FAQ

Frequently asked questions & troubleshooting guides

Technical

 

What cell types have been validated with the µVS Delivery System™?

Activated primary human T cells. Delivery to additional cell types is on our roadmap.

What constructs have been validated with the µVS Delivery System™?

Various mRNA constructs (1 - 1.8kb) , DNA nanoplasmid, and Cas9-ribonucleoproteins (Cas9-RNPs). Co-delivery of mRNA and DNA constructs and transfection of additional Cas9-RNP complexes is currently being explored.

What is the optimal pressure for the use of the µVS Delivery System™?

The optimal pressure is 120 PSI for recently activated primary human T cells.

Can we change the volume of cells that we want to transfect (ex: 20 µl of cell sample)?

Optimal processing volumes and concentrations will vary depending on cell type and construct. Therefore, we recommend titrating volumes (50 µl to 1ml), cell concentration (10M to 50M cells/ml), and construct concentration to identify optimal transfection conditions. We recommend processing volumes of at least 100 µl.

What is the range of cell concentrations in which we can transfect our cell samples?

10M/ml to 50M/ml is the range of cell concentrations we recommend. 50M/ml is the concentration that produces the highest transfection efficiency. Lower transfection efficiency may be observed when transfecting at concentration less than 50M/mL.

Are there any recommendations to improve cell recovery at 24 hours?

This is more essential for nucleic acids as opposed to protein or protein-based complexes. For nucleic acids like mRNA, we recommend adding DNAse (12.5U/ml) to samples after transfection to maximize cell recovery at 24 hours post-transfection. The addition of DNAse is not essential for the transfection of protein or protein-based complexes (i.e. Cas9-RNPs).

What is the maximum number of cells that can be processed per device?

We recommend processing no more than 50 million cells per device. The µVS Delivery System is amenable to various cell concentrations (1M to 50M cells/ml) and processing volumes (≥100µl).

Should compressed nitrogen, air, or carbon dioxide be used with this device?

We recommend compressed nitrogen since it is an inert gas. We have compared processing with compressed air to nitrogen and see comparable results. However, we do not recommend the use of compressed carbon dioxide, as delivery can directly affect pH levels in transfected cell suspension and negatively impact cell viabilities along with the overall health of transfected cells.

The filtration step avoids clogging, but that results in 50% drop of the cells. Is this a necessary step?

Yes, between 30-50% of cell loss can occur after filtering through a 40-micron filter, depending on the donor. However, filtering is a critical step and can not be skipped for optimal use of the µVS Delivery System™.

Early Access

 

Can I use the µVS Delivery System™ in my lab?

Indee Labs offers Early Access to the µVS Delivery SystemTM via a paid 3- to 6-month Equipment Lease Agreements to academic labs, biotechnology startups, and pharmaceutical companies. The Equipment Lease Agreement includes a complete jig setup, all sub-assembly components (i.e. sterile tubing, fittings), a pressure regulator (for compressed nitrogen gas), and sufficient µVS devices to start experiments. The end user needs only supply high purity compressed nitrogen (Airgas or Praxair). As part of an Equipment Lease Agreement, end users will have access to Indee Labs scientists, technicians, and data analysis tools to aid in experimental optimization(s). Indee Labs requires an upfront payment to ship the µVS instrument setup, and then provides standard operating procedures (SOPs) and related protocols. The upfront payment is inclusive of the fees required to support scientist and technician time over the duration of the Equipment Lease Agreement. Early Access customers also receive the option to purchase the equipment for internal research purposes at any point in time during the Lease. Please contact us to review our standard Equipment Lease Agreement.

Can I contract Indee Labs to perform services using the µVS Delivery System™ on my project?

Indee Labs offers full-service support to academic labs, biotechnology startups, and pharmaceutical companies. Another standard offering is a Master Research Agreement, which includes 1.0 (or more) full-time employees (FTE's) on your project for 12 months along with the relevant technical and project management support. Additional projects can be easily added to a Master Research Agreement. The Master Research Agreement may be in addition to an Equipment Lease Agreement. Projects can be scoped to include bi-monthly meetings, development milestones, and success criteria. While the goal of the project may naturally segway into out-licensing of the µVS Delivery System™ for clinical development, the versatility of the µVS approach can be applied to a wide variety of (human or other) cell types, non-viral vectors, gene editing construct(s) and workflows (discovery, preclinical, clinical and/or commercial).

Is the µVS Delivery System™ cGMP compliant for use in clinical development program?

The µVS Delivery System™ will be regulated as a tool for biologics manufacturing for clinical and commercial use. Regardless of the application, the µVS Delivery SystemTM is made from USP Class VI implantable or FDA grade materials and with an ISO 13485 compliant industrial designer. A technical manual and qualification document(s) are available for installation of the µVS Delivery System into a cGMP cleanroom environment. Medical grade compressed nitrogen is required to operate the µVS Delivery System™ within a cleanroom environment. Clinical-grade µVS devices will include a Certificate of Conformance (CoC), and an Extractable & Leachable (E&L) testing certificate for Investigational New Drug (IND) submissions and to support documentation for clinical manufacturing of gene-modified cell therapies such as T cell immunotherapies.

How can I order more µVS devices, instruments and parts?

All µVS devices, sub-assembly components, tubing and fittings to support in-house transfections can be sourced directly from Indee Labs. We are committed to maintaining a robust inventory of µVS instruments, µVS devices, and sub-assembly components to support all end users.

How can I use Indee Labs’ non-viral transposon/transposase system for my optimization work?

Indee Labs is developing an open source, non-viral transposon/ase system for use with the µVS Delivery System™. We can use a Master Research Agreement to work with your organization, and integrate this system into your development program(s). Included in this research offering is ordering, optimization, data analysis, routine meetings, and project management support from Indee Labs’ scientists, technicians and project managers.

Can I access Indee Labs’ data science efforts to enhance our internal development using the µVS Delivery System™?

Indee Labs has developed a series of computational fluid dynamics simulations along with an proprietary experimental database that helps use glean key information about our development efforts while also improving our protocol optimization. We’d be more than happy to chat about adding this into any Master Research Agreement(s) and related Project Proposal(s).

Downloads

First Protocol - Coming Soon

Cleaning Protocol - Coming Soon

FAQs & Troubleshooting

Certificate of Conformance - Coming Soon

Technical Manual - Coming Soon

Qualification Document - Coming Soon

Send us a message!

Have a question about our product or business? Ask us.