreactor set-points (pH, DO, temperature), feed/induction schemes, and residence times that maximize functional particle output. Design-of-experiments (DoE) defines operating ranges and identifies interactions among key factors. We generate transfer-ready process descriptions, bill-of-materials, and risk-based in-process controls (e.g., viability, glucose/lactate, viral productivity surrogates).
Downstream Purification
Chromatography-driven recovery strategies (e.g., AEX/MCX/TFF combinations) are developed to achieve high purity while maintaining infectivity. We profile the removal of host-cell proteins/DNA, helper residues, empty or damaged particles, and process reagents.
Analytical Development & Quality Attribute Service
We build an attribute-driven analytical package: genome titer by qPCR/ddPCR, infectious titer by cell-based readouts, particle concentration by optical/biophysical methods, identity by capsid protein mapping, purity by SDS-PAGE/HPLC-AEX, and residuals (host DNA/protein, benzonase, detergents) by targeted assays. We design RCA detection and acceptance-rule logic suitable for development phases, with method qualification, system suitability, reference standards, and trending plans to support lifecycle control.
We design, characterize, and de-risk adenoviral vectors with process-ready science, attribute-driven analytics, and stability-minded formulations. Our R&D services translate concepts into robust drug-substance candidates under a platform that anticipates seamless progression to later manufacturing stages. Contact us to initiate a targeted development plan.
Our products and services are for research use only.
