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Revolutionizing Cell Culture with Cryopreserved Pre-Plated Cell Monolayers

Cell monolayers are an ideal method and widely used in the discovery of new drug compounds and the study of cell biology. Until now, there was no cryopreservation technology available to store cell banks pre-plated commercially. The conventional approach of cell-based assay workflow was time- and resource-consuming. Now, the cryoprotectant technology CryoShield™ from CryoLogyx together with the controlled and scalable plate freeze-thaw platform RoSS.pFTU from Single Use Support, mark a revolution in commercial cell banking: Cryopreserved Thaw and Use Cell…

Astrea unveils nanofiber-based lentivirus purification tech at BWB

Astrea Bioseparations developed and launched Nereus LentiHERO in just 180 days and says the nanofiber-based technology radically transforms lentivirus purification. Bioseparation products and services firm Astrea celebrated the launch of Nereus LentiHERO at Biotech Week Boston in September at a crowded booth on the show floor. The lentiviral vector (LVV) purification tech incorporates AstreAdept, the firm’s proprietary nanofiber material, which addresses the challenges associated with purifying the large and fragile products used in cell and gene therapy. Marc Hummersone, senior…

Module Type Package: Turning Visionary Concepts Into Reality

Versatile, modular plants are the process industry’s response to constantly changing market requirements. The development of standards for integrating individual modules into the pharmaceutical production process is currently in full swing. The Module Type Package (MTP) approach designates each module with its digital description, enabling highly flexible module connection and orchestration. ZETA is currently involved in a joint modular automation initiative with Rockwell Automation. Future production plants can be assembled quickly and easily from individual modules with different functions. Depending…

Starting Strong with Quality Materials for Immune Cell Therapies

In this article, we take a closer look at key considerations for establishing a reliable supply chain of quality materials to ensure a robust and reproducible workflow for immune cell therapies. As immune cell therapies advance through the development pipeline, the need for an optimal scaling strategy becomes more apparent. Much of the deliberation centers around cell expansion approaches to attain clinically relevant cell numbers and features such as automation and process control to ensure high-quality cell products. Yet there…

Increasing Reproducibility of Cell Culture Bioprocesses

Reproducible cell growth and reliable development of a desired product are ideal outcomes for a bioprocessing engineer. If reproducibility is poor, the risk of needing to discard a batch and repeat an entire bioprocess is high and results in a great loss of time and resources. Cells, culture media, and a bioprocess control system are required components of an upstream bioprocess. Each of those can be a source of variability that affects cell growth and viability as well as product…

A Plug-and-Produce GMP Plant for Cell and Gene Therapy — Part 1: Case Study in Modular Facility Design and Deployment

The use of approved advanced therapy medicinal products (ATMPs) remains limited despite their potential to address unmet medical needs. One example uses chimeric antigen receptor (CAR) T cells for treatment of refractory lymphoma (1). Typically, such medicinal products begin with cells that are harvested from a patient and genetically programmed to recognize and eliminate tumor cells upon reinfusion. Several cell therapies based on this and other technologies are approved for use in the United States, Europe, and China (2). Given…

Overcoming Challenges in Viral Vector Production for Gene Therapy Using HEK Cell Cultures

An estimated 300 million people worldwide live with rare diseases, and over 70% of such disorders are caused by genetic mutations (1, 2). Cell and gene therapies offer hope and potential cures for many previously untreatable diseases. Accordingly, the global gene therapy market is expected to be worth USD 5.02 billion by 2028, a significant growth from USD 1.46 billion in 2020 (3). Manufacturing gene therapies will be a key challenge over the next two decades. But just a few…

Twenty Years of Innovation: Reflections on the Industry’s Past and Future

In honor of BPI’s 20th anniversary as a publication, the editors invited authors to reflect on the industry’s past, present, and future. Below, the chief operating officer of Selexis offers her perspectives along with responses to questions from the editorial team. Significant Scientific and Technological Innovations One of the most important innovations in bioprocessing has been the combination of next-generation sequencing with bioinformatics. The ability to sequence a host cell-line genome and transcriptome rapidly and cost-effectively and the development of…

Comprehensive Virus Clearance Evaluation Using Microscale Membrane Adsorbers

Membrane adsorbers can be a simple and effective choice for anion-exchange (AEX) purification of biopharmaceuticals. However, as Sherri Dolan (global technology consultant for virus clearance at Sartorius) explained during a May 2022 presentation, biomanufacturers generally do not leverage their membranes’ full loading capacities. Doing so could improve process economics and decrease costs for several downstream applications. Dolan’s Presentation Membrane adsorbers are ideal for flow-through AEX applications (e.g., secondary purification and polishing) because they can be used at high flow rates…

Analytical Tools for Improving Up- and Downstream AAV Process Development

During a May 2022 Ask the Expert presentation, Ivana Petrović Koshmak (head of upstream process development at BIA Separations, part of Sartorius) highlighted the gene- therapy industry’s need for fast, reliable analytics that work with both up- and downstream samples. High-performance liquid chromatography (HPLC) methods can fulfill that need, but process development (PD) scientists would need to account for the complexity of bioreactor samples to make such methods feasible for end-to-end analytics. Koshmak described a novel instrument that is designed…