iPSC solutions for Cell & Gene Therapy

Ncardia is a human iPSC-dedicated service organization specialized in contract process development and manufacture of Cell and Gene therapies. Our demonstrated expertise in iPSC generation and differentiation protocol development makes us well positioned to support Cell and Gene therapy developers in the creation of therapeutic cells.

Process Development

Over 15 years of experience in developing manufacturing processes for induced pluripotent stem cells has equipped us with the experience to design and optimize manufacturing procedures that deliver quality products to scale.

Ncardia has established history in cardiovascular and CNS cell model development and manufacture. Additionally our technologies are applied to any other cell lineage. Each project uses Quality by Design (QbD) approaches for cost-effective and rapid process development to scale.

Scalable Manufacturing

Human iPSC technology provides a renewable resource for the consistent manufacture of well-defined cell therapies. We work with you to establish a robust manufacturing process that can be reproduced reliably at scale in the most cost-effective manner.

Our manufacturing procedures utilize proven bioprocessing technologies for adherent and suspension approaches. All reagents and processes are subject to a quality control system and standard operating procedures. Final product and in-process quality testing, such as identity and functionality assays, is employed for product release. Cell culture media are typically fully defined to ensure robust processes that yield functional cells ready for your specified downstream application.

Quality Commitment

International quality standards (ISO) guarantee consistency and reproducibility. We are certified and regularly audited to these standards as a commitment to our clients. The result is that your custom product is delivered to specification every time.

You can be confident in our ability to manufacture and release products with product quality and safety in mind. We routinely utilize relevent document management standards, qualification and validation methods, material and vendor qualifications, manufacturing CAPAs and formalized personnel training.

Project process

1. Initial inquiry

An initial inquiry is created through the website, email or a business development representative.

2. Consultation

Consultation with a cross-functional Ncardia team to discuss your request, understand your needs and formalize expectations.

3. Expert team

Your proposal is assigned a lead scientist, project manager and expert support team.

4. Project plan

We will produce a detailed manufacturing plan including timelines and milestones that minimize complexity, time, and risk.

5. Fine-tuning

Optimization of cryopreservation formulation, controlled-rate freezing for cryopreserved products, and custom medium bottling.

6. Execution

Large-scale manufacturing and QC testing by our expert staff.

7. Delivery

Safe and on-time delivery of your custom product, either cryopreserved or directly plated on the desired assay plates.

8. Feedback

We would love to hear your feedback and discuss your next project.

Key Manufacturing Technologies

3D Platform

Controlled bioreactor manufacturing

2D Platform

Adherent monolayer culture and scale-up

Custom culture medium