Articles and application notes

6 Misconceptions about automating cell therapy manufacturing

6 Misconceptions about automating cell therapy manufacturing

By using automation to minimize human interaction and time and resource requirements, you can increase your product’s speed to market and mitigate many of the risks and costs associated with commercialization.
AAV production using microcarriers

AAV production using microcarriers

Large-scale AAV production processes are needed to industrialize gene therapies. This customer case study describes microcarrier culture in a 1 L bioreactor.
AAV production in suspension HEK293 cells with single-use bioreactors

AAV production in suspension HEK293 cells with single-use bioreactors

How we developed and scaled up transfected HEK293 suspension cell production of AAV — from shake flasks to production bioreactors.
Add it up: three things to consider for capacity expansion

Add it up: three things to consider for capacity expansion

In this panel discussion, cell therapy industry leaders weigh in on the need for scalable, flexible, and proven solutions. Read along as they also address issues such as time constraints, bandwidth issues, scientific expertise, and staffing shortages.

Addressing the challenges of cell therapy starting material

Addressing the challenges of cell therapy starting material

Cytiva’s Cell and Gene Therapy Biology Director, Bill Shingleton, outlines the innovative solutions that help to efficiently preserve, track, monitor, and transport cell therapy materials, from the patient to production and back.
Advantages of Fibro chromatography for AAV purification

Advantages of Fibro chromatography for AAV purification

Fast residence times for Fibro technology allowed much shorter process time with similar recovery and purification performance as affinity resins.
Apheresis variability control

Apheresis variability control

Reduce variability in cell therapy manufacturing with standardized, automated management of apheresis product and process control strategies for MNC enrichment.
Automated bag thawing system for CAR-T cell therapy manufacturing

Automated bag thawing system for CAR-T cell therapy manufacturing

VIA Thaw™ dry thawing system shows comparable performance to a water bath with less handling
CAR T cells: closed and semi-automated processing

CAR T cells: closed and semi-automated processing

A robust workflow that can be adapted for cGMP compliance in commercial production. Achieves 1 × 1010 expanded T cells in 8 days.
CAR T cell process development study

CAR T cell process development study

Manual, open processing is not ideal for commercial production of chimeric antigen receptor (CAR T) cells. This study describes development of a closed and semi-automated process that can be adapted for GMP compliance and CAR T developers’ needs.
Case study: lentiviral vector process development

Case study: lentiviral vector process development

Development of a scalable process to produce high-yield lentiviral vector batches using stable, suspension-based production methods.
CBMG and Cytiva collaboration

CBMG and Cytiva collaboration

CBMG accelerates cell therapy manufacturing with Cytiva’s start-to-finish FlexFactory for cellular therapies.
CDMOs and tech providers collaborate to make AAV efficiently

CDMOs and tech providers collaborate to make AAV efficiently

Panel discussion on how working together amplifies individual know-how to ensure client needs are met
Cell culture process development for AAV vector production in suspension cells

Cell culture process development for AAV vector production in suspension cells

Adaptation of HEK293 suspension cell line for transient transfection and scalable adeno-associated virus (AAV) production
Consistent cord blood cryopreservation

Consistent cord blood cryopreservation

Customer study shows reproducible cord blood freezing without liquid nitrogen.
Controlled endpoint in cryopreservation

Controlled endpoint in cryopreservation

This study was designed to answer the question: When is it safe to transfer cell samples from a controlled-rate freezer to liquid nitrogen storage?
Cryopreservation techniques to maximize T-cell viability

Cryopreservation techniques to maximize T-cell viability

T-cell cryopreservation is a critical step in cell therapy storage and transport. We share tested cooling techniques and tips to maximize cell viability, including how quickly to freeze cells and when to stop.
Delivering LN<sub>2</sub>-free multi-bag cryopreservation

Delivering LN2-free multi-bag cryopreservation

A proof-of-concept study that demonstrates the controlled cooling of large volume biological samples with high and consistent post-thaw recovery. An alternative solution to cryopreserving with liquid nitrogen.
Developments in cell expansion for cell processing

Developments in cell expansion for cell processing

Expand your knowledge on perfusion, our rocking technology and more by reading through our latest papers and posters.
Enabling LN2-free large-volume cryopreservation in vials

Enabling LN2-free large-volume cryopreservation in vials

Cooling protocol and proof-of-concept study for the cryopreservation of large-volume biological samples in cryovials. Achieve high and consistent post-thaw recovery of up to 50 mL in this liquid nitrogen-free cell freezing method.

Gene transfer by spinoculation

Gene transfer by spinoculation

SpinOculation C-Pro protocol software offers a closed, automated solution for gene transfer by lentiviral transduction in CAR-T cell therapy processing.
Cryopreservation techniques to maximize T-cell viability

Cryopreservation techniques to maximize T-cell viability

T-cell cryopreservation is a critical step in cell therapy storage and transport. We share tested cooling techniques and tips to maximize cell viability, including how quickly to freeze cells and when to stop.
How and when to get started with GMP

How and when to get started with GMP

Two cell therapy experts provide practical advice on when and how to start thinking about compliance with good manufacturing practices (GMP).
How to optimize and scale up AAV production: panel discussion

How to optimize and scale up AAV production: panel discussion

Leaders from academia and industry engage on topics from technology to ways of working
Improving viral vector manufacturing

Improving viral vector manufacturing

How to prepare for the future of viral vector production to meet the demand generated by gene-modified cell therapies and gene therapies. Based on interview with Phil Vanek.
Interrupted cooling in cryopreservation

Interrupted cooling in cryopreservation

How does a power interruption during cooling affect post-thaw cell viability? This study demonstrates minimal effect of power outages and interrupted cooling during cryopreservation when using a VIA Freeze controlled-rate freezer.
Is a rapid cooling step needed?

Is a rapid cooling step needed?

This study shows comparable results when freezing cells with or without a rapid-cooling nucleation step.
Large scale AAV for preclinical gene therapy studies

Large scale AAV for preclinical gene therapy studies

GLP grade viral vector is suitable for these studies and avoids the infrastructure costs of GMP grade.
Lentiviral vector upstream process

Lentiviral vector upstream process

Upstream lentiviral vector process with stable producer cell line that can be adapted for commercial manufacturing. Scales linearly from 5 to 28 L in Xcellerex bioreactors yielding ≥ 1010 TU/L of LV-GFP.
Liquid nitrogen-free cryogenic shipping of cell products

Liquid nitrogen-free cryogenic shipping of cell products

We share results from evaluation trials conducted by CSL Behring using the VIA Capsule™ system for liquid-nitrogen free cryogenic shipping and temporary storage of cellular products.
Liquid nitrogen-free cryogenic transport of cell therapies

Liquid nitrogen-free cryogenic transport of cell therapies

Cryopreservation plays a critical role in getting cell therapies to patients. Here, we describe a study using the easy, flexible, liquid nitrogen-free VIA Capsule™ system for controlled transport of cryopreserved treatments.
mRNA vaccines: current trends and perspectives

mRNA vaccines: current trends and perspectives

The promise and challenges of mRNA vaccine development
Natural killer cells manufacturing

Natural killer cells manufacturing

Workflow for NK cell production from apheresis units. Isolation, xeno-free expansion, harvest, and cryopreservation amenable to GMP manufacturing.
Oncolytic adenovirus production

Oncolytic adenovirus production

Customer case study describes a robust upstream process and downstream process for oncolytic adenovirus production. Purity of final samples meets regulatory requirements.
Optimizing capture and polishing steps in an rAAV purification process

Optimizing capture and polishing steps in an rAAV purification process

Scalable, cost-efficient, and robust filtration and chromatography-based processes are required for the purification of adeno-associated virus (AAV) in bioprocessing. In this article, we show how we developed an efficient purification process for recombinant AAV (rAAV).

Optimize your cell therapy process — a guide to cell thawing

Optimize your cell therapy process — a guide to cell thawing

Cell therapy thawing is a complex and critical step in getting treatments to patients in need. We developed this guide to outline the science of thawing and present methods for maintaining cell viability and treatment efficacy.

Optimizing recovery on the Sepax™ cell processing system

Optimizing recovery on the Sepax™ cell processing system

Review our recent study highlighting a closed and automated process for cell therapy dilution, concentration, and washing steps using the CultureWash C-Pro application on the Sepax C-Pro cell processing system.
Producing consistent and compliant cell therapies

Producing consistent and compliant cell therapies

A new software platform is designed to simplify cell therapy processes. It offers many features and a single digital space to support both consistent production and compliance with regulations such as cGMP.
Recombinant adeno-associated virus type 5 production process

Recombinant adeno-associated virus type 5 production process

A scalable recombinant adeno-associated virus (rAAV) type 5 production process was developed using transfected HEK293 suspension cells.
Reducing gene therapy production costs

Reducing gene therapy production costs

In an industry forum, leaders discussed challenges and insights related to reducing the cost of goods for gene therapy.
Scalable AAV production process for gene therapy

Scalable AAV production process for gene therapy

See how we developed an AAV cell culture process that successfully scaled to 20 L for several serotypes
Scalable AAV purification process for gene therapy

Scalable AAV purification process for gene therapy

See how we developed a scalable AAV chromatography and filtration process for AAV purification. And see results from a new viral titer assay for AAV2.
Security of supply in cell and gene therapy manufacturing

Security of supply in cell and gene therapy manufacturing

Building an adequate supply chain with the necessary equipment and protocols is critical for companies pursuing cell and gene therapies. Cytiva realized the importance of this need and implemented a Security of supply program.
Secure the cell therapy supply chain from bench to bedside

Secure the cell therapy supply chain from bench to bedside

The cryogenic supply chain of cell therapies presents challenges to the delivery of cell samples. Find out about approaches to help mitigate these risks.

Supporting a greener supply chain

Supporting a greener supply chain

VIA Capsule™ shipper helps reduce costs and carbon footprint for cell therapies
The Supply Chain Challenge

The Supply Chain Challenge

Overcoming the challenges of manufacturing and administering a complex product to any patient is critical for delivering cell therapies. Here two industry experts provide practical advice on strategies to meet supply chain challenges.
TIL sample collection and processing

TIL sample collection and processing

There is an opportunity to automate and standardize workflow steps to improve outcomes of tumor-infiltrating lymphocyte (TIL) therapies.
Top questions on making AAV vectors for gene therapy

Top questions on making AAV vectors for gene therapy

Cytiva scientists answer top questions on making AAV vectors for gene therapy.
Tumor-infiltrating lymphocytes as cell therapies

Tumor-infiltrating lymphocytes as cell therapies

TILs are showing promise as cancer treatments for solid tumors. Learn what they are and how they differ from CAR T cells.
Unifying cell therapy logistics and manufacturing

Unifying cell therapy logistics and manufacturing

For cell and gene therapies, the supply chain and logistics are critical. Collaboration is the key to solving data management and process variability challenges.
Water free vs water bath cell thawing

Water free vs water bath cell thawing

Read about this benchmarking study and benefits of dry thawing technology.
Will automation transform the speed and efficiency of cell therapy manufacturing?

Will automation transform the speed and efficiency of cell therapy manufacturing?

Automation is helping translational research centers to standardize protocols, improve quality control, and integrate systems for cell therapy manufacturing, resulting in less risk and faster treatment timelines.
Xuri™ IL-2 stability study for cell therapy manufacturing

Xuri™ IL-2 stability study for cell therapy manufacturing

Cytokine stability is critical in manufacturing immune-based therapies. We studied Xuri™ IL-2 concentration over 8 days in multiple media formulations.
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VIA Freeze controlled rate freezers