Industry thought leaders working in the viral vector manufacturing space recently participated in a Virtual Think Tank (VTT), a unique thought leadership platform that brings together leading minds, to discuss viral vector manufacturing facility design. The focus of the most recent VTT was on the current challenges and trends influencing design considerations for viral vector manufacturing facilities and how they can impact companies developing cell and gene therapies.

It wasn’t Paris in Spring, but the annual meeting of the International Society of Cellular Therapy (ISCT) 2020 did happen in May, albeit virtually. From the comfort of their home office with snacks at the ready, attendees devoured sessions on some key topics of the day through a cool digital interface replete with avatars. Here are my highlights on a session that introduced a new way to ship and transport cellular materials, putting patients front and center.

Illustrating how mammalian cells change when frozen, we offer cryopreservation strategies and identify temperatures at which it's safe to stop controlled cooling and transfer drug product to cryogenic storage.

How can you intensify your cell culture processes, in order to keep pace with today’s industry and regulatory expectations?

The (re)emergence of small biotechs in the biosimilar world has caught my eye in the last year. I sat down (virtually) with the CEO of one such company, BiosanaPharma, to discuss the advantages and challenges of being a virtual biotech pursuing biosimilar and novel biologic development.

Your automation strategy can be designed to expand with your business if you consider your choices in the initial stages. Early platform design selections can greatly affect your future flexibility and ability to show compliance throughout regulatory reviews.

This article will examine the relationship between improved continuous manufacturing (CM) and biosimilar development, paying particular attention to the reasons why biosimilars are especially promising candidates for CM development and innovation.

Get insights into implementing a robust business continuity management program that can help secure supply, reduce risks, and maintain quality in manufacturing operations, through a crisis situation.

Biomanufacturing is trending towards higher numbers of monoclonal antibody (mAb) projects and smaller batch sizes, with production of most mAbs below 100 kg/yr. These trends are fueling demands to screen more clones faster and improve the efficiency of process development (PD). Read how the Fibro PrismA unit provides a time advantage with comparable recovery and product quality attributes to resin-based column.

Standardized approaches to biomanufacturing can lower costs, improve outcomes and alter the landscape of the global pharmaceutical market.

In this study, the hydrophobicities of newer generation Capto HIC resins were compared to Sepharose High Performance and Sepharose Fast Flow HIC resins.

In biopharma, process data is used in many ways throughout process development and production phases. This article outlines how connectivity and comprehensive automation ease tech transfer and scale up.

Managing today’s supply chain complexity begins by transforming historically transactional relationships to those that drive suppliers to value-added status, working toward shared customer goals.

Following the news of Fresenius Kabi’s new biosimilar R&D lab, I reached out to one executive to discuss the current challenges in biosimilar R&D, including maintaining the delicate balance between biosimilar R&D and commercial teams as Fresenius Kabi prepares for a long future in the biosimilar space.

The industry has shown surprising resilience and consistency, emerging relatively unscathed from the recession at the beginning of the past decade. Capacity and expansion were relatively unaffected and continue to draw investors seeking healthy returns and a recession-resistant risk profile.