Production of CGMP-Grade Lentiviral Vectors

Lentiviral vectors are important tools for gene transfer because of their ability to transduce a number of cell types without the need for host cells to be dividing. As a result, investigators are using them as gene delivery vehicles in clinical applications. Since lentiviral vectors play such a vital role in gene therapy, they need to be manufactured at large scale for clinical trials. But, large-scale production using CGMP methods can present a number of challenges.

To address these challenges, the authors of this case study developed a process that allows for extensive scale-up in a safe, sterile, and reproducible system to produce clinical-grade lentivirus. This manufacturing process is very efficient and can be carried out using minimal staff (two operators for production of each subbatch). It provides the extensive scale-up capacity necessary to produce CGMP-grade lentivirus, and it has been used successfully in several completed and on-going phase 1–2 ex-vivo gene therapy clinical trials.

Meeting Increased Demands on Cell-Based Processes By Using Defined Media Supplements

As the demand for cell-derived products is rapidly increasing, there are huge pressures on the biomanufacturing industry’s production capacity requirements. To keep up with this demand, more focus is being put into media development strategies for optimizing output from cell culture systems. Serum-based media have traditionally been used to address the individual nutrient requirements of animal cells used in manufacturing protein products, but are now being gradually phased out due to inconsistencies and potential contamination risk.

These factors have created a demand for development of serum-free media that deliver optimal cell growth and productivity. This white paper looks at the challenges facing biopharmaceutical manufacturers today and the role of defined media supplements in addressing those.

Modeling Perfusion Processes in Biopharmaceutical Production

Biopharmaceutical manufacturing is mostly batch-based for a number of reasons: lower perceived contamination risks, batch-to-batch segregation, and historical legacy. Despite those reasons, perfusion is used by a number of biomanufacturers because it produces large product quantities using smaller bioreactors than would be possible with batch-based production.

Though perfusion-based production presents challenges that confound traditional models, it can create an environment in which many more factors can be influenced to directly optimize production. Read this case study to learn more about how perfusion can be used to create flexible, “just-in-time” facilities that respond to manufacturing conditions.

Integrity Systems: A Comprehensive Toolkit for Single-Use Solutions

Single-use solutions are in growing demand within the biopharmaceutical manufacturing industry. With a complete line of solutions — from mixing systems to ultra-clean packaging — ATMI LifeSciences is a leader in these technologies. In this educational webcast, Jared Hisle, Global Product Manager at ATMI LifeSciences, explores the full line of Integrity™ Systems single-use technologies, including:

• NewForm™ Sterilizable Packaging
• Integrity™ Liquid and Powder Vessels
• Integrity™ Mixers
• Integrity™ Bioreactors

ATMI maintains the world’s largest installed base of single-use mixing systems and offers the world’s only single-use platform including film extrusion. Join Hisle as he demonstrates the advantages of ATMI’s single-use solutions.

Quality by Design (QbD): Defining Hydrolysates & Designing Quality

Complex. Undefined. Variability. These are all typical attributes that are used to describe protein hydrolysates because they are exactly that — complex, undefined and their performance may vary on a lot-to-lot basis. But despite all of the uncertainties, using hydrolysates as media supplements can stimulate cell growth and improve protein production — and ultimately lower the cost of goods tremendously. That is why the scientists at FrieslandCampina Domo have started the project “Defining Hydrolysates and Designing Quality.”

In this educational webcast, Dr. Jan Boots of FrieslandCampina Domo answers the questions — Can hydrolysates be defined? And can consistent quality be designed into them? Join Dr. Boots as he explores the complexity of hydrolysates and how Domo is working to define them.

Potelligent® CHOK1SV: The Evolution of the GS Gene Expression System™

Lonza and BioWa have combined their technologies to produce a new host cell line, Potelligent® CHOK1SV. This new cell line merges the benefits of Lonza’s GS Gene Expression SystemTM with those of BioWa’s POTELLIGENT® technology. Recombinant cell lines created using this new and improved host cell line have shown:

• Enhanced ADCC
• Growth suitable for a production process
• High product concentration levels in a platform process
• Ability to work seamlessly with current manufacturing processes

Join Allison Porter of Lonza Biologics as she provides a detailed look at the two technologies separately and the performance of the new Potelligent® GS-CHO technology.

Anatomy of a Single-Use Bioreactor Deployment

Rapid commissioning and start-up enabled by system design and process support

Deploying a new GMP single-use bioreactor requires the careful coordination of hardware, software, disposable components, process engineering, tech-transfer and other disciplines. When time pressure is involved as it often is in the current business environment, the task of mastering an unfamiliar piece of process equipment can provide a challenge to biopharm organizations. Recognizing this, Xcellerex has designed the XDR single-use bioreactor as a fully-integrated system that is engineered for rapid delivery and start-up, capable of going from order to delivery to working process in just 12-16 weeks. Further, the Xcellerex team uses XDR reactors every day in our own GMP operations, allowing our technical team to provide fully informed support to customers. This webinar provides an overview of XDR deployment capabilities, and shares a recent customer case history of a successful rapid XDR deployment.