Cell banking stands at the forefront of medical advancement. This guide delves into the steps involved in protecting these priceless resources, from cell collection and processing to storage and cell expansion.

An alternative to traditional polyethylene bags is offering cell and gene therapy manufacturers a solution to contamination concerns regarding DNA or RNA fragments.

Examine the benefit of using fluoropolymer film bags for the handling and storage of high value oligonucleotides- based payloads.

Entegris announces their collaboration with Agilitech, allowing them to offer an extended line of custom, single-use systems for cell and gene therapies.

Explore traditional cold-wall and convection technology to determine which best suits your cold needs for upcoming projects.

Compare single-use system bags and learn why both particulate levels and minimizing contamination are important for single-use systems.

Learn about the three most common sources of filtration failures and how to prevent these problems.

Learn about large and small volume parenteral injectable drugs, their comparative sizes, types, sterilization processes, and applications.

The FDA holds strict requirements for magnetic bead removal prior to therapeutic use. Learn how this system effectively separates cells from microcarriers and provides maximum cell recovery.

Examine one company's solution to minimizing production delays despite the single-use supply constraints exacerbated by the COVID-19 pandemic that are interfering with bioprocess operations.

Freezing biologics is a complex undertaking. As more biotherapies enter the market, ensuring manufacturers have the technology to optimize their cold chain applications is paramount.

The need for low-temperature storage capable of surmounting the molecular and logistical challenges associated with these treatments has become core to achieving commercial-scale production.

We investigate material adsorption of mRNA-encapsulated lipid nanoparticle (LNP) formulation comparing the Aramus fluoropolymer bag to commonly used glass vials and polypropylene (PP) cryotubes.

This application note explains the use a liquid particle counter to qualify the cleanliness of single-use 2D bag assemblies.

New single-layer assemblies, made without the curing agents, antioxidants, plasticizers, or adhesives that represent potential contamination sources, may offer companies a safer, more efficient choice.

This application note reviews the chemical compatibility of Aramus™ assemblies with dimethyl sulfoxide (DMSO), which is commonly used as a cryopreservant in the cell and gene therapy (CGT) markets.

This application note explores the cryogenic temperature compatibility of the Aramus™ bag assembly material through freezing and drop testing after 24-hour minimum immersion in the liquid nitrogen (LN2) vapor phase.

This application note demonstrates how the Nicomp Z3000 system is ideally suited for determining size and zeta potential of gold nanoparticles.

Understanding the cold chain supply scale-up challenges that can threaten product integrity empowers manufacturers to implement efficient, cost-effective solutions.

The size and surface charge of liposomes—spherical engineered particles made of phospholipids—are important characteristics that require measurement and monitoring in biopharmaceutical applications. 

Listen to the Questions asked by the audience during this Cell & Gene Live Event, How To Reduce Batch-to-Batch Variation In Cell Therapy Manufacturing, along with the answers by our professionals.

In this excerpt from Cell & Gene Live's How To Reduce Batch-to-Batch Variation In Cell Therapy Manufacturing, experts share why changing from a manual process to an automated process is critical.

Explore why expectations grow along the curve and why understanding what's expected early on is important.

The more data you have, the more data you can feed into whatever analytical algorithm you build. And as such, the more reliable the outcome.

In this segment, our expert panelists address why apheresis material for autologous cell therapy is subject to variability related to its limited quantity, the differences between patients, and the differences across apheresis facilities.

Dive into understanding both auto and allo and why you would also have the supplier or the vendor sign up to address problematic root causes with your batch-to-batch variability.

In this segment, our expert panelists cover the variability drivers for allogeneic cell therapies, the criteria or non-negotiables for a healthy donor, as well as the biggest challenges in batch-to-batch variation for allogeneic cell therapy manufacturing.

There is a need to understand the target product profile and what the product is. What do you expect it to be? What is your proposed mechanism of action and how do you intend to monitor it?

Why understanding composition and what may or may not interfere in your culture process is key to operations in reducing variability.

Listen to tremendous detail around the challenges facing autologous cell therapy manufacturing, from the need for automation in manufacturing to the sourcing of tissue from a specific patient.

Hear about the root of variation in cell therapy manufacturing, the different stages of hematological reconstitution depending on those treatments, and the variability among each person’s cells as well as manufacturing processes.

Review data and evidence that demonstrates the benefits of an integrated approach to achieving critical end-user goals such as scalability, efficiency, sustainability, and optimized process economics.

Listen in to real-time questions and answers from the audience. During “Building An In-House Cell & Gene Manufacturing Facility – Best Practices & Lessons Learned.”

Take a look into how automated instruments promote process and product standardization, assist in eliminating the variable human factor of manual processes, and address the complexity of manufacturing life-saving therapeutics.

Does or should speed to clinic impact a company’s decision to build versus buy? Explore this question and others along with lessons regarding capacity and meeting anticipated demand.

When building a production line from lab-based processes, sometimes staff primarily familiar with research might not know the specifics of regulations relating to late-stage drug production.

Learn about some of the major milestones and timelines that must be met throughout the building process with a pharmaceutical manufacturing expert.

Manufacturers know that an empty GMP facility costs a great deal of money, so how can companies balance the cost and labor model.

Are you and your manufacturing team ready to take on the demands of Good Manufacturing Practices, compliance, and regulatory approval?

Discover how to integrate appropriate materials and tools for oligonucleotide handling, optimize DNA storage using dedicated fluoropolymer film, perform complex biochemical reactions in bags, and more.

Watch how our single-use mixing system creates a completely sterile mixing and recirculation process, ensuring your buffer and media are mixed correctly and efficiently.

Ross Acucena, applications director, and Donnie Beers, product manager, introduce our single-use mixing system made to be deployed rapidly to help manufacturers meet development, supply, and cost objectives.

Ross Acucena, applications director, and Donnie Beers, product manager, introduce our highly functional and adaptable microcarrier cell separation bags designed for single-use processes. 

Explore how filtration manufacturers optimize materials for performance and integration within single-use systems, including the value of optimizing sterile filtration by design and how it integrates and maximizes performance.

Learn how utilizing high-density cell banking workflows in combination with your already intensified upstream process can further enhance your process productivity while reducing contamination risks.

Learn about particle sizing methodology, equipment, software, and compliance to meet USP standards for parenteral drug manufacture, proteins, ophthalmic solutions and lipid emulsions.

Entegris' Joy Xiaohui Chen and Cari Sadowski of Fujifilm Diosynth Biotechnologies evaluate single-use bag material interaction and adsorptive relationship with AAV viral vector during storage.

Learn more about the uncertainties and complexities encountered when expanding the application of single-use technologies (SUT) in cryogenic bioprocesses.

Study data shows the utility of low temperature suitable materials and packaging,  sensors for monitoring shipments, and qualification and evaluation through simulated standards and real-world transit.

How high-density cell banking accelerates upstream processes by providing a larger volume of concentrated cells at the start of a production run, shortening seed training from weeks to days. 

Explore the needs and requirements of equipment and processes to handle lower temperatures, incuding a complete, cold-resistant solution of bags, tubing, connectors, and shells for freeze/ship/thaw processes.

This video shows examples of the performance of Aramus™ film, polyethylene, and polyolefin film when subjected to cold temperatures.

Janelle Rupkalvis from Entegris Life Sciences describes the options, technologies and suppliers for single use assemblies in low temp bioprocessing.

Janelle Rupkalvis describes the process and options for ordering single use assemblies from Entegris Life Science.

Mike Johnson from Entegris and Johannes Kirchmair from Single Use Support explain the importance of having a complete, cold-resistant solution of bags, tubing, connectors, and shells.