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 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.
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.
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 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.
Digitizing your cell therapy GMP environment

Digitizing your cell therapy GMP environment

GMP facilities generate a lot of data. What if there was a way to safeguard that data while saving time and money? Here’s how one team implemented Chronicle™ software as an enabling tool for digital integration and management of all SOPs and data.
Effective separation of full and empty adeno-associated virus capsids by anion exchange

Effective separation of full and empty adeno-associated virus capsids by anion exchange

We have developed a protocol for near complete separation of full and empty viral capsids for recombinant AAV2, AAV5 AAV8, and AAV9 serotypes.
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 application software offers a closed, automated solution for gene transfer by lentiviral transduction in CAR-T cell therapy processing.
Harvesting and formulation of stem cells using Sepax™C-Pro systems

Harvesting and formulation of stem cells using Sepax™C-Pro systems

Parameter guidelines for small final product volume ensuring high recovery of > 82% and viability, always maintaining pluripotency.
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.
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 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

Dive into the specifics of a natural killer cell production workflow: 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.
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 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).

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.
rAAV production using HEK293 cell line and transfection medium

rAAV production using HEK293 cell line and transfection medium

Improving the performance of a scalable AAV process in Xcellerex™ XDR-10 and XDR-200 bioreactors using HyClone™ peak expression medium
Recirculation/perfusion guide for the iCELLis bioreactor

Recirculation/perfusion guide for the iCELLis bioreactor

General considerations to develop the recirculation/perfusion process on iCELLis® Bioreactor for efficient adherent cell culture process
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
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.
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.
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.

Shifting gears: why cell therapy systems are going automatic

Shifting gears: why cell therapy systems are going automatic

Learn why cell processing is moving from manual techniques to new modular, automated technologies.

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.
Optimize oligo synthesis with AKTA oligosynt synthesizer

Optimize oligo synthesis with AKTA oligosynt synthesizer

Get the most out of your ӒKTA oligosynt™ oligo synthesizer using designed-in consumables to enhance your purity and yield. Lean on our decades of experience to optimize your oligo workflow.
Lentiviral vector production using single-use bioreactors

Lentiviral vector production using single-use bioreactors

Developing a scalable lentivirus vector production process using HEK293T suspension cell line in single-use bioreactors
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.
Exosome isolation by tangential flow filtration and size exclusion chromatography

Exosome isolation by tangential flow filtration and size exclusion chromatography

A scalable workflow for the isolation of exosomes by tangential flow filtration (TFF) and size exclusion chromatography (SEC).
Genomic medicine demands manufacturing innovation

Genomic medicine demands manufacturing innovation

Genomic medicine keeps innovating, and manufacturing innovation must keep pace if we are to realize the full potential of these transformative therapies.
Viral vector producer cell lines learning from mAbs

Viral vector producer cell lines learning from mAbs

Cell line development has helped break through bottlenecks for bioprocessing and made some mAbs blockbuster therapies. We can succeed faster with a similar approach for viral vectors, armed with this cell culture and engineering knowledge.
Successfully isolate your T cells using MagnetSelect

Successfully isolate your T cells using MagnetSelect

How to use Sefia Select™ system with MagnetSelect to automate your T cell isolation process for CAR T cell therapy manufacturing
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