Lead vector design is a critical step in the development of effective lentiviral gene delivery systems for cell therapy applications. Optimizing vector architecture early helps achieve the right balance of transduction efficacy, transgene expression, cell-type specificity, safety, and manufacturability. Thoughtful design reduces development risk, improves the likelihood of clinical success, and accelerates the path from discovery to the clinic for both ex vivo and in vivo cell therapy programs.

DINAMIQS recommends starting each project with a thorough lead vector inspection and offers vector optimization capabilities around:

• AI guided cassette engineering including the gene of interest, regulatory elements, plasmid backbone, and others
• Functional validation and optimization in small scale experiments
• IP landscape screening

Robust process development is essential for translating a promising lentiviral vector into a scalable, reproducible therapeutic product. By optimizing upstream production, downstream purification, and analytical methods early in development, manufacturers can improve vector quality, maximize yield, and establish a process that supports regulatory compliance and successful clinical and commercial manufacturing.

DINAMIQS’ process development (PD) capabilities start with Design of Experiments (DoE) driven parameter optimization, reproduced in small scale up to process robustness verification in 2L.  In-process controls will be applied to monitor process performance and support development activities.

In detail this includes:

• Upstream process (USP) optimization: The vector feasibility study.

Identify optimal manufacturing conditions with the aim of maximizing both vector yield and product quality. This will be achieved through a structured DoE approach evaluating key critical process parameters (CPPs), including plasmid ratios, total DNA amount, transfection reagents, enhancers and /or other parameters. Best performer conditions will be reproduced on a small scale with robustness verification in 2L bioreactors.

• Downstream process (DSP) optimization:

Advance DSP development, with a focus on key unit operations including filtration, flow through mode and ion exchange (IEX) chromatography.  Attention will be given to key manufacturing drivers for viral vectors with yield, recovery, final titer, purity, and capacity including scalability.

The evaluation focuses on the implementation of a scalable downstream process integrating clarification, tangential flow filtration (TFF), and mixed-mode chromatography to enable purification, concentration, and formulation of LV vectors for ex vivo and in vivo applications.

The assessment will measure vector recovery across unit operations, while evaluating the clearance of process-related impurities.

High-quality preclinical-grade lentiviral vector material is essential for generating reliable in vitro and in vivo proof-of-concept, biodistribution, and safety data before clinical development. Producing material with a well-characterized, scalable process enables meaningful preclinical studies while providing a strong foundation for a smooth transition into GMP manufacturing and first-in-human clinical trials.

At DINAMIQS, we work in suspension only with single use technology and GMP compatible raw materials early in the process. Our harmonized infrastructure across different scales guarantees a seamless scale-up from small scale via 2L up to 50L.

High end DSP capabilities, including a combination of chromatography and tangential flow filtration (TFF) based techniques, guarantee supply of LV material with the highest possible quality and safety standards.

Preclinical manufacturing services at DINAMIQS include:

• Small scale manufacturing for in vitro/ in vivo proof of concept studies
• Comparison studies for companies moving from adherent to suspension culture
• Material supply for ex vivo cell therapies
• Material supply for in vivo cell therapies up to 50L

From early clinical studies to commercial supply, robust GMP manufacturing is essential for delivering high-quality lentiviral vectors for cell therapy applications. Our integrated capabilities span both drug substance (DS) and drug product (DP) manufacturing, including on-site fill-finish, enabling a seamless transition from vector production to the final sterile product. By keeping critical manufacturing steps under one roof, we reduce technology transfer risks, streamline timelines, and help ensure a reliable supply of lentiviral vectors for both ex vivo and emerging in vivo cell therapy programs.

DINAMIQS’ cGMP capabilities include:

• Manufacturing from 20L – 1000L
• Fully closed, single use systems, suspension only
• Annex 1 compliance
• On-site fill-finish
• Fully portable processes, no IP/ vendor lock-in
• Flexibility in critical raw materials (e.g. plasmids/ cell lines)
• Regulatory support by >30 regulatory experts

DINAMIQS offers a comprehensive suite of assays for the characterization of LV products, fully aligned with regulatory requirements. All assays to characterize critical quality attributes (CQAs), identity, purity, potency, strength and safety are performed in-house, ensuring speed, consistency, and quality. These analytical services are also available as stand-alone solutions, supporting customers who require dedicated characterization, testing or method development capabilities.

DINAMIQS performs product specific analytical method development, implemented and optimized in DINAMIQS laboratories to support process establishment and to prepare for subsequent GMP qualification activities.

DINAMIQS’ in-house fill-finish solution is a semi- automated SKAN Pure isolator technology equipped with AT Filler Crystal® Pure M1, designed for aseptic vial filling. The technology is specifically well suited for small batches of viral vector DP manufacturing. The isolator is installed in class C environment.

1. Dedicated to small batches, designed for novel therapies such as Viral Vectors
2. Semi-automated AT-Closed Vial® filling
3. Filling format from 1mL to 50 mL vials, 2 mL format qualified
4. AT Vials, specially designed ready-to-fill COC vial