Scientific, technical and regulatory support

At MaxCyte^®, we know that bringing a therapy to market requires more than innovative technology. It requires the know-how of experienced professionals to help navigate challenges along the way. This is why our team works closely with our partners, leveraging our technical and regulatory expertise to help chart your best course forward from discovery to commercialization.

Innovate confidently with expert scientific and technical support

We take a collaborative approach to problem-solving by sharing our wealth of scientific expertise across a broad range of application areas to ensure your success.

Our global teams provide on-site and remote support worldwide. Starting with platform training, through cell engineering process optimization and troubleshooting, our application scientists are with you every step of the way. Our technical support includes instrument installation, IQ/OQ verification and maintenance as needed.

Diverse application experience includes:

Immunology
Gene editing
Recombinant protein expression
iPSC and stem cells culture and differentiation
Mammalian cell culture
Process development
Viral vectors
Vaccines
Cell-based assays

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Our team of field applications scientists are at the ready

Andrew shares how his collaboration with a cell-therapy developer led to a 90% efficiency boost, enabling the developer to confidently proceed with clinical manufacturing.

Hear from Andrew

Hear how Megan identified a critical flaw in the technology transfer process from a customer to a CDMO. Her swift action ensured a timely resolution and improved standard operating procedures.

Hear from Megan

Hear from Joan as she shares how her dedication and scientific expertise helped a stealth mode cell therapy company overcome a critical challenge and successfully reach their next inflection point.

Hear from Joan

Listen to Peter go through how he helped a partner overcome challenges in scaling up their cell therapy process using our large-scale electroporation platform, so they could produce and cryopreserve one batch for multiple doses.

Hear from Peter

Advance efficiently with experienced regulatory support

With comprehensive geographic coverage, flexible filing support, and a US FDA master file that has been continuously updated since initial filing in 2002, our regulatory team has over 20 years of experience to support you as you chart a course through approval processes.

Our customers have completed successful fillings with agencies in several countries including:

Canada
Australia
Switzerland
UK
Austria
Belgium

France
Germany
Italy
Netherlands
Spain
Japan
Singapore

We have a US FDA master file that streamlines the regulatory submission process and includes all components intended for use in GMP-compliant manufacturing—instrument, buffer and processing assemblies.

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Clinical Trials

From INDs referencing
MaxCyte’s US FDA master file

We have the flexibility to support your regulatory submission with the information that best meets the needs of your specific filing, whether it’s an IND, CTA or marketing application.

We can:

Reference existing master or technical files
Provide customized documentation to submit special purpose technical files or to interact with a regulatory agency as needed

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Research applications

Gene Editing

Navigate the complexities of genome engineering with highly efficient delivery.

Cell based Assays

Produce assay-ready cells faster with scalable electroporation.

Vaccine Development

Innovate vaccine research with our adaptable platform for production of recombinant proteins, virus-like particles and more.

Resources

Scientific Brief

Non-viral Engineering Approaches for Creating TCR Knockout Cells and Expressing Synthetic T Cell Receptors

Scientific Brief

A Fully Optimized CRISPR Workflow for Drug Discovery in T Cells

Scientific Brief

Generation of Heterozygous HLA-C iPSCs by ssODN Electroporation for Allogeneic Transplantation

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Electroporation Systems

Supported by numerous publications and clinical trials, our ExPERT GTx instrument is the next generation of the industry’s leading, clinically validated and scalable electroporation technology for complex cell engineering.

GTx is capable of high-performance delivery of virtually any molecule, into any cell, at any scale with the unique ability to transfect primary cells, stem cells and cell lines with minimal disturbance resulting in transfection efficiencies routinely ≥90%

Learn More about our ExPERT platform

Reagents and Processing Assemblies

MaxCyte’s consumables products provide users with a variety of project scales and throughputs for discovery up to cGMP manufacturing using a single technology platform. Our range of Processing Assemblies provide safe, medical grade devices allowing users to transfect a variety of cell sample volumes to meet their specific application needs. Combined with MaxCyte’s universal and gentle Buffer Reagents ensures consistent, high-performance transfection results.

Review Processing Assemblies